The Efficacy of Low-level Laser on Cervical Myofascial Pain Syndrome
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ClinicalTrials.gov Identifier: NCT01516502 |
Recruitment Status
:
Completed
First Posted
: January 25, 2012
Last Update Posted
: January 25, 2012
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Myofacial Pain Syndromes | Other: low-level laser therapy | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
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? |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
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
|
- 1.pain scores [ Time Frame: 10 minutes ]1. pain score: visual analog scale (VAS)
- 2. pressure pain threshold at the trigger point [ Time Frame: 10 minutes ]2. pressure pain threshold at the trigger point
- 3. cervical range of motion [ Time Frame: 10 minutes ]3. cervical range of motion: flexion, extension, bending and rotation

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Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- complaint of regional pain in the neck,
- presence of a palpable taut band,
- presence of a tender spot along the length of taut ban, and
- reproduction or enhancement of the clinical symptoms by compression of the active trigger point
Exclusion Criteria:
- cervical spine lesion, such as radiculopathy or myelopathy,
- fracture or surgery of cervical spine,
- cervical spine instability, and
- cognitive deficits or psychiatric illness

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516502
Taiwan | |
Chang Gung Memorial Hospital | |
TaoYuan county, Taiwan, 333 |
Study Chair: | Alice.M.K Wong, Professor | Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan |
Responsible Party: | Alice May-Kuen Wong, professor, Chang Gung Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT01516502 History of Changes |
Other Study ID Numbers: |
98-0569B |
First Posted: | January 25, 2012 Key Record Dates |
Last Update Posted: | January 25, 2012 |
Last Verified: | January 2012 |
Keywords provided by Alice May-Kuen Wong, 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 Pain Facial Neuralgia Disease Pathologic Processes Mental Disorders Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases |