Low back pain: evidence from clinical practice. Observational longitudinal study on 182 patients - Pathos

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Low back pain: evidence from clinical practice. Observational longitudinal study on 182 patients

Dolore lombare: evidenze dalla pratica clinica. Studio osservazionale longitudinale su 182 pazienti
Observational study
Pathos 2021; 28, 3. Online 2021, Oct 31
Claudio Santoro,1 Michela D'Oro,2 Jessica Vella2
1 Laboratorio di Neurologia Funzionale
2 Laboratorio di Biomeccanica
Centro Ricerche Disfunzioni Meccaniche Osteolab, Benevento, Italy

Low back pain is among the disorders with the greatest social and economic impact in the Western world.
The present study refers to 182 requests for intervention for low back pain received by the Research Center of Mechanical Dysfunctions of Osteolab (Benevento, Italy), in the period January 2, 2019 - May 31, 2019. The data collected made it possible to recognize manual medicine as suitable and effective therapy in pain treatment and in the resolution of functional lesions from which it arises (t = 84.354, p <.0001). The data collected also made it possible to define - both in quantitative and qualitative terms - how much the lesions (classified as DL0, DL1, DL2, DL3, DL4) affect the onset of back pain, but also to understand how much the presence of "signs of hypotrophy" (considered as biomarkers) is involved in its development.
La lombalgia è tra i disturbi a maggior impatto sociale ed economico nel mondo occidentale. Lo studio si riferisce a 182 richieste di intervento per lombalgia pervenute al Centro Ricerche Disfunzioni Meccaniche di Osteolab (Benevento, Italia), nel periodo 2 gennaio 2019-31 maggio 2019. I dati raccolti hanno consentito di riconoscere la medicina manuale come idonea ed efficace nel trattamento del dolore e nella risoluzione delle lesioni funzionali da cui lo stesso scaturisce (t=84.354, p<.0001). Hanno altresì consentito di definire in che termini quantitativi e qualitativi le lesioni (classificate come DL0, DL1, DL2, DL3, DL4), incidano sull’insorgenza del mal di schiena, ma anche di comprendere quanto la presenza dei “segni di ipotrofia” (inquadrati come biomarcatori) sia coinvolta nello sviluppo dello stesso.
Key words
Low back pain, observational study, functional injiuries, hypotrophy, manual medicine, chiropratic, osteopathy
Parole chiave  
Lombalgia, studio osservazionale, lesioni funzionali, ipotrofia, medicina manuale, chiropratica, osteopatia
Subacute and chronic low back pain are among the disorders with the highest social impact, especially in the Western world, often considered of great relevance not only from a medical point of view, but also from a socio-economic one.1 As a matter of fact, this kind of disorders entail high social and individual costs, both in terms of diagnostic tests and therapeutic interventions and, for the individual, in reduced productivity, heavily impairing the patient’s daily life activities.2

The different duration of pain defines three temporal phases which correspond to three degrees of severity:
- The acute phase lasts less than four weeks and is characterized by intense, highly painful and disabling symptoms. It affects 75-90% of patients seen in primary care outpatient clinics. According to the literature, after appropriate drug treatment, the pain seems to improve within a month.3
- The subacute phase lasts from four weeks to three months. It affects 25-50% of patients and is a morbid condition characterized by moderately intense and potentially disabling pain: despite the beneficial effects of the pharmacological treatment, minimal symptoms persist and exacerbate in the following year.
- The chronic phase lasts more than three months. It affects 6-10% of patients and is characterized by constant, moderately painful, highly disabling symptoms. In this phase, drug treatment is clearly ineffective.4
Numerous prospective studies have tried to identify not only which factors are revealing of acute low back pain, but also to define the mechanism that causes the transition from acute pain to chronic pain, or the development of disabling conditions.5  The only reliable data, however, only refers to etiological aspects, along with multiple factors;6
• increased stiffness, resulting in muscle contractions which, in turn, hinder free movement even more;
• increased pressures and potential loss of cushioning function performed by the intervertebral discs.
Low back pain is therefore the result of a number of factors that, on a daily basis, only indirectly affect the spine (gravity, sedentary lifestyle, psychological factors, emotions, work activity, degenerative problems, etc), since they inevitably affect the support structures (muscles). To these conditions are often associated constitutional factors (genetic heritage, age, sex, stature, spinal canal size). Therefore, low back pain should not be considered a pathology in a strict sense, but it should be seen as an alteration of function, a result of imbalances involving different body structures. Randomized studies have shown that only 10-20% of cases of low back pain are caused by a specific problem of the spinal column (rachis pathologies) while, for the remaining 80-90% cases, it is believed that non-specific causes intervene in the onset of pain, causes which are often linked to undiagnosed disorders associated to the viscera.
According to the studies conducted by Deyo et al,5  the common causes of low back pain can be classified as:
1. Mechanical (80-90%)
- Unknown causes, generally related to muscle strain or ligament damage
- Degenerative disc disease or arthropathy (vertebral fracture and/or congenital deformities)
- Spondylolysis (instability)
2. Neurogenic (5-15%)
- Herniated disc, stenosis of the spinal canal, infections (such as herpes zoster)
- Osteophytic neoformation on the nerve root
- Annular fissuring and consequent chemical irritation of the nerve root
- Failed back surgery syndrome (arachnoiditis, epidural adhesions, recurrent herniations)
3. Non-mechanical spinal conditions (1-2%)
- Neoplasms (primary or metastatic), infections (osteomyelitis, discitis, abscesses)
- Inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, enteropathic arthritis...)
- Paget's disease, other (Scheuermann's disease or Baastrup disease)
4. Reported visceral pain (1-2%)
- Gastrointestinal diseases (chronic bowel disease, pancreatitis, diverticulitis), kidney diseases (nephrolithiasis or pyelonephritis)
5. Other (2-4%)
- Fibromyalgia
- Factitious disorder (of pain)
Along these same lines, some studies tend to simplify low back pain classification by only identifying, in general, the mechanical or neuropathic nature of the condition (when the mechanical and neuropathic causes are not secondary to other causes). Mechanical low back pain affects the spinal column or some supporting structure, generating soreness and what the patient describes as a throbbing sensation; the neuropathic cause, on the other hand, might originate from the nerve root irritation, with a painful sensation extending to the leg (below the knee), generating a sharp, tingling pain.
According to Rubinstein7  the factors associated with the development and persistence of low back pain are often to be found among the following:
- a previous episode of low back pain, low job satisfaction or low pay
- inadequate ability to cope with stressful situations, avoidance behavior
- manual labor or physically stressful activities
- obesity, somatization, smoking
- low baseline physical activity, ongoing disputes, old age
- low levels of education, high intensity pain or disability,
- neurological symptoms, depressed mood, emotional distress, anxiety.

The dynamics of pain
The effects of poor mobility caused by a sedentary lifestyle create conditions similar to those occurring in normal degenerative aging processes. The condition of localized immobility (long periods spent in a sitting position, sometimes in an ergonomically incorrect posture) generates pain and progressive loss of function, which arises as a result of connective tissue adaptations at a shorter distance between the origin of the fiber and its insertion. A long immobilization period, in addition to generating a sudden degeneration of the connective tissue, determines:
- starting from the third week, the development of abnormal patterns between new and pre-existing collagen fibers, altered collagen turnover (synthesis/lysis), random arrangement of new collagen fibers within the pre-existing collagen tissue.8 Some authors9,10 have found that the temporary lack of mechanical stimuli (periods of relative immobility) generates adaptive structural changes which can hardly regress. These changes are related to the variations in the orientation of the connective tissue fibers, the quantity and quality of the amorphous ground substance (typical of the connective tissue) with a reduced concentration of water and glycosaminoglycans (GAGs), which results in a reduced interfibrillar lubrication, hence the formation of adhesions (loss of sliding capability) both at fiber–fiber interaction11,12  and between tendons and the surrounding connective tissue. The random arrangement of new collagen fibers in the existing tissue limits movement and alters the plasticity of the connective tissue.
The proliferation and sclerotization of the adipose tissue in the joint area are among those structural changes which occur during a period of little or inadequate movement, together with the limitation of the articular mobility, cartilage erosion and the formation of osteophytes. These structural changes are closely related to the amount of movement reduction, to the period of limited mobility, to the adaptive posture developed, to the contact surfaces and to the pressure distribution on the articular surfaces. The longer the period of limitation of the function, the longer it takes to restore the proper range of joint mobility.
Given the above premises, the data collected at the Functional Neurology Center, Osteolab (Benevento) on a sample of about 1200 patients observed between 2006 and 2011, with a study conducted on a further 1400 patients between 2012 and 2018, allowed us to determine that the lumbar pain mainly stems from a mechanical source and further develops in two distinct phases:
- a phase of preparation to the conflict, when the attempt to compensate for the changes in mechanical demands generates a functional overload of the neuromuscular tissues involved in order to maintain the postural alignment. This phase is characterized by neuromuscular structure suffering, specifically affecting the common lumbar muscle mass, the gluteus (primarily the gluteus medius), the biceps femoris, the vastus lateralis and the peroneus muscles. This condition is accompanied by a chronic state of fatigue and increased levels of psychophysical stress, maladaptive behaviors etc.;
- a phase of reaction to the conflict, when there is an attempt to balance the tensions resulting from the changed balance of forces caused by the functional overload of the neuromuscular tissues. This phase is characterized by a more or less widespread temperature reduction in the dermal region of interest (ilio-sacral joint) and stiffness of the involved tissue structures (mainly the gluteus medius, the vastus lateralis and the peroneus muscles). In this phase, the sclerotization of the connective tissue and changes in the muscular trophism occur, mainly affecting the lumbar and sacroiliac areas (where the lipomas are encapsulated, also known as Copeman nodules), also involving the gluteus medius and paraspinal interfaces.
These are the causes which trigger the onset of low back pain which – when is not caused by an established disease – evolves in relation to three degenerative levels (qualitative and not quantitative):
- Each case of low back pain is the result of an alteration of the mechanical function determined by limited mobility, originating from conflict counter-resistance (CCR) which is a sudden, unexpected, severe trauma occurring at muscle-tendon level, involving all the structures engaged in an activity, mainly in the extension phase.
- Every CCR causes stiffness in muscle-tendon joints affected, with a consequent functional limitation of the articular joints (sacroiliac, L5-S1, L4-L5).
- Each limited excursion of articular joints determines spinal disc strain (with or without protrusions, extrusions or degenerative phenomena) with potential reduction of the intervertebral space, possible constriction of the intervertebral foramen and consequent potential compression of the affected nerve root.

