The Efficacy of Low-level Laser on Cervical Myofascial Pain Syndrome

Brief Summary

Official Title: “Is Low-level Laser on Traditional Acupoint as Effective as That on Trigger Point in the Management of Cervical Myofascial Pain Syndrome?”

Objective: To compare the effectiveness of application of low-level laser therapy (LLLT) to trigger points and traditional acupoints for patients with cervical myofascial pain syndrome (MPS).

Design: A single-blinded, randomized, placebo-controlled trial Setting: University rehabilitation hospital Participants: One hundred and twenty one patients with cervical MPS Intervention: The investigators performed this experiment using low level 810-nm gallium aluminum arsenide (Ga-Al-As) laser. One hundred participants were randomly assigned to four treatment groups, including (1) acupoint therapy (2) acupoint control (3) trigger point therapy and (4) trigger point control groups.

Main Outcome measures: The investigators evaluated the patient's visual analogue scale (VAS) pain scores, pressure pain threshold and cervical range of motion (ROM) before and after the therapy.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
  • Study Primary Completion Date: August 2011

Detailed Clinical Trial Description

Low level laser therapy (LLLT) has been promoted since 1960s. It was clinically applied on neurological, musculoskeletal and soft tissue disorders, with the effects such as acceleration of wound healing, edema reduction in human flexor tendon injuries, improvement of morning stiffness, and pain relief in rheumatoid arthritis and lateral epicondylitis. As for relief of musculoskeletal pain, however, the effect of LLLT is controversial. Some studies reported that LLLT was a safe and effective treatment for relief of musculoskeletal pain, while others considered LLLT as ineffective in treating certain musculoskeletal diseases.

LLLT has been used to stimulate traditional acupoints, which is denoted as laser acupuncture. In addition to pain relief, laser acupuncture has been reported to be effective in a variety of disorders such as intractable hiccups,enuresis, as well as weight reduction. Nevertheless, the underlying mechanisms and modes of application of laser acupuncture remain unclear.

There has been evidence that needle acupuncture on traditional acupoints or trigger points may ease neck pain. However, needle acupuncture has some limitations because it is an invasive procedure with risk of infection or pneumothorax. Besides, some patients were not able to tolerate the discomfort from needle manipulation during acupuncture therapy.

LLLT is a type of non-invasive painless therapy and hence a good alternative to needle acupuncture. LLLT has been used to treat neck pain since 1981 and demonstrated significant reduction of pain intensity and improvement of cervical range of motion (ROM) in patients with cervical myofascial pain syndrome (MPS). In most of the studies on LLLT and cervical MPS, trigger points were chosen as the application area domain for LLLT. However, there is no report yet to compare the effectiveness of LLLT on trigger points and traditional acupoints.

In the present single-blinded, randomized, controlled study, the investigators aimed to investigate the effectiveness of application of LLLT to the trigger points and traditional acupoints in patients with cervical MPS. The outcome measurement was pain relief and the improvement of cervical ROM, on which the findings could provide in-depth understanding of the therapeutic mechanism of LLLT and further allow more flexible options of clinical application.

Interventions Used in this Clinical Trial

  • Other: low-level laser therapy
    • An infrared (the low-level laser, class IIIb) gallium aluminum arsenide (Ga-Al-As) diode laser device (MediUm-TECH Medizinger√§te GmbH, Germany) with a wavelength of 810nm and a maximum power output of 150mW in the continuous wave mode

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: laser to acupoint
  • Sham Comparator: sham laser to acupoint
  • Active Comparator: laser to trigger point
  • Sham Comparator: sham laser to trigger point

Outcome Measures for this Clinical Trial

Primary Measures

  • 1.pain scores
    • Time Frame: 10 minutes
      Safety Issue?: No

Secondary Measures

  • 2. pressure pain threshold at the trigger point
    • Time Frame: 10 minutes
      Safety Issue?: No
  • 3. cervical range of motion
    • Time Frame: 10 minutes
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

1. complaint of regional pain in the neck,

2. presence of a palpable taut band,

3. presence of a tender spot along the length of taut ban, and

4. reproduction or enhancement of the clinical symptoms by compression of the active trigger point

Exclusion Criteria

1. cervical spine lesion, such as radiculopathy or myelopathy,

2. fracture or surgery of cervical spine,

3. cervical spine instability, and

4. cognitive deficits or psychiatric illness

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alice May-Kuen Wong, professor – Chang Gung Memorial Hospital
  • Overall Official(s)
    • Alice.M.K Wong, Professor, Study Chair, Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01516502