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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
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 2, 2017
    Last Updated
    November 2, 2017
    Sponsor
    Universität Duisburg-Essen
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    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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