Objectives of the study
  1. Given the above considerations, in order to better understand the mechanisms behind low back pain, we identified the following objectives:
    1. Primary objective: define in what terms (quantitative and qualitative) the mechanical functional lesions influence the onset of back pain
    2. Secondary objective: define the “signs of hypotrophy” as biomarkers for motor dysfunction and record how much their presence affects the development of back pain
    3. Tertiary objective: test the effectiveness of the manual medicine in the resolution of motor dysfunction related to pain.

Definition of signs of hypotrophy
In the majority of people with low back pain there are potential biomarkers of the motor dysfunction. In the clinical phase, these are often overlooked in favor of likely asymptomatic disc lesions or hypothetical radicular alterations.
These biomarkers consist of one or more lipomas (cluster) that cause pain in the lower back and which are often revealed by alterations of the mechanical function while maintaining an erect posture, inextricably linked to alterations of muscular tropism in gluteus medius, tensor fasciae latae, iliotibial band, vastus lateralis, peroneus muscles and extensor digitorum longus of the foot, making it difficult to sit or to make any kind of movement.
This alteration has been described for the first time in 1937 by Ries as episacro-iliac lipoma, which requires a treatment based on injections of anesthetic or surgical excision. Later on, Copeman and Ackerman described it as “nodule” which consists of herniated adipose tissue along the neurovascular bundle, below the superficial fascia.13
At the ultrasound examination they appear as hypoechoic lesions of the subcutaneous tissue, well delimited in correspondence with the upper part of the iliac crest (in one or both sides), not vascularized.
The objective examination emphasizes:
- In the inspection phase: considerable reduction in the tropism (muscle mass), especially the gluteal structure; generally antalgic posture, with lumbar paravertebral muscles in a state of unilateral hypotrophy, especially in the acute phase of the alteration; lumbar spine tends to lose its physiological lordosis; pelvis misalignment with concurrent difficulty in walking; lumbar pain (in the affected segment) accentuated by lumbar spine movements (especially lateral flexion from the opposite side) and by the physical exertion.
- In the palpatory phase: nodular structures present along the iliac bone, which causes discomfort at palpation (hyperesthesia) or pain, localized or extended to the legs (iliotibial band, vastus lateralis and biceps femoris, extensor digitorum longus of the foot, peroneal muscles, extensor hallucis longus); fibrous paraspinal and gluteal muscles; deficit of sensitivity (numbness) or of the muscle function (obvious loss of strength).
In the lumbosacral area, as it has also been shown through dissection studies at the Université Bordeaux Segalen, this condition highlights two types of signs:
  • Lipoma structure (one or more per side), tapered in shape and variable in size (up to five centimeters in length; up to three centimeters wide), located along the edge of the iliac crest, unilaterally or bilaterally, encapsulated in rigid fibrotic tissue, relatively voluminous.
  • Pathological adhesion of the fibrous connective tissue, with the appearance of a sclerotic membrane covering the entire thoracolumbar fascia in its lumbo-sacral portion (with extension depending on the intensity and duration of the inflammatory process).

Materials and methods
In order to avoid any bias, we deliberately chose not to consider previously confirmed diagnosis nor instrumental tests conducted (such as therapies prescribed), but we decided to focus on the pain and its manifestations, the affected areas, the ability of contracting and/or moving the muscle groups involved, in order to maintain an erect posture or moving around.
For these reasons, the study was conducted as follows:
• Patient registration; each patient has been assigned an identification number.
• Collecting medical history, therapeutic procedure already practiced and current clinical situation;
• Evaluation of the functional lesions observed, marking among others
- SI1, as “Signs of Active Hypotrophy”;
- SI2, as “Signs of Silent Hypotrophy”;
• Recording of the functional alterations observed
- DL0 – low back pain;
- DL1 – pain with inability to move;
- DL2 – stabbing pain on the upper margin of the iliac crest, extended to the gluteus with inability to move;
- DL3 – stabbing pain, extended to the gluteus and leg (sharp pain on the lateral-posterior portion);
- DL4 – stabbing pain, extended to the gluteus, leg (sharp pain on the lateral-posterior portion) and thigh (dull)
• Devising a therapeutic procedure.
The proposal of an alternative model of pain assessment lays its foundation on the need to avoid an inconsistent diagnosis, or to create a relation between clinically detectable functional lesions, instrumentally recorded structural lesions (if any) and sensations manifested by the patient.

All the patients who had requested medical intervention aimed at the resolution of low back pain were admitted to the study, regardless of whether the pain was in an acute stage (started at least 3 days earlier), subacute stage (started more than four weeks earlier) or chronic stage (started more than twelve weeks earlier).
It is relevant to notice that, before entering the clinic, according to ordinary therapeutic practice:
• The doctor or the therapist recommended that every patient should have absolute rest, along with intake of non-steroidal anti-inflammatory drugs and, when necessary, cortisone;
• Generally speaking, drugs did not have any effect since the pain was evidently determined by mechanical causes (shifting of the center of gravity);
• The diagnostic procedure, often based on imaging, by only recording the “structural lesion” proved itself incapable of detecting the relation between the lesion itself and the manifested pain.
Previous therapies
  • 54 patients (29,9%) were subjected to tens cycles, tecar treatment, ultrasound and/or massage, combined with NSAIDs, muscle relaxants and cortisone.
  • 85 patients (46,9%) had taken over the counter drugs to self-medicate.
  • 42 patients (23,2%) did not use drugs.
Diagnosis at presentation
  • in 147 (80.1%), forms of discopathy
  • in 103 (56,5%), sciatica
  • in 51 (28%), spinal canal stenosis
  • in 37 (20,3%), radicular compressions
  • in 8 (4.3%), forms of spondylolysis
  • in 7 (3,8%), spondylitis
  • in 6 (3.2%), colitis
  • in 6 (3.2%), renal colics
  • in 5 (2.7%), vertebral collapses
  • in 3 (1,6%), prostatitis
  • in 3 (1,6%), alteration in urinary function
  • in 2 (1,1%), spondylodiscitis
  • in 1 (0,5%), appendicitis
  • in 1 (0,5%), biliary colics
  • in 1 (0,5%), spina bifida
  • in 1 (0,5%), cauda equine syndrome
  • in 1 (0,5%), colon cancer
  • in 1 (0,5%), prostate cancer
  • in 1 (0,5%), seizure

The usefulness of diagnostic imaging is limited by the high prevalence of degenerative diseases in asymptomatic adults. About 30% of asymptomatic subjects present with a disc protrusion on MRI, more than half of the subjects present with bulging or degenerated intervertebral disc, one fifth present with herniated annular fissures.14
After having excluded other serious causes through the differential diagnosis, the physical examination (aimed at finding physical signs which were subjective for every patient according to their specific conditions) allowed us to identify triggering factors and structures responsible for the alteration, which in turn caused the pain. In many admitted patients, sensory abnormalities were recorded, along with apparent neurological weakness, antalgic or avoidance gait, decreased or no reflexes in the ankle and knee.

Common clinical evidence
The clinical evaluation has highlighted several elements common to all the treated patients:
1. At orthostatic examination it was recorded:
- a general poor distribution of loads on the plantar surface;
- asymmetric of foot position
- functional collapse of one (or both) the calcaneal axes;
- internal rotation of the tibias (with an uneven increase of the volume and tone of the extensor digitorum longus muscle, peroneal muscles and tibial);
- asymmetric valgus deformity of the knees;
- asymmetric internal rotation of the knees (with or without recurvatum);
- mechanical and functional alterations of the pelvis (inclination, slippage, rotation, anterior/posterior pelvic tilt);
- adaptive alteration of the physiological curves of the spine;
- shoulders misalignment.
2. The palpation exam, using different specific tests depending on the patients’ conditions (such as Lasègue, Wasserman, Valsava, Bragard, Thomsen, Yeoman, Bonnet e Hoover) proved to be useless, since the tests were not accurate enough and widely open to interpretation, therefore considered as not very reliable. Moreover, it was frequently recorded:
- reduced specific mobility, often conditioned by functional impairment and pain tolerance;
- stiffness in the left side of the leg (likely affecting the peroneus longus, the peroneus brevis and the extensor digitorum longus) or the posterior compartment of the thigh (likely affecting the biceps femoris muscle and vastus lateralis) and/or the gluteus (likely affecting the gluteus medius and the gluteus maximus across the sacroiliac joint);
- pain (often a burning pain) in the posterior external malleolus area, in the peroneus brevis muscle and/or in the iliac insertion of the gluteus maximus/medius.
After assessing the range of mobility, the main obstacle seems to be the functional impairment and the levels of pain perception.
The palpation of the various vertebral segments proved to be useless in the identification of the alterations presented by the patients. The palpation of the different areas affected by the pain allowed us to confirm the presence and the responsiveness of the “signs of hypotrophy”, which consisted of:
- Hypotrophy Sign 1: lipoma structure, located along the edge of the iliac crest, unilaterally or bilaterally (a condition depending on the characteristics of the alteration in place). Fibrotic, rigid, voluminous and symptomatic, causes the patient to manifest symptoms ascribable to low back pain, with a burning (stabbing) pain.
- Hypotrophy Sign 2: pathological adhesion of the fibrous connective tissue, with extension linked to the intensity and duration of the inflammatory process. Fibrotic and rigid, causes the patient to manifest symptoms ascribable to low back pain, with burning pain (extensive).

Interventional procedure
Traditionally, in treating low back pain two different approaches are adopted:
• Conservative: it’s the first one to be considered for any condition (whether it is acute, subacute or chronic). In the acute and subacute phase, the conservative treatment has the purpose of reducing the symptoms, prevent relapses, reduce the disability and the risk of chronicity. The protocols adopted by the health care system dictate that, in case of chronic low back pain, there should be made a distinction between symptomatic intervention (pharmacological and instrumental) and therapeutic functional rehabilitation (both physical and manual therapy). In this case, it is necessary to quantify the difficulties patients encounter in their everyday life, with a series of multidisciplinary interventions. The conservative treatment with anti-inflammatory drugs and muscle-relaxants drugs, or instrumental therapies, proved to be often useful solely to control the pain. In the guidelines published in conjunction by the American College of Physicians and the American Pain Society (2007), there is solid evidence supporting the manual therapy for low back pain, especially in the subacute phase (more than four weeks) and chronic phase (more than twelve weeks).
• Non conservative (surgical), taken into consideration only when the conservative treatment proves to be ineffective, with severe neurological deficit.
In a conservative setting and aiming for a functional rehabilitation therapy, after evaluating their initial conditions, we allocated the patients to three treatment arms, established on the bases of their therapeutic needs:
• Arm A, primary - manual therapy (osteopathy and chiropractic)
• Arm B, integrative (if any) - proprioceptive therapy
• Arm C, integrative (if any) – kinesitherapy (rehabilitation of motor function)
The therapeutic process was structured as follows:
• Manual Therapy (MT): all the patients have been treated with a number of sessions (a weekly treatment session, on average) and various techniques defined according to the different needs manifested in time (patient’s current physical and health conditions) with follow-up seven days after the end of the last treatment.
• Proprioceptive Therapy (PT): where necessary, patients have been subjected to postural evaluation in order to define the structural asymmetries and functional imbalances. As a result, patients were supplied with proprioceptive insoles in order to balance the weight distribution on the plantar surface.
• Kinesitherapy (K): where necessary, patients were subjected to muscle testing aimed at assessing the balance and motor coordination skills, the execution of a specific motor gesture and strength expression. An elaborate plan aimed at correcting the motor function was devised for each patient.
The intervention protocol did not require use of drugs. The manual therapy techniques have been borrowed from the osteopathic structural and chiropractic literature, suitably combined with each other. The home therapy prescribed consisted of using heat sources (bandages, heating pads or heating ointments) to be applied locally, conveniently combined with suitable (concentric) rehabilitation exercises or unloading exercises and stretching.

