Back Therapy Research and Regulatory Information

TheraCurve Lumbar Orthosis and Heat Therapy System Outline

1. Back Support and extension therapy research
2. Heat Therapy Research
3. Guideline – (www.guideline.gov)
• A. Evidence-informed primary care management of low back pain
• B. American College of Occupational and Environmental Medicine (ACOEM)

1. Back support and extension therapy research

Although the TheraCurve is designed as a Lumbar orthosis device intended for back support there is research showing extension therapy is beneficial for relief of back pain. Listed below are a few of the many research articles concluding the benefits of extension therapy.

About 300 patients evaluated for eligibility of who 63 met inclusion criteria: back pain with referral below the buttock, plus centralization with 10 repeated extension exercises in standing or lying. These 63 patients were randomised to an extension protocol (extension exercises and posterior-to-anterior mobilisation) or strengthening programme for flexors and extensors. There were significant differences at 1 and 4 weeks and at 6 months for Oswestry scores favouring the extension protocol group, but only in pain scores at 1 week. There were significant differences in centralization of symptoms favouring the extension protocol group.

Delitto suggests that treatment strategy based on signs and symptoms and response to movement may result in a more effective outcome compared with an unmatched non-specific treatment. Patients classified as extension-responders did better with an extension, than a flexion oriented programme.

Gagne AR, Hasson SM; Lumbar extension exercises in conjunction with mechanical traction for the management of a patient with a lumbar herniated disc. Physio Theory & Pract; 256-266, 2010.

Case study of patient showing some improvement with extension exercises and greater improvement when combined with traction over 14 sessions of treatment.

Hefford C; McKenzie classification of mechanical spinal pain: profile of syndromes and directions of preference. Manual Therapy; 13.75-81, 2008.

Survey of over 300 consecutive patients with cervical, thoracic and lumbar pain from over 30 therapists, which describes mechanical classification, pain patterns and directional preference of reducible derangements. Over 90% were classified with a mechanical syndrome and more than 80% with derangement. Extension was the commonest directional preference by far, especially amongst patients with central or symmetrical symptoms, but also in over 50% of patients symptoms in the arm or leg.

Larsen K, Weidick F, Leboeuf-Yde C.; Can passive prone extensions of the back prevent back problems?: a randomized, controlled intervention trial of 314 military conscripts. Spine; Dec 15;27(24):2747-52, 2002.

314 male conscripts randomised into 2 groups: one group received theory session based on TYOB, disc model, tape to back, and instructed to do 15 EIL X 2 a day for period of military duty. 214 (68%) completed follow-up at 12 months. 1-year prevalence LBP in experimental group 33%, compared to 51% in control. Numbers seeking medical help for LBP also significantly less (9% to 25%). In those who had reported LBP at baseline 1-year prevalence 45% to 80%.

Manca A, Dumville JC, Torgerson DJ, Klaber Moffett JA, Mooney MP, Jackson DA, Eaton S ; Randomized trial of two physiotherapy interventions for primary care back and neck pain patients: cost-effectiveness analysis. Rheumatology; 46:1495-15010, 2007.

This was an economic analysis of the Klaber-Moffett et al (2007) trial. Despite a mean of one additional visit in the McKenzie group and being more expensive the McKenzie group had additional benefit and was deemed to be cost-effective in regard to acquiring additional Quality Adjusted Life Years

Education in the control of early morning flexion produced significant reductions in pain intensity, days in pain, disability and medication use. High drop-out rates show the difficulty of getting people to make such behavioural changes.

Spratt KF, Weinstein JN, Lehmann TR, Woody J, Sayre H; Efficacy of flexion and extension treatments incorporating braces for low-back pain patients with retrodisplacement, spondylolisthesis, or normal sagittal translation Spine; 18(13):1839-1849, 1993.

Improvement in the extension group was significantly greater, regardless of type of radiographic abnormality, than flexion or control group.

Udermann BE, Mayer JM, Donelson RG, Graves JE, Murray SR; Combining lumbar extension training with McKenzie therapy: effects on pain, disability, and psychosocial functioning in chronic low back pain patients. Gundersen Lutheran Med J; 3:7-12, 2004.

18 patients received McKenzie therapy or McKenzie plus resistance training. There were no significant difference between groups at 4 weeks, but strength, endurance, range of movement and quality of life measures on the SF36 had significantly improved in both groups.

Bybee RF, Mamantov J, Meekins W, Witt J, Byars A, Greenwood M; Comparison of two stretching protocols on lumbar spine extension J Back Musculoskeletal Rehab; 21.153-159, 2008.

101 volunteers without back pain were randomised to one of 3 groups: repeated extension or static extension stretching or a control group. Participants were to perform stretches 8 times a day for 8 weeks. Both stretching groups increased range of movement at 4 and 8 weeks, the repeated more than the static stretch.

Clare HA, Adams R, Maher CG ; Construct validity of lumbar extension measures in McKenzie’s derangement syndrome. Manual Therapy; 12:328-334, 2007.

50 consecutive patients were classified as derangement (40) or non-derangement (10) and treated with extension procedures; extension range of movement was measured at baseline and at day 5. All patients gained extension but those classified as derangement had significantly more improvement in extension and significantly better globally perceived effect scores. The modified Schober test in standing was the most responsive was to measure extension range of the 4 methods tested.

Alexander LA, Hancock E, Agouris I, Smith FW, MacSween A ; The response of the nucleus pulposus of the lumbar intervertebral discs to functionally loaded positions. Spine; 32:1508-1512, 2007.

First ever study using upright magnetic resonance imaging of effect of functional positions on movement of the nucleus pulposus (NP) in 11 volunteers. In sitting there was significantly less lordosis than prone lying and standing, and significantly more posterior migration of the NP than other positions.

Aota Y, Iizuka H, Ishige Y, Mochida T, Yoshihisa T, Uesugi M, Saito T; Effectiveness of a lumbar support continuous passive motion device in the prevention of low back pain during prolonged sitting. Spine; 32(23):674-677, 2007.

Asymptomatic volunteers tested prolonged sitting with 1) no lumbar support, 2) static lumbar support, or 3) continuous passive motion lumbar support. There were significant differences between 1 and 2 / 3 in discomfort / pain, stiffness and fatigue, but no significant differences between 2 and 3

Bakker EW, Verhagen AP, Lucas C, Koning HJ, de Haan RJ, Koes BW.; Daily spinal mechanical loading as a risk factor for acute non-specific low back pain: a case-control study using the 24-Hour Schedule Eur Spine J.; Jan;16(1):107-13, 2007.

100 cases with acute back pain were compared by a blinded assessor with 100 controls using the 24-Hour Schedule, which quantifies spinal mechanical loading taking into account duration of activity, sagittal movement and loading status. There were no significant differences between cases and controls in predominant work postures. There were significant differences between the groups in hours in flexion and extension, with cases spending significantly more hours in flexion and significantly less likely to be in extended postures.

Beattie PF, Arnot CF, Donley JW, Noda H, Bailey L ; The immediate reduction in low back pain intensity following lumbar joint mobilization and prone press-ups is associated with increased diffusion of water in the L5-S! intervertebral disc. JOSPT; 40.256-264, 2010.

20 patients with back pain who received extension mobilizations and extension in lying were monitored with MRI before and after, and classified as responders if there was a reduction in pain score of 2 or more. Responders demonstrated a mean increase in diffusion coefficient in the middle portion of the disc compared to a mean decrease in the non-responders.

Beattie PF, Brooks WM, Rothstein JM, Sibbitt WL Jr, Robergs RA, MacLean T, Hart BL.; Effect of lordosis on the position of the nucleus pulposus in supine subjects. A study using magnetic resonance imaging (MRI). Spine; Sep 15;19(18):2096-2102, 1994.

In vivo some anterior displacement of the nucleus pulposus with extension movements was observed. Degenerated discs appear to behave differently from non-degenerated discs.

Botwin KP, Skene G, Torres-Ramos FM, Gruber RD, Bouchlas CG, Shah CP; Role of weight-bearing flexion and extension myelography in evaluating the intervertebral disc. Am J Phys Med Rehab; 80.289-295, 2001.

