NCT03333213

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable low-back-pain

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

November 2, 2017

Last Update Submit

November 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Pain on movement

    12 weeks

  • Functional disability

    12 weeks

  • Pressure-pain threshold (PPT)

    12 weeks

  • Mechanical detection threshold (MDT)

    12 weeks

  • Vibration detection threshold (VDT)

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Gua Sha therapy

EXPERIMENTAL

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

Waitlist control group

NO INTERVENTION

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.

Interventions

Gua ShaOTHER
Gua Sha therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 6, 2017

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share