- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516502
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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TaoYuan county, Taiwan, 333
- Chang Gung memorial hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: laser to acupoint
|
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 Names:
|
Sham Comparator: sham laser to acupoint
|
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 Names:
|
Active Comparator: laser to trigger point
|
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 Names:
|
Sham Comparator: sham laser to trigger point
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1.pain scores
Time Frame: 10 minutes
|
1. pain score: visual analog scale (VAS)
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10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2. pressure pain threshold at the trigger point
Time Frame: 10 minutes
|
2. pressure pain threshold at the trigger point
|
10 minutes
|
3. cervical range of motion
Time Frame: 10 minutes
|
3. cervical range of motion: flexion, extension, bending and rotation
|
10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Alice.M.K Wong, Professor, Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Disease
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Cranial Nerve Diseases
- Facial Nerve Diseases
- Syndrome
- Fibromyalgia
- Somatoform Disorders
- Myofascial Pain Syndromes
- Facial Neuralgia
- Facial Pain
Other Study ID Numbers
- 98-0569B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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