Suggested Guideline

Suggested Guideline:

The non-surgical management of chronic low back pain.

Dr Corrie Avenant M.B.Ch.B (Stell) DA (SA) FCA/GKN (SA)

Summary

These guidelines for the management of low back pain give a comprehensive picture. They begin with an analysis of the structure basis and etiology of low back pain. Information is then given on diagnostic techniques and treatment approaches for different types of low back pain. Detailed evidence of the effectiveness of a variety of treatments is provided, taken from a wide variety of studies. The information is summarised in two useful algorithms and a diagram illustrating the multidisciplinary approach to the management of low back pain.

  1. 1. Structural Basis:

For a structure to cause pain, it must fit the following description:

  • It should have a nerve supply;
  • It should be susceptible to disease or injuries that are known to be painful;
  • It should have been shown to be a source of pain in patients, using diagnostic techniques of known reliability and validity.

By using controlled, comparative, and double diagnostic blocks, it has been established that lower back pain is of the following types:

  • 40% is facet joint pain;
  • 26% is discogenic pain;
  • 2% is sacro-iliac joint pain;
  • 13% is segmental dural/nerve root pain;
  • 13% is unknown.

The causes of these types of low back pain are as follows:

  • Facet Joint Pain:

Studies involving controlled diagnostic blocks of facet joints have demonstrated that facet joints are implicated in spinal pain for 45% of patients with low back pain.

  • Intervertebral Discs:

In 1934, Mixter and Barr described the disc as a source of pain.

In a controlled study, Schwarzer found that the low back pain of 39% of chronic sufferers was due to internal disc disruption.

  • Dorsal Root Ganglion:

The Dorsal Root Ganglion plays an important role in the mechanism of spinal pain.

Experiments suggest that when DRG is injured, oedema in the dorsal root ganglion underlies the production of nerve root pain in patients with disc herniation.

  • Sacro-Iliac Joint:

The Sacro-Iliac Joint is well innervated, fed by myelinated and unmyelinated axons capable of nociception.

In studies utilising controlled, comparative local anaesthetic blocks in patients with low back pain in whom there was a high index of suspicion for pathology, the prevalence of sacro-iliac joint dysfunction was established as 18.5%.

A high prevalence of pain caused in this way may be seen in patients with lumbar fusion.

  • Post-Laminectomy Syndrome (FBSS):

The term ‘Failed Back Surgery Syndrome’ is used to describe a cluster of syndromes resulting from surgery where the expectations of the patients and spine surgeon have not been met.

  • Etiologies:

The etiologies of low back pain are summarised as follows:

  1. Surgical:
  • Stenosis
  1. Disc Disruption:
  • Recurrent disc herniation
  • Retained disc fragment
  • Spondylolisthesis
  1. Non-Surgical:
  • Epidural or intraneural fibrosis
  • Degenerative disc disease
  • Radicular pain
  • Facet joint pain
  • Sacro-iliac joint pian
  • Discitis
  • Arachoniditis

Note: Epidural fibrosis is caused by FBSS in up to 36% of all cases.

  1. Other:
  • Facet joint arthritis
  • Incomplete (or inaccurate) surgical intervention
  • Fibromyalgia
  • Myofascial syndrome

Certain of these etiologies can be treated by interventional pain methods. E.g. epidural fibrosis, facet joint dysfunction, internal disc dysfunction, recurrent disc herniation, spinal stenosis.

Spinal Stenosis:

Narrowing of the spinal canal resulting in:

  • Symptoms and signs caused by entrapment and compression of intra-spinal vascular and nervous structures.

The causes of narrowing of the spinal canal are:

  • Disc bulging, protrusion and herniation
  • Osteophytes and arthritic changes of facet joints

Treatment options for Spinal Stenosis are as follows:

  • Surgery
  • Non-operative:
    • Conservative Rx
    • Interventional techniques
  1. Diagnosis

2.1  Clinical examination:

Purposes

The purposes of exploring the history of the condition, and of physical examination and special investigations are to:

a)      Determine “red flag” conditions, e.g.

  • Tumours;
  • Fractures;
  • Progressive Neurological outfall;

b)      Determine if lower back pain is of mechanical (nociceptive) or neurogenic (neuropathic) origin.

The following table outlines the differences between Radicular Pain and Somatic Referred Pain.

Feature: Radicular Pain: Somatic Referred Pain:
Distribution Entire Length of lower limb BUT Below Knee > above knee narrow band travelling Traveling proximal > distal Wide Area Relatively fixed in location
Quality Shooting, lancinating, like electric shoc Dull, aching, like an expanding pressure
Depth Depp as well as superficial radiofrequency Deep only, lacks any cutaneos quality

MRI is the primary diagnostic imaging of choice. The indications for further diagnostic testing are:

  • Foot drop
  • Progressive weakness
  • Fever
  • Unexplained weight loss
  • Change in bladder or bowl function
  • Persistence or worsening of symptoms beyond 6 weeks

From this information a decision is made on the proper treatment.

2.2  Diagnostic Blocks:

Diagnostic blocks are used to diagnose in cases of low back pain. This is because most of the manoeuvres in physical examination place stress on several structures simultaneously, making it difficult for a conclusive diagnosis to be reached.

It must be acknowledged, however, that the accuracy of diagnoses based on these blocks cannot always be relied upon, as they vary in sensitivity, specificity, accuracy and quality. False positives, negatives and the placebo effect can be exacerbate the difficulties of diagnosis.

Types of Diagnostic Block

Evidence-based diagnostic blocks for lower back pain include:

  1. Facet (Zygapophysial) Blocks
  2. Provocative Discography
  3. Transforaminal Epidurals
  4. SI Joint Infiltrations

Mechanisms of Neural Blockades

The postulate mechanism of a neural blockade is that it alters or interrupts nociceptive pain.

It does by:

a)      Local Anaesthetic which interrupts the pain spasm cycle, dampening the C-fibre activity.

b)      Corticosteriods which reduce the inflammation by inhibiting synthesis or release of pro-inflammatory substances. The methods of Corticosteriods actions are:

  • Membrane stabilisation
  • Inhibition of nearal peptide synthesis
  • Blockade of Phospholipase A2
  • Suppresion of sensitisation of dorsal horn neurons

Detail with regard to each type of diagnostic block follows below:

  1. Facet (Zygapophysial) Blocks

For Facet (Zygapophysial) joint pain, controlled diagnostic blocks with tweo different Local Anaesthetics are the only means to confirm the diagnosis.

  1. Provocative Discography

Provocative discography is a procedure that characterises the patho-anatomy of the intervertebral disc and thereby enables the physician to determine whether the disc is the source of the pain. The discography of normal discs is never painful.

Discography has high accuracy rates, and is important in ensuring that informed decisions are made.

  1. Transforaminal Epidurals

The diagnostic selective nerve root block (Transforaminal Epidural) is indicated:

  • Where a patient has persistent pain;When neither history, examination, imaging and other precision diagnostic injections, nor electrophysiological testing identify the pain generator.
  • Where the patient presents with radicular pain.

Sensitivity to this diagnostic block can be as much as 100%.

  1. SI Joint Infiltration

No history, examination, manpower or radiological feature can enable a definite diagnosis of SI Joint Pain.

  1. Levels of Evidence:

A wide range of evidence is presented in the following section, indicating the effectiveness of a variety of treatment systems.

Criteria of the studies included in these guidelines were gathered from the Agency for Healthcare Research & Quality (AHRQ) and the Cochrane Review.

Different types of evidence have been included:

  • Systematic Reviews;
  • Randomised Clinical Trials;
  • Observational Studies;
  • Diagnostic Studies.

If randomised trials were not available for a particular procedure/technique, non-randomised trials or observational studies have been used.

The different levels of evidence are:

Level I:

  • Conclusive: Research-based evidence from multiple relevant and high quality scientific studies;

Level II:

  • Strong: Research-based evidence from at least one properly designated randomised, controlled trial of appropriate size (with at least 60 patients in the smallest group);

Level III:

  • Moderate: Evidence from a well-designed small-randomised trial or evidence from well-designated trials without randomisation;

Level IV:

  • Limited: Evidence from well-designed non-experimental studies from more than one centre or research group;

Level V:

  • Intermediate: Opinions of respected authorities, based on clinical evidence, descriptive studies, or reports of expert committees.
  1. Treatment Options:

Treatment needs to be provided in a compassionate, co-ordinated fashion that addresses the multidimensional needs of the individual. For patients with extensive pain or disability, multidisciplinary care is essential, to optimise a positive and functional outcome.

The team approach should focus on all the following therapies:

  • Counselling
  • Social work
  • Physical therapy
  • Cognitive behavioural psychology
  • Multidisciplinary management
  • Pharmacotherapy
  • Occupational therapy
  • Vocational therapy

4.1  Non-Pharmacologic Management

This includes:

  • Exercise (strengthening exercises, walking, bicycling and swimming). Ideally exercise should be incorporated into a home programme that becomes part of an on-going lifestyle.
  • Education of the sufferer towards protection of the spine during the normal activities of daily living.

