Terra Quant Laser Device for Shoulder Pain Double Blind Trial

Terra Quant Laser Device for Shoulder Pain Double Blind Trial

by Dr Gabriel (Gabi) Zeilig & Prof Remi Guibert listed in energy medicine, originally published in issue 113 - July 2005

Background

Shoulder pain is a common complication in hemiplegic and spinal cord injured patients. It usually starts during the acute rehabilitation phase leading to further activity limitations. The contributing factors to shoulder pain in both hemiplegic and spinal cord injured patients are related to the neurological and musculoskeletal lesions: muscle weakness, loss of sensitivity, spasticity, impingement and rotator cuff tear. Upper extremity overuse has been proposed as an aggravating factor in the aetiology of shoulder pain in this population. Obesity, age and mental stress are further risk factors.[1]

Medications, subacromial or intra-articular injections, ultrasound, local heating and ice application, functional electrical stimulation, exercises or rest, and surgical tendon repair are some of the various interventions proposed for treating the shoulder pain.[2],[3] Clinical, not randomized, placebo trials report acupuncture, electromagnetic field, and laser possible pain effectiveness.[4]

TerraQuant (aka Handy Cure) is a unique device which combines low level pulse laser therapy (LLLT), pulsating infrared radiation, visible red light and static magnetic fields, providing their synergic therapeutic effects (Table 1 – not shown here).

A randomized double-blind controlled trial was designed to test whether TerraQuant is more effective than a sham device among hemiplegic and spinal cord injured patients with shoulder pain and reduced range of motion resulting from inflammation (OA, Tendonitis, Bursitis).

Methods

Research design

The study is a randomized double-blind controlled trial with pre- and post-measures. Two identical unmarked TerraQuant devices were used, one being deactivated. Both the Active and the Sham TerraQuant emitted a flashing red light during treatment sessions. Given that LLLT, infrared and static fields are non visible, it was impossible to detect which TQ was Active and which was Sham. A convenience sample of 18 subjects fulfilling eligibility criteria participated in the study. Eligible subjects were randomly allocated to either the experimental group (Active TQ) or to the control group (Sham TQ).

Interventions

The TerraQuant treatment consisted of eight sessions, (five minutes per zone), performed every second day. The device was applied on the most painful areas as detected by the therapist. One TerraQuant was active with LLLT at 50 Hz frequency (Active TQ), one TerraQuant was deactivated (Sham TQ). Both groups also received similar standard conventional therapy: a 30-minutes physical therapy treatment according to the diagnosis included one or several of the following: manual therapy, soft tissue manipulation, active range of motion and strengthening.

Subjects

Twenty eligible subjects with moderate to severe shoulder pain were recruited within a period of one month from inpatients and outpatients of one of the departments of neurological rehabilitation affiliated to Tel Aviv University. Eligibility criteria consisted of:

• Shoulder pain of a musculoskeletal benign nature, such as inflammation, arthritis, muscle trigger point overuse, impingement and degenerative changes;
• Referral from a physician after a full physical evaluation including radiography;
• Onset of shoulder pain between two weeks and three months prior to inclusion in the study;
• No other additional medical conditions which could account for shoulder pain;
• No perceptual or cognitive impairment and medically stable;
• Signed informed consent. The study protocol was approved by the Ethics and Investigation Committee of the Chaim Sheba Medical Centre.

Procedure

The subjects were assessed by a Physician (MD) and a Physical Therapist (PT) prior to the beginning of experimentation. The assessments included the medical history, examination of shoulder soft tissues, evaluation of range of motion (ROM) of the gleno-humeral joint (GHJ) using a goniometer attached to the chest and the involved arm, and evaluation of pain using a Visual Analog Scale (VAS) anchored at 'no pain' and 'worst pain ever experienced'. The total possible score on the scale ranged from zero to ten.

The same PT and MD assessed all subjects again after completion of the series of eight TQ treatment sessions.

Results

Eighteen patients completed the study (mean age 46 + 15.5, 15 men and three women). Two patients stopped participation because of lack of time. Twelve subjects suffered from spinal cord injury (SCI), four from paraplegia and eight from tetraplegia. Six subjects had hemiplegia post cerebrovascular accident (CVA). Ten subjects received the Active TQ, and eight received the Sham TQ.

Range of Movement:

Subjects in the Active TQ group experienced a statistically significant greater improvement in shoulder ROM (p=0.001) than those in the Sham TQ.

Pain

Twelve subjects (six Active TQ, six Sham TQ) had pre- and post-VAS evaluations. They experienced a tendency for greater pain reduction (VAS) however, not achieving statistical significance (p-0.1). The remaining six patients did not complete the VAS evaluation because of technical reasons.

Discussion and Conclusions

Painful shoulder is a major and frequent complication for individuals with hemiplegia and spinal cord injury. Shoulder pain may lead to movement restriction, loss of flexibility and function and causes important quality of life restrictions.

Many interventions to treat this condition have been reported; yet their effectiveness is questionable.

We report the results of a randomized double-blind controlled clinical trial to test the efficacy of a device which combines LLLT, pulsating infrared radiation, visible red light and static magnetic fields.

The primary effect of LLLT is a local time response to direct irradiation and includes vasodilatation with increased circulatory flow; increased macrophages and fibroblast activity and improved metabolic function of depressed or damaged cells. Delayed response consists of a systemic effect caused by circulating photoproducts of irradiation in the blood and lymphatic systems. Increased plasma concentrations of certain types of prostaglandins and endorphins have all be identified and play a major role in the mechanism of pain attenuation. LLLT has been shown to be safe and effective.[5],[6],[7],[8] The mechanism of action of static magnetic therapy is not completely understood. Possible explanations of its beneficial effect on the body include that static magnetic fields can decrease the firing rate of the c-type chronic pain neurons; change the rate of enzyme mediated reactions which may play a role in inflammatory cascades and free radical generation; modulate intracellular signalling by affecting the functioning of calcium channels in cell membranes; and cause small changes in blood flow.[9]

Our study has several limitations, the main one being the relatively small number of participants, especially for the pain reduction evaluation.

In conclusion, the TerraQuant treatment proved to have greater efficacy than sham treatment in patients with decreased shoulder ROM over and beyond conventional treatment. No side effects were observed. There was also a positive evolution trend in allaying the shoulder pain; yet because of the small sample it did not reach statistical significance.

The results of this study confirm the existing scientific literature on the efficacy of LLLT and static magnet therapy and suggest that TerraQuant may be an effective and economical tool in the treatment of pain and reduced range of motion in people with shoulder problems following CVA or SCI. These results are of potentially great significance to the patients, because of the burden and limitations of function due to shoulder pain aggravating their usually limited functionality in daily life. Larger and more randomized trials are needed in order to confirm this preliminary data.

References

1. Miranda H et al. A prospective study on work related factors and physical exercise as predictors of shoulder pain.Occup Environ Med58(8): 528-534. 2001.
2. Buchbinder et al. Corticosteroid injections for shoulder pain. Cochrane Review. Cochrane Database Syst Rev(1):CD00414. 2003.
3. Green et al. Corticosteroid injections for shoulder pain. Cochrane Review. Cochrane Database Syst Rev. (2):CD001156. 2000.
4. Nabeta et al. Relief of chronic neck and shoulder pain by manual acupuncture to tender points – a sham-controlled randomized trial. Complement Ther Med. 10(4): 217-222. 2003.
5. Simunovic Z. Low level laser therapy with trigger points technique: a clinical study on 243 patients. J Clin Laser Med Surg14(4): 163-167. 1996.
6. Ozdemir F et al. The clinical efficacy of low power laser therapy on pain and function in cervical osteoarthritis. Clin Rheumatol. 20(3): 181-184. 2001.
7. Lewith GT et al. A randomized trial to evaluate the effect of infrared stimulation of local trigger points versus placebo, on pain caused by cervical osteoarthritis. Acupunct Electrother Res. 6(4): 277-284. 1981.
8. England et al. Low power laser therapy of shoulder tendonitis. Scan J Rheumatol18(6): 427-31. 1989.
9. Weintraub MI et al. Static magnetic field therapy for symptomatic diabetic neuropathy: a randomized, double-blind, placebo-controlled trial. Arch Phys Med Rehabil. 84: 736-746. 2003.

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