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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01516502

Collaborator

(none)

100

Enrollment

Location

Arms

5.9

Duration (Months)

16.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myofacial Pain Syndromes	Other: low-level laser therapy	N/A

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 Design

Study Type:

Interventional

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 :

Feb 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: low-power laser therapy

Outcome Measures

Primary Outcome Measures

1.pain scores [10 minutes]
1. pain score: visual analog scale (VAS)

Secondary Outcome Measures

2. pressure pain threshold at the trigger point [10 minutes]
2. pressure pain threshold at the trigger point
3. cervical range of motion [10 minutes]
3. cervical range of motion: flexion, extension, bending and rotation

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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