Treatment goals include:

  • Preventing symptoms, if possible;
  • Reducing pain severity or frequency;
  • Improving physical functioning;
  • Reducing psychological distress;
  • Improving overall quality of life;
  • Minimising possible adverse effects of treatment.

4.2  Pharmacological Management:

Nociceptive Pain

For Nociceptive pain, anti-inflammatory agents are the basis of treatment.

Neuropathic Pain

Most evidence for neuropathic pain treatment is derived from diabetic neuropathy and postherpetic neuralgia.

First line drugs include:

  • Gabapentin;
  • Tricyclic antidepressants;
  • Opiods.

This will be discussed under the subject “Protocols for neuropathic pain”.

4.3  Therapeutic Blocks:

  1. 5. The time period for therapeutic cortisone block is seen as:
  • Short Term: Less than 6 weeks
  • Long Term:
  • Longer than 6 weeks

For the ablation techniques, short term and long term may be defined as:

  • Short Term: Less than 3 months
  • Long Term: Longer than 3 months

4.3.1        Intra-Articular: Zygapophysical Blocks:

The evidence for intra-articular injections is indicated on the table below:

Methodological Quality Score(s): Initial Relief: Long-term Relief: Results:

StudyStudy CharacteristicsAHRQ Score(s)Cochrane Score(s)No. Patients<6 Weeks3 Mnths6 mnthsShort-Term < 6 WeeksLong-Term Relief > 6 weeksManchick antietal (483) 49RA8/106/1073100%100%82%PP

RA=randomised; P=positive; N=negative

Summary:

Moderate evidence for relief in the short term has been proven.

Limited evidence for relief in the long term has been proven.

4.3.2        Median Branch:

The following table shows evidence for the effectiveness of Cortisone Median Nerve Blocks:

Study Study Characteristics Methodological Quality Score(s): No. Pts: Initial Relief: Long Term relief Results:
AHRQ Score(s): Chochrane Score(s): <6 Weeks: 3 Mnths: 6 Mnths: Short-term <6 Weeks: Long-term > 6 Weeks:
Lumbar Spine:
Van Kleef Et al 50 PC,RA,DB 9/10 7/10 C=16 T=15 38% va 67% 19% vs47% 13% vs 47% P P
Dreyfuse et al 51 P 8/8 15 93% 87% 87% P P
Schofferman and Kine 52 R 8/8 12 83% 83% 83% P P
Schacrer 53 R 7/8 117 NS NA 68% N N
Tzaan and Tasker R 6/8 90 NA 41$ NA N N
North et al 55 R 7/8 42 45% 45% 45% N N
Vad et al 56 P 8/8 * 12 83% 83% 83% P P

R=Retrospective; P=Prospective; RA=Randomized; PC=Placebo Controlled; DB=Double Blind; C=Control; T=Treatment; N/A= Not available; P=Positive; N=Negative; LA=Local Anaesthetic; RADIOFREQENCYTN=Radiofrequency Neurotomy

Summary:

Evidence of relief is moderate.

4.3.3        Median Branch Neurotomy:

Two types of Radiofrequency

There are two types of radiofrequency which can be used:

  1. Conventional or Continuous:
  • The temperature is less than 45∞C and more. At these temperatures nerve damage takes place.
  1. Pulsed Radiofrequency:
  • As the temperature is less than 45∞C, tissue does not coagulate further. The heat which is generated is dissipated between pulses. Only transient inhibition of evolved synaptic activity takes place.

The mechanism of action:

  1. With pulsed Radiofrequency, the mechanism is definitely not heat. It is suggested that the electrical field rather than the temperature induces change in the nerve cells and has a Neuromodulatery effect on the pain procession mechanism.
  2. Recently, s new theory of mechanism was published by van Zandert. He compared C-fos in pulsed Conventional Pulsed Radiofrequency and Sham groups. Under normal circumstances, the exposure of culture cells to an electric field leads to the up-regulation of C-fos. He found that Pulsed Radiofrequency and conventional Radiofrequency lead to similar increases in C-fos.
  3. The persistence of expression of C-fos for 7 days and longer after Radiofrequency (exceeding the length of time of C-fos exprexxion caused by effects of surgery) seems to be evidence of sustained activation of the pain-inhibitory mechanism.

