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

Primary Purpose

Myofacial Pain Syndromes

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
low-level laser therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofacial Pain Syndromes focused on measuring laser therapy, myofascial pain syndrome, acupoint, trigger point, range of motion

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

laser to acupoint

sham laser to acupoint

laser to trigger point

sham laser to trigger point

Arm Description

Outcomes

Primary Outcome Measures

1.pain scores
1. pain score: visual analog scale (VAS)

Secondary Outcome Measures

2. pressure pain threshold at the trigger point
2. pressure pain threshold at the trigger point
3. cervical range of motion
3. cervical range of motion: flexion, extension, bending and rotation

Full Information

First Posted
October 19, 2011
Last Updated
January 24, 2012
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01516502
Brief Title
The Efficacy of Low-level Laser on Cervical Myofascial Pain Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofacial Pain Syndromes
Keywords
laser therapy, myofascial pain syndrome, acupoint, trigger point, range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laser to acupoint
Arm Type
Active Comparator
Arm Title
sham laser to acupoint
Arm Type
Sham Comparator
Arm Title
laser to trigger point
Arm Type
Active Comparator
Arm Title
sham laser to trigger point
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
low-level laser therapy
Other Intervention Name(s)
low-power laser therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
1.pain scores
Description
1. pain score: visual analog scale (VAS)
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
2. pressure pain threshold at the trigger point
Description
2. pressure pain threshold at the trigger point
Time Frame
10 minutes
Title
3. cervical range of motion
Description
3. cervical range of motion: flexion, extension, bending and rotation
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice.M.K Wong, Professor
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
TaoYuan county
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35166212
Citation
Chang WH, Tu LW, Pei YC, Chen CK, Wang SH, Wong AM. Comparison of the effects between lasers applied to myofascial trigger points and to classical acupoints for patients with cervical myofascial pain syndrome. Biomed J. 2021 Dec;44(6):739-747. doi: 10.1016/j.bj.2020.05.020. Epub 2020 Jun 13.
Results Reference
derived

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

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