Definition of manual therapy procedure
Different techniques were chosen depending on the general conditions of the patient, the manifested symptoms, the functional alterations recorded, etc.
Provided that mobilization techniques must be used when there is the necessity and the opportunity (adjusted according to the patient’s feedback, to the established therapeutic tier and to the clinical experience of the healthcare operator), in treating low back pain disorders it can be useful taking into consideration different stages of intervention: the appropriate degree, range of motion, strength, direction, speed and duration, suitable to achieve the treatment specific goals.9  
The established procedure for the patients admitted to the study consisted in two main parts:
• neuro-muscular and connective phase, aimed at reducing tissue stiffness, improving its function. Slow, progressive and prolonged tissue mobilization, with delicate but firm movements, not necessarily following the fiber direction, combined (when needed) with ischemic pressures, are aimed at:
- restoring tissue mobility safeguarding the physiological tissue movement (treating adherence-related problems);
- producing local hyperemia to reduce the pain and regulate the flow of substrates and metabolites (eliminating inflammatory toxins);
- orientating collagen fibers in the most appropriate direction, in order to enhance the resistance to mechanical loads (increased tissue elasticity);
- stimulating the mechanoreceptors in order to inhibit afferent nociceptive messages (elimination of pain).

Studies conducted by Warren et al (1971) demonstrated that the combined application of heat and load on the tendon, which deeply influence the properties of the viscous flow of the collagen, was able to determine an elongation of the tissue, with low incidence of microlesions (directly proportional to the selected temperature). The raise of the local temperature between 40 and 45 degrees determines a thermic effect similar to that obtained with ultrasound, which act selectively by heating the collagen tissue.

• Articular phase, which first consisted in reaching a non-painful arc of movement performed with a certain mechanical strength in order to stimulate the orientation of collagen fibers (increased agitation of the tissue fluid, prevention or resolution of adhesions between fibers, longitudinal stretching, restoration of normal function, reduction of potential loose bodies); then, patients were assisted to achieve maximum range of motion (functional barrier), maintaining the position for a few seconds, in order to determine the permanent elongation of collagen (interruption of the capsular adhesions, reduction of pain and improvement in function). Ultimately, a maneuver of minimum range and maximum speed is performed at the end of the arc of movement (structural barrier) in order to unlock the joint, reducing the intra-articular displacement, eliminating the condition of compression and hyperpressure (interruption of peripheral adhesions), therefore eliminating the presence of any risk factor and restoring a complete and painless function.

The statistical data collected through the present observational study, in addition to demonstrating the validity of the protocol and the effectiveness of the techniques, has shown a significant reduction in the initial symptoms (t = 84.354, p<.0001). Of the 182 evaluated patients (100 males and 82 females), it has been recorded an average of:
• 23,3 days of pain before seeking treatment
• 8,25 pain score for incoming patients
• 0,3 pain score for discharged patients
• 1,4 therapy sessions needed to restore function.

Classification of pain
• 62 cases (34%), of which 16 with SI1 (25,8%) were classified as DL0 (pain in the lumbar area) and treated with
- 1 session in 59 cases
- 2 sessions in 3 cases
• 76 cases (41%), of which 39 with SI1 (51,3%) were classified as DL1 (pain in the lumbar area, with inability to move) and treated with
- 1 session in 64 cases
- 2 sessions in 10 cases
- 3 sessions in 2 cases
• 19 cases (10%), of which 13 with SI1 (68,4%) were classified as DL2 (lumbar pain extended to the gluteus with inability to move) and treated with
- 1 session in 7 cases
- 2 sessions in 10 cases
- 3 sessions in 2 cases
• 14 cases (7%), of which 9 with SI1 (64,2%) were classified as DL3 (lumbar pain, extended to the gluteus and leg, in the lateral posterior portion) and treated with
- 1 session in 1 case
- 2 sessions in 8 cases
- 3 sessions in 4 cases
- 5 sessions in 1 case
• 11 cases (6%), of which 9 with SI1 (81,8%) were classified as DL4 (lumbar pain, extended to the gluteus, leg and thigh, in the lateral posterior portion) and treated with
- 2 sessions in 1 case
- 3 sessions in 5 cases
- 4 sessions in 5 cases