Evidence:

The evidence of trials of Medial Branch Neurotomy ( Percutamous Radiofrequency) is as follows:

Methodological Quality Score(s): Initial Relief: Long-term Relief: Results:

StudyStudy CharacteristicsAHRQ Score(s)Cochrane Score(s)No. Patients<6 Weeks3 Mnths6 mnthsShort-Term < 6 WeeksLong-Term Relief > 6 weeksBreivik et alRA, DB8/107/10C=19 T=1625% vs 67%19% vs 63%20% vs 50%PPBush and Hillier 59RA, Db8/108/10C=11 T=12100%NA64% vs 83%PNMatthews et al 60RA/DB8/1

7/10C=34 T=2356% vs 67%SMPRNANPHelsa and Breivic 61RA /DB7/107/1069 crossoverNANA59% vs 25%PPRevel et al 62RA7/106/10Forceful Inj-29 Regular=31NANA49% vs 19%PNMeadeh et al 63RA6/106/10D=16 D+G=15 G=16NANANANNMcGreggor 60RA6/105/10Caudal=14 Interluminar=16NANANANN

P=prospective; RA=randomised; PC=placebo controlled; DB=double blind; C=control; T=treatment; N/A=not available; P=positive; N=negative; ND=Negative Discography; PD=Positive Discography; D=Disruption; G=Glucocorticoid

Summary:

Evidence for short and long term is strong.

4.3.4        SI Joint:

Therapeutic injections which can be used for Sacro-Iliac Joint pain are:

a)      Intra-articular injection

b)      Percutaneous Radiofrequency

Evidence:

a)      The evidence of trials of the intr-articular injection is as follows:

Study Study Characteristics Methodological Quality Score(s): No. Pts: Initial Relief: Long Term relief Results:
AHRQ Score(s): Chochrane Score(s): <6 Weeks: 3 Mnths: 6 Mnths: Short-term <6 Weeks: Long-term > 6 Weeks:
Maugars et al 63 RA 6/10 6/10 10 pts / 13w/articulations 62% 62% 58% P P
Hanly et al 66 P 5/8 19 SI SI NI P N
Slipman et al 67 R 6/8 31 P N/A N/A P P

P=prospective; R=retrospective; RA=randomised; SI=significant improvement; NI=no improvement; NA=not available; P=positive; N=negative

Summary:

Evidence is moderate for short term and limited for long term.

Evidence:

b)      The evidence of trials of the Percutaneous Radiofrequency is as follows:

Study Study Characteristics Methodological Quality Score(s): Initial Relief: Long Term relief Results:
AHRQ Score(s): No. Pts: <3 Mnths: 3 Mnths: 6 Mnths: 1 Year Short-term <6 Weeks: Long-term > 6 Weeks:
Yin et al 68 R 4/8 14 64% 64% 64% 54% P P
Ferrante et al 69 R 4/8 33 35% 35% 35% NA N N
Cohen and Abdi 70 E 4/8 9 89% 89% 89% NA P P

R=retrospective; NA=not available; P=positive; N=negative

Summary:

The evidence is undermined.

4.3.5        Intradiscal Electrothermal Therapy (IDET):

IDET is a minimally invasive interventional technique to achieve disc decompression. It is performed by introducing a flexible catheter (containing a resistive coil) into the disc.

Evidence:

The evidence from trials of the Intradiscal Electrothermal Therapy (IDET) is as follows:

Study: Study Characteristics Methodological Quality Score(s): No. Pts: Initial Relief: Long Term relief Results:
AHRQ Score(s): Chochrane Score(s): <6 Mnths: 6 Mnths: 1 Year: Short-term <6 Mnths: Long-term > 6 Mnths:
Pauza el al 71 RA, DB, PC 10/10 10/10 C=27 T=37 Equal 50% Treat NA P N
Karasek & Bogduk et al 72 P 9/10 58 SI SI SI P P
Saal and Saal 73 P 6/10 58 SI SI SI P P
Gerszten et al 74 P 6/10 27 75% 75% 75% P P
Mekhall and Kapural 75 P 5/10 32 SI SI Si P P
Lee et al 76 P 5/10 62 53% 53% 53% P P
Luze et al 77 P 5/10 33 SI SI SI P P
Freedman et al 78 P 6/10 36 NA 47% 16% N N
Spruit 79 P 5/10 20 NSI NSI NSI N N
Derby et al 80 R 5/10 99 64% 64% 64% P P

P=prospective; PC=placebo control; RA=randomised; R=retrospective; C=control; T=treatment; SI=significant improvement; NA=not available; NSI=significant improvement; P=positive; N=negative

Summary:

Evidence is strong for the short term and moderate for the long term.

4.3.6.      Transforaminal Injections:

Transforaminal injections with cortisone can be used as a therapeutic technique.

