Self Health Treatment and Monitoring

Gabi Zeilig, MD, Dept of Neurological Rehabilitation The Chaim Sheba Medical Center, Tel Hashomer, Israel.

Purpose of the study: to test the efficacy of the TerraQuant medical device on shoulder
pain resulting from inflammation (OA, Tendonitis, Bursitis).

Background: TerraQuant 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 effect. 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 (1,2,3,4)


Methods:
Research design: The study is a randomised double-blind controlled trial with pre and post measures. Two identical unmarked TerraQuant devices were used one being deactivated. A sample of convenience according to predetermined eligibility criteria were used. Eligible subjects were randomly allocated to either the experimental group or to the control group.Intreventions: The TerraQuant treatment consisted of eight (8) sessions (5 minutes per zone),were performed every second day. One TerraQuant was active with LLLT at 50 Hzfrequency (Active TQ), one TerraQuant was deactivated (Sham TQ). Both groups received as well 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, AROM 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 2 weeks and 3 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.

Procedure: The subjects were assessed by a Physician (MD) and by a Physical Therapist (PT) prior to the beginning of experimentation. The assessments included
- Evaluation of Active Range of Motion of the gleno-humeral joint (GHJ) using a goniometer.
- Evaluation of muscle strength according to MMT.
- Evaluation of pain using a Visual Analog Scale (VAS).

After completion of the series of 8 sessions the same PT and MD assessed all subjects again to maintain inter-rater reliability. A follow up assessment was performed 1month after termination of treatment.


Results: Eighteen (18) patients completed the study (mean age 46 + 15.5, 15 men and 3 women).. Twelve (12) subjects had spinal cord injury (SCI), four with paraplegia and eight with tetraplegia. Six (6) subjects had hemiplegia post cerebrovascular accident (CVA). XX subjects received the Active TQ, and YY received the Sham TQ. Twelve (12) subjects (aa aActive TQ, BB Sham TQ) had pre and post VAS evaluations. Subjects receiving the Active TQ experienced a statistically significant greater improvement in shoulder ROM (p=0.001) than those receiving the Sham TQ. They also experienced a tendency for greater pain reduction (VAS) however not achieving statistical significance (p-0.1).
Conclusions: TerraQuant treatment proved to have greater efficacy than sham treatment in patients with decreased shoulder ROM over and beyond conventional treatment. No sideeffects
were observed. The results of this study confirm the existing scientific literature on the efficacy of LLLT and suggests that that TerraQuant therapy 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. Larger and randomized trials are needed in order to confirm this preliminary data.

Gabi


1. Simunovic Z. Low level laser therapy with trigger points technique: a clinical study on 243 patients. J Clin Laser Med Surg. 14(4): 163-167. 1996.
2. 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.
3. Lewith GT, Machin D. A randomised trial to evaluate the effect of infra-red stimulation of local trigger points versus placebo, on pain cused by cervical osteoarthritis. Acupunct Electrother Res. 6(4): 277-284, 1981.
4. England et al. Low power laser therapy of shoulder tendinitis. Scan J Rheumatol.18(6):427-31, 1989