Focal lesions
• 86 cases out of 182 (47,2%) showed the presence of SI1 (active)
- 9 cases (10,4%) with DL4
- 9 cases (10,4%) with DL3
- 13 cases (15,2%) with DL2
- 39 cases (45,4%) with DL1
- 16 cases (18,6%) with DL0
• 42 cases out of 182 (23,1%) showed the presence of SI2 (silent)
- 24 cases (57,2%) with DL0
- 16 cases (38,2%) with DL1
- 1 case (2,3%) with DL2
- 1 case (2,3%) with DL3
• 25 cases out of 182 (13,7%) showed a Facet Joint Syndrome with spontaneous spinal pain
- 6 cases (24%), D12/L1 segment
- 7 cases (28%), L2/L3 segment
- 10 cases (40%), L3/L4 segment
- 2 cases (8%), L4/L5 segment

Integrative therapy
• In 22 cases (12,1%) it was decided to start a rehabilitation program for motor function
• In 40 cases (21,9%) it was decided to start a procedure to restore proper arch alignment and muscle proprioceptive activation
• In 120 cases (66%) it was not deemed necessary

Effectiveness of the intervention protocol
• 133 cases (73,1%) recovered full function, without pain
- 85 cases (62,9%) with one treatment session
- 40 cases (30,1%) with 2 sessions
- 7 cases (5,4%) with 3 sessions
- 2 cases (1,6%) with 4 sessions
• 24 cases (13,3%) recovered full function, although maintaining some forms of muscular stiffness
- 12 cases (50%) in the lower limbs
- 5 cases (20,8%) in the knee flexors
- 5 cases (20,8%) in the lumbar area
- 2 cases (8,4%) in the semitendinosus and semimembranosus
• 29 cases (15,9%) of fatigue that, in 12 cases (41,3%), was clearly manifested in the lower limbs
• 5 cases (2,7%) of soreness

