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
  Purpose

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.


Condition Intervention
Myofacial Pain Syndromes
Other: low-level laser therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Is Low-level Laser on Traditional Acupoint as Effective as That on Trigger Point in the Management of Cervical Myofascial Pain Syndrome?

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 1.pain scores [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    1. pain score: visual analog scale (VAS)


Secondary Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: February 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: laser to acupoint 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
Sham Comparator: sham laser to acupoint 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 trigger point 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
Sham Comparator: sham laser to trigger point 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01516502

Locations
Taiwan
Chang Gung Memorial Hospital
TaoYuan county, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Chair: Alice.M.K Wong, Professor Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan
  More Information

No publications provided

Responsible Party: Alice May-Kuen Wong, professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01516502     History of Changes
Other Study ID Numbers: 98-0569B
Study First Received: October 19, 2011
Last Updated: January 24, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
laser therapy
myofascial pain syndrome
acupoint
trigger point
range of motion

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Myofascial Pain Syndromes
Fibromyalgia
Facial Neuralgia
Disease
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on October 01, 2014