Three patients with negative MRIs then investigated with weight-bearing flexion-extension myelography, which more clearly demonstrated a herniated nucleus pulposus and compression of the nerve root, which was more pronounced on flexion.

Edmondston SJ, Song S, Bricknell RV, Davies PA, Fersum K, Humphries P, Wickenden D, Singer KP.; MRI evaluation of lumbar spine flexion and extension in asymptomatic individuals. Man Ther; Aug;5(3):158-64, 2000.

Between flexion and extension there was anterior displacement of the nucleus pulposus of 6.7%, this was significant at L1/2, L2/3 and L5/S1. Displacement did not occur in 30% of discs.

Fennell A.J.; Jones, A.P.; Hukins, D.W.L.; Migration of the Nucleus Pulposus Within the Intervertebral Disc DuringFlexion and Extension of the Spine Spine; 21:2753-2757, 1996.

In vivo flexion tends to cause posterior displacement of the nucleus pulposus and extension anterior displacement using MRI.

Geldhof E, De Clercq D, De Bourdeaudhuij I, Cardon G; Classroom postures of 8-12 year old children Ergonomics; 50(10):1571-1581, 2007.

Pupils (N = 105) were observed to spend 85% of classroom time sitting, 28% of which was flexed forward and 91% of time was static. Children who spent more time sitting flexed forward reported significantly more low back pain.

Harrison DD, Harrison SO, Croft AC, Harrison DE, Troyanovich SJ; Sitting biomechanics, part 1: Review of the literature / Sitting biomechanics, part 2: Optimal car driver’s seat and optimal driver’s spinal model. J Manipulative Physiol Ther ; 22:594-609; 23:37-47 2000, 1999.

Extensive literature review on the biomechanical effects and comfort of different sitting postures to identify optimal seating and driving posture. Concludes that maintenance of lumbar lordosis, seat-back inclination, freedom to move, and minimal anterior head translation have been shown to reduce sitting stress and be associated with higher comfort ratings.

O'Sullivan PB, Mitchell T, Bulich P, Waller R, Holte J ; The relationship between posture and back muscle endurance in industrial workers with flexion-related low back pain. Man Ther; 11:264-271, 2006.

24 workers with back pain provoked by flexion activities compared with 21 healthy workers had: significantly reduced muscle endurance, increased posterior pelvic tilt and sat closer to their end range of lumbar flexion.

Powers CM, Beneck GJ, Kulig K, Landel RF, Fredericson M ; Effects of a single session of posterior-to-anterior spinal mobilization and press-up exercise on pain response and lumbar spine extension in people with non-specific low back pain. Phys Ther; 88:485-493, 2008.

Comparison of the effects, on short-term pain scores on extension in standing and extension range as measured by MRI, in 30 patients with back pain randomised to a single session of spinal mobilisation or extension in lying. There were significant improvements in both pain and range in both groups, but no significant differences between the groups.

Pynt J, Higgs J, Mackey M; Seeking the optimal posture of the seated lumbar spine. Physio Theory & Pract ; 17;5-21, 2001.

A review of the literature on the optimal sitting posture for spinal health, based mostly on cadaveric studies, but some clinical studies. They conclude that the arguments in favour of a kyphotic sitting position are not substantiated by research; and that a lordotic position, interspersed with regular movement, is the optimal sitting posture and assists in preventing back pain.

Tsantizos A, Ito K, Aebi M, Steffen T; Internal strains in healthy and degenerated lumbar intervertebral discs. Spine; 30.2129-2137, 2009.

Cadaver study looking at the effects of degeneration and loading on nucleus pulposus deformation. The nucleus migrated to the opposite side of bending direction regardless of loading and significantly more in degenerated discs.

Womersley L, May S.; Sitting posture of subjects with postural backache J Manipulative Physiol Ther; Mar-Apr;29(3):213-8., 2006.

Nine students were classified as postural backache (history of mild backache but no functional disability) and 9 as control (no history of backache). Postural activity was recorded over 3 days and relaxed sustained sitting posture observed with computerized video analysis. The postural backache group had significantly longer periods of uninterrupted sitting and sat with greater flexion when relaxed.