Evidence:

The evidence from trials of the Transforminal injection is as follows:

Study Study Characteristics Methodological Quality Score(s) No Pts Initial Relief Long Term Relief Resutls
AHRQ Score(s) Cochrane Score(s) <6 Weeks 3Mnths 6Mnths Short Term < 6 Weeks Long Term Relief >6 Weeks
Riew et al RA, DB 8/10 7/10 IA=27 La=S=28 33% vs 77% 33% vs 77% 33%vs 77% P P
Karppinen et al RA, DB, PC 9/10 8/10 C=80 T=80 NA NA NA N N
Devulder et al RA 6/10 5/10 60 NS NS NS N N
Vad et al RA 7/10 7/10 48 48% vs 84% 8% vs 84% 8% vs 84% P P
Thomas et al RA 6/10 5/10 C=15 T=16 SI SI SI P P
Lutz et al P 4/8 69 75% 75% 75% P P
Butterman P 4/8 232 SI SI SI P P
Butterman P 4/8 169 NA NA 42% – 56% P P
Botwin P 4/8 34 75% 75% 75% P P

P=prospective; PC=placebo controlled; RA=randomized; DB=double blind; LA=Local Anaesthetic; S=Steroids; SI=significant improvement=control; T=treatment; NA=not available;  P=positive; N=negative; vs=versus

Summary:

The evidence for:

a)      Lumbar nerve root repair is:

  • Strong for short term
  • Moderate for long term

b)      FBSS and spinal stenosis is limited

c)      Disc extrusion is undermined

4.3.7.      Adhesiolysis:

The purpose of Adhesiolysis treatment is to eliminate the effects of scar formation, which can physically prevent the direct application of drugs to nerves or other tissues.

4.3.7.1  Epidural Adhesiolysis:

The evidence from trials of Epidural Adhesiolysis is as follows:

Study Study Characteristics Methodological Quality Score No Pts Initial Relief Long Term Relief
AHRQ Score(s) Cochrane Score(s) < 3 Mnths 3Mnths 6Mnths 12Mnths Short-Term < 3Mnths Long-Term Relief > 3 Mnths
Manohickanti et al RA, DB 10/10 10/10 G1=25 G2=25 G3=25 33% 64% 72% 0% 64% 72% 0% 60% 72% 0%  60% 72% P P
Heavnet et al RA, DB 7/10 7/10 59 83% 49% 43% 49% P P
Manchikanti RA 5/10 6/10 C=15 TX=30 NSI 97% NSI 97% NSI 93% NSI 47% P P
Manchikanti et al R 4/8 129 79% 68% 36% 13% P N
Manchikanti et al R 4/8 60 100% 90% 72% 52% P P

RA=randomised; DB=double blind; R=retrospective; NA=not available; NSI=no significant improvement; P=positive=; N=negative

4.3.7.2. Endoscopy Adhesiolysis

The evidence from trials of Endoscopy Adhesiolysis is as follows:

Study

Study Characteristic

Methodological Quality Score(s)

No Pts

Initial Relief

Long Term Relief

Results

AHRQ Score(s)

Cochrane Score(s)

<3 Mnths

3 Mnths

6 Mnths

12 Mnths

Short Term < 3 Mnths

Long Term Relief > 3 Mnths

Manchikanti et al 93 RA, DB 10/10 10/10 C=33 Tx=50 33% vs 90% 0% vs 80% 0% vs 56% 0% vs 48% P P
Igarashi P 5/8 Mono=34 SI SI SI in mono SI in mono P P
Ceurts et al P 6/8 20 55% 55% 40% 35% P P
Richardson et al P 4/8 34 SI SI SI SI P N
Manchikanti et al R 4/8 60 100% 75% 40% 22% P P
Menchikanti et al R 4/8 85 100% 77% 52% 21% P P

P=prospective; R=retrospective; PC=placebo controlled; RA=randomized; DB=double blind; NA=not available; N=negative; P=positive; SI=significant improvement; Mono: monosegmental; Multi: multisegmental

Summary:

a)      The evidence for the effectiveness of an epidural is strong for chronic low back pain and lower extremity pain.

b)      The evidence for success of an endoscopy is:

  • Strong for short term
  • Moderate for long term relief in chronic refractory low back pain and lower extremity pain.
  1. Spinal Cord Stimulator (SCS):

The mechanism of the SCS is based on the Gate-Control Theory. Stimulation of large, low threshold fibres would close the gate to reception of small fibre information. (C & A delta fibres).

Evidence: “Failed Back Surgery Syndrome” (FBSS)

i)                    In a systemic review of FBSS patients, the aim was to determine whether SCS or Re-Operation was more effective for the relief of pain.

ii)                  A second was to investigate SCS as a “Late” or “Last Treatment” strategy.