NCT01516502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
Last Updated

January 25, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

October 19, 2011

Last Update Submit

January 24, 2012

Conditions

Myofacial Pain Syndromes

Keywords

laser therapymyofascial pain syndromeacupointtrigger pointrange of motion

Outcome Measures

Primary Outcomes (1)

  • 1.pain scores

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

    10 minutes

Secondary Outcomes (2)

  • 2. pressure pain threshold at the trigger point

    10 minutes

  • 3. cervical range of motion

    10 minutes

Study Arms (4)

laser to acupoint

ACTIVE COMPARATOR
Other: low-level laser therapy

sham laser to acupoint

SHAM COMPARATOR
Other: low-level laser therapy

laser to trigger point

ACTIVE COMPARATOR
Other: low-level laser therapy

sham laser to trigger point

SHAM COMPARATOR
Other: low-level laser therapy

Interventions

low-level laser therapyOTHER

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

Also known as: low-power laser therapy
laser to acupointlaser to trigger pointsham laser to acupointsham laser to trigger point

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • cervical spine lesion, such as radiculopathy or myelopathy,
  • fracture or surgery of cervical spine,
  • cervical spine instability, and
  • cognitive deficits or psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35166212DERIVED

MeSH Terms

Conditions

Facial NeuralgiaMyofascial Pain Syndromes

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Facial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Alice.M.K Wong, Professor

    Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 19, 2011

First Posted

January 25, 2012

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 25, 2012

Record last verified: 2012-01

Locations

TW(1)