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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alice May-Kuen Wong, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01516502
First received: October 19, 2011
Last updated: January 24, 2012
Last verified: January 2012

October 19, 2011
January 24, 2012
February 2011
August 2011   (final data collection date for primary outcome measure)
1.pain scores [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
1. pain score: visual analog scale (VAS)
Same as current
Complete list of historical versions of study NCT01516502 on ClinicalTrials.gov Archive Site
  • 2. pressure pain threshold at the trigger point [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    2. pressure pain threshold at the trigger point
  • 3. cervical range of motion [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    3. cervical range of motion: flexion, extension, bending and rotation
Same as current
Not Provided
Not Provided
 
The Efficacy of Low-level Laser on Cervical Myofascial Pain Syndrome
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Myofacial Pain Syndromes
Other: low-level laser therapy
An infrared (the low-level laser, class IIIb) gallium aluminum arsenide (Ga-Al-As) diode laser device (MediUm-TECH Medizingeräte GmbH, Germany) with a wavelength of 810nm and a maximum power output of 150mW in the continuous wave mode
Other Name: low-power laser therapy
  • Active Comparator: laser to acupoint
    Intervention: Other: low-level laser therapy
  • Sham Comparator: sham laser to acupoint
    Intervention: Other: low-level laser therapy
  • Active Comparator: laser to trigger point
    Intervention: Other: low-level laser therapy
  • Sham Comparator: sham laser to trigger point
    Intervention: Other: low-level laser therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01516502
98-0569B
No
Alice May-Kuen Wong, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Study Chair: Alice.M.K Wong, Professor Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan
Chang Gung Memorial Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP