Gua Sha Therapy for Chronic Low Back Pain

Gua Sha Therapy for Chronic Low Back Pain: a Randomized Controlled Trial

Chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. Gua Sha is a traditional East Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (Oswestry Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Gua Sha

Detailed Description

Chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. Gua Sha is a traditional East Asian therapy traditionally used in the treatment of spinal pain. This study aimed to test the efficacy of Gua Sha therapy in patients with chronic low back pain A total of 50 patients with chronic low back pain were randomized to either two Gua Sha treatments (n=25) or a waitlist control group (n=25). Primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (Oswestry Disability Index), movement-related pain (modified Pain on Movement Questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• non-specific low back pain at least once weekly for at least the previous 3 months
• average back pain intensity hat least 40mm on a 100mm visual analog scale (VAS)

Exclusion Criteria:

• specific low back pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, or oncologic disease
• dystonia
• pregnancy
• invasive treatment of the spine or spinal surgery within the previous 4 weeks
• oral steroids or anticoagulants
• hemophilia or a skin condition in the area to be treated
• started a new treatment for low back pain within the previous month or planning to start a new treatment within the next month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gua Sha therapy; Patients' backs were first covered with Tumarol N Balsam. The study physician then applied a round-edged instrument (the inside smooth edged lip of a metal cap) to patients' skin in downward strokes. Patients were treated twice with a 7-day interval.	Other: Gua Sha
NO_INTERVENTION: Waitlist control group; Treatments in the control group were not regulated but patients were asked to continue their self-directed medical care. They were offered the Gua Sha therapy once the trial was concluded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	100-mm visual analogue scale (VAS) ranging from 0mm meaning 'no pain at all' to 100mm meaning 'the worst pain imaginable'	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		12 weeks
Pain on movement	Pain on Movement Questionnaire (POM)	12 weeks
Functional disability	Oswestry Disability Index (ODI)	12 weeks
Pressure-pain threshold (PPT)	PPT was measured using a digital algometer (Somedic AB, Horby, Sweden).	12 weeks
Mechanical detection threshold (MDT)	MDT was measured with a set of von Frey filaments (Somedic Sales AB, Horby, Sweden).	12 weeks
Vibration detection threshold (VDT)	VDT was determined using a Rydel-Seiffer tuning fork (64 Hz, 8/8 scale)	12 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (ACTUAL): November 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 08-3594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No