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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03333213
Other study ID # 08-3594
Secondary ID
Status Completed
Phase N/A
First received November 2, 2017
Last updated November 2, 2017
Start date January 1, 2009
Est. completion date December 1, 2010

Study information

Verified date November 2017
Source Universität Duisburg-Essen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 1, 2010
Est. primary completion date December 1, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Gua Sha


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universität Duisburg-Essen

Outcome

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