2.) Heat Therapy Research

Cochrane Research: Heat therapy is useful for back spasms or other conditions. A meta-analysis of studies by the Cochrane Collaboration concluded that heat therapy can reduce symptoms of acute and sub-acute low-back pain. Some patients find that moist heat works best (e.g. a hot bath or whirlpool) or continuous low-level heat (e.g. a heat wrap that stays warm for 4 to 6 hours). Cold compression therapy (e.g. ice or cold pack application) may be effective at relieving back pain in some cases.

French S, Cameron M, Walker B, Reggars J, Esterman A (2006). "A Cochrane review of superficial heat or cold for low back pain". Spine 31 (9): 998–1006.

Study Design. Cochrane systematic review.

Objective. To assess the effects of superficial heat and cold therapy for low back pain in adults.

Summary of Background Data. Heat and cold are commonly used in the treatment of low back pain.

Results. Nine trials involving 1,117 participants were included. In two trials of 258 participants with a mix of acute and subacute low back pain, heat wrap therapy significantly reduced pain after 5 days (weighted mean difference [WMD], 1.06; 95% confidence interval [CI], 0.68–1.45, scale range, 0–5) compared with oral placebo. One trial of 90 participants with acute low back pain found that a heated blanket significantly decreased pain immediately after application (WMD, −32.20; 95% CI, −38.69 to −25.71; scale range, 0–100). One trial of 100 participants with a mix of acute and subacute low back pain examined the additional effects of adding exercise to heat wrap and found that it reduced pain after 7 days.

University of London Research:
Dr Brian King, of the UCL Department of Physiology, led the research that found the molecular basis for the long-standing theory that heat, such as that from a hot-water bottle applied to the skin, provides relief from internal pains, such as stomach aches, for up to an hour.

Dr King said: “The pain of colic, cystitis and period pain is caused by a temporary reduction in blood flow to or over-distension of hollow organs such as the bowel or uterus, causing local tissue damage and activating pain receptors.

“The heat doesn’t just provide comfort and have a placebo effect – it actually deactivates the pain at a molecular level in much the same way as pharmaceutical painkillers work. We have discovered how this molecular process works.”

If heat over 40 degrees Celsius is applied to the skin near to where internal pain is felt, it switches on heat receptors located at the site of injury. These heat receptors in turn block the effect of chemical messengers that cause pain to be detected by the body.

The team found that the heat receptor, known as TRPV1, can block P2X3 pain receptors. These pain receptors are activated by ATP, the body’s source of energy, when it is released from damaged and dying cells. By blocking the pain receptors, TRPV1 is able to stop the pain being sensed by the body.

Dr King added: “The problem with heat is that it can only provide temporary relief. The focus of future research will continue to be the discovery and development of pain relief drugs that will block P2X3 pain receptors. Our research adds to a body of work showing that P2X3 receptors are key to the development of drugs that will alleviate debilitating internal pain.”

Scientists made this discovery using recombinant DNA technology to make both heat and pain receptor proteins in the same host cell and watching the molecular interactions between the TRPV1 protein and the P2X3 protein, switched on by capsaicin, the active ingredient in chilli, and ATP, respectively.

3.) Guidelines – (www.guideline.gov)

A.) Evidence-informed primary care management of low back pain (http://www.guidelines.gov/content.aspx?id=15668&search=lumbar+orthosis)

Recommended for Acute/Subacute Back Pain

Cold Packs or Heat

In the first 72 hours recommend cold packs (ice), after that, alternate cold and heat as per patient's preference.

Heat or cold should not be applied directly to the skin, and not for longer than 15 to 20 minutes. Use with care if lack of protective sensation.

B.) American College of Occupational and Environmental Medicine (ACOEM)

(http://www.guidelines.gov/content.aspx?id=12540&search=back+pain+and+acute+back+pain)

Occupational medicine practice guidelines Recommend:

Acute Back Pain: Self-application of heat therapy including a heat wrap
Subacute Back Pain: Self-application of heat therapy including a heat wrap
Chronic Back Pain: Self-application of heat therapy including a heat wrap

Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers. 2nd ed. Elk Grove Village (IL): American College of Occupational and Environmental Medicine (ACOEM); 2007. 366 p. [1310 references]