The present study highlights how dominant the “ascending” mechanical cause is, compared to any other hypothesis (discopathy, radicular compression, etc.) which only represent the natural consequence of the mechanical cause. The shape and the spatial organization of the body (erect posture), both in static and dynamic phase, are the result of continuous compromises (balance) that the body reaches with the surrounding environment and are maintained through the persistent contraction (postural tone) of muscle groups (vertical stabilization system - Karl Lewit). These muscle groups’ main function, which is used in ascension through feedforward and feedback mechanisms, is that of opposing gravity. Mechanical alterations or structural asymmetries which cause the pain, represent the breaking of that initial compromise: all conditions of hypotrophy and/or unilateral chronic stiffness of dynamic paired muscles, which cause pelvic misalignment, originate from alterations in the vertical stabilization system (postural alteration). The permanence in the state of alteration determines a parenchymal damage which exacerbates the pain sensation.
The observations on the etiology of back pain highlight how unlikely is that back pain is caused by discopathy or spinal canal stenosis. Regardless of the determined diagnosis, every case we studied has showed more or less relevant alterations related to the mechanical function of feet and lower limbs, with inevitable consequences on spine and pelvis balance. In particular, the state of alteration was related to the tone of the muscles directly involved in the plantar arch structure, in the tibia and femur alignment, in the pelvis balance and in the physiological curvature of the spine. As a matter of fact, it was easy to detect cases of functional collapse of the arches, internal rotation of the knees, misaligned pelvis and loss of physiological curvature of the spine. It was clear that the aching muscle groups were those more closely involved in the alteration (back stabilizer muscles, extensor digitorum longus muscle, peroneal, tibial, vastus lateralis, tensor fasciae latae, gluteus medius), causing the pain. In no case signs of neuropathic pain (painful nerve block) or radicular pain (metameric pain) have been observed. Therefore, it is believed that – when present – forms of spinal disc problems (dehydration, protrusion, herniation and extrusion) are always to be considered not as the “cause of pain” but as simple “consequences” of a mechanical alteration: the vertebral column adaptation to the uneven pressure on the feet and lower limbs lays the groundwork for a gradual loss in the physiological curves, exposing the discs to a progressive increase of the vertical loads.
It is no coincidence, in fact, that the pain usually appears in the proximity of the sacroiliac region first, extended to the lateral portion of the gluteus, aggravating the symptoms by involving peroneal muscles, extensor digitorum longus and, only ultimately, the upper thigh with tensor fasciae latae, biceps femoris and vastus lateralis.
Given the recurring posterior pelvic tilt and the consequent adaptation of the rachis (verticalization), the soreness determined by a prolonged sitting position and/or by forward flexion of the trunk, is not ascribable to discopathy or stenosis of the spinal canal, but it simply is the expression of the inability of the lumbar muscles to withstand the stress generated by incorrect posture. Moreover, considering the fact that the spinal cord compression (stenosis) cannot produce pain but, at most, an extrasegmental reference of paresthesia 14,15, muscle weakness with spastic gait (upper motor neuron lesion) and extensor plantar reflex, it is easier to feel a (burning) pain, loss of sensation and tingling as consequences of a chronic stiffness on a specific muscle group in a condition of functional impairment (because of the constriction and vasoconstriction).  
In the light of the examined data, it is clear that signs of hypotrophy play a primary role not only in the exacerbation of the pain sensation, but also in the motor limitation which consequently arises. Their presence has been registered in various capacities in 127 cases (69,8%):
- 86 active cases causing pain, of which 52 (39 in DL1 and 13 in DL2) manifested directly in the phase of movement limitation
- 42 silent cases, possible consequence of previous alterations now compensated but not necessarily resolved. Mainly present in low back pain (24 in DL0 and 16 in DL1), their tissue appears to be sclerotic, apparently asymptomatic, although painful to the touch. The observation conducted on approximately 2400 patients in the period from 2006 to 2018, has allowed us to verify the absolute capability to increase volume, stiffness and soreness.
In is interesting to notice that, the larger the area in state of alteration, the greater the percentage of presence of SI1:
- 25,8% of DL0 (16 of 62)
- 51,3% of DL1 (39 of 76)
- 68,4% of DL2 (13 of 19)
- 64,2% of DL3 (9 of 14)
- 81,1% of DL4 (9 of 11)
Given the above considerations, the hypothesis of defining these signs as biomarkers of motor dysfunction can certainly be confirmed. Deepening the knowledge about them can help to prevent the onset of pain or allow the formulation of an adequate program of functional recovery, therefore avoiding unnecessary, expensive, unpleasant and often harmful pharmacological protocols, sometimes combined with equally inadequate protocols of physical and instrumental therapy.
Although painful for the patient and difficult for the therapist, the practice of manipulative therapy proved to be extremely useful in treating acute or chronic lesions.
The neuromuscular intervention is aimed at producing mechanical hyperemia (possible increase in inflammation), causing the vasodilation of the skin and deep tissues, facilitating the elimination of inflammatory substances. Assuming that the viscoelastic structures possess sliding and hysteresis properties (ability to react to a stimulation), the application of an adequate force exploits the phenomenon of the viscous flow in the connective tissue structures.
Specific maneuvers have been performed on all the patients with physiological limitations of vertebral movements, which are generally associated with spontaneous vertebral pain and segmental symptoms (25 cases accounting for 13,7% of the cohort), even in acute inflammatory phase. The maneuvers that have been directly performed on the areas affected by the lesion, allowed an immediate restoration of the joint excursion capacity, with consequent improvement of the reported painful symptoms. Moreover, the repeated movement (typical of the mobilization) and the rapid manipulative gesture, have also been effective on the intrinsic paravertebral muscles, thus relieving joint tension occurring when the joint is led to the maximum range of excursion, with or without the final thrust movement (crucial in 25 cases, accounting for 13,7% of the patients).
From the observation of the data collected in the present study, it is evident that:
- 133 patients achieved a full recovery;
- 24 patients achieved an optimal recovery although still showing some forms of muscular stiffness;
- 29 patients achieved a good recovery with forms of muscle fatigue;
- 5 patients achieved a good recovery, though still presenting with forms of soreness.
In the authors’ opinion, differently from what was stated in practical guidelines published in conjunction by the American College of Physicians and the American Pain Society in 2007 (mentioning only a few good evidence supporting manual therapy for low back pain in the subacute and chronic phase), not only it is possible to achieve a full recovery of functional mobility in total absence of pain in the acute phase (achieved in 106 cases out of 182, accounting for 57,7% of patients), but the results of the study go far beyond “a few good evidence” even when considering subacute and chronic phases (of 76 cases out of 182, only 5 patients - 2,7% - have manifested soreness at follow-up). In order to structuring a truly valid and effective protocol, it is surely decisive to classify patients according to the type of pain manifested.

Conflict of interests
The authors certify the study was conducted without conflicts of interest.
31st October 2021
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