Gua Sha Therapy for Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gua Sha
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gua Sha therapy
Waitlist control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pain intensity
100-mm visual analogue scale (VAS) ranging from 0mm meaning 'no pain at all' to 100mm meaning 'the worst pain imaginable'
Secondary Outcome Measures
Pain on movement
Pain on Movement Questionnaire (POM)
Functional disability
Oswestry Disability Index (ODI)
Pressure-pain threshold (PPT)
PPT was measured using a digital algometer (Somedic AB, Horby, Sweden).
Mechanical detection threshold (MDT)
MDT was measured with a set of von Frey filaments (Somedic Sales AB, Horby, Sweden).
Vibration detection threshold (VDT)
VDT was determined using a Rydel-Seiffer tuning fork (64 Hz, 8/8 scale)
Adverse events
Full Information
NCT ID
NCT03333213
First Posted
November 2, 2017
Last Updated
November 2, 2017
Sponsor
Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT03333213
Brief Title
Gua Sha Therapy for Chronic Low Back Pain
Official Title
Gua Sha Therapy for Chronic Low Back Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
December 1, 2010 (Actual)
Study Completion Date
December 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gua Sha therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gua Sha
Primary Outcome Measure Information:
Title
Pain intensity
Description
100-mm visual analogue scale (VAS) ranging from 0mm meaning 'no pain at all' to 100mm meaning 'the worst pain imaginable'
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pain on movement
Description
Pain on Movement Questionnaire (POM)
Time Frame
12 weeks
Title
Functional disability
Description
Oswestry Disability Index (ODI)
Time Frame
12 weeks
Title
Pressure-pain threshold (PPT)
Description
PPT was measured using a digital algometer (Somedic AB, Horby, Sweden).
Time Frame
12 weeks
Title
Mechanical detection threshold (MDT)
Description
MDT was measured with a set of von Frey filaments (Somedic Sales AB, Horby, Sweden).
Time Frame
12 weeks
Title
Vibration detection threshold (VDT)
Description
VDT was determined using a Rydel-Seiffer tuning fork (64 Hz, 8/8 scale)
Time Frame
12 weeks
Title
Adverse events
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gua Sha Therapy for Chronic Low Back Pain
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