The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy
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|ClinicalTrials.gov Identifier: NCT03821194|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : June 11, 2019
A randomized, single-blind, controlled clinical trial is conducted to evaluate the effect of gua sha on the relief of chronic knee joint area pain, and to investigate the association between local skin surface and core temperature changes with chronic pain relief over knee after gua sha. Also, we want to observe the changes before and after gua sha in the local tissues of the knee joint area. We expect to provide more insights into the relevant mechanism of gua sha and relieving pain in chronic knee joint area and establish a complementary therapy for chronic knee joint pain.
Materials and Methods:
In this study, a total of 40 chronic knee joint pain participants will be recruited in the eligible conditions. After agreeing into the clinical study and signing the informed consent form, they will be randomized assigned into the treatment group (20 persons) and control group (20 people). Both groups will be tested for total of 12 days. For treatment group, 2 times of gua sha method will be applied within 12-day test period, the treatments will be on the first day and the fourth day respectively. The control group will be applied 2 times of hot pack method at same period intervals during the 12 days. Both groups will be measured the surface and core temperature of the applied site before and after each method. The visual analog scale (VAS) and the lower extremity functional scale (LEFS) and SF-12 quality of life questionnaire will be performed before and after the test. Ultrasound scans of knee will be performed before and after the test. After the data collection is completed, the analysis is performed in SPSS version 24. Student's t-test and one-way ANOVA methods will be used, with P<0.05 as a significant result.
To establish the positive effect of gua sha therapy to relieve the chronic knee joint pain, and use data and images to infer the mechanism of gua sha therapy on relieving chronic knee joint pain.
|Condition or disease||Intervention/treatment||Phase|
|Pain, Chronic||Other: Gua sha Other: hot pack||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||chronic knee joint pain patients|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy|
|Actual Study Start Date :||January 25, 2019|
|Estimated Primary Completion Date :||September 22, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Gua sha group
do gua sha for the subjects
Other: Gua sha
Scrape the skin around the knee joint
Active Comparator: control group
give hot pack for the subjects
Other: hot pack
- Visual Analogue Scale [ Time Frame: 10 Days ]To assess the pain degree. Scale: 0~100 mm, higher scores, higher pain . Counted by each time recording.
- Lower Extremity Functional Scale [ Time Frame: 10 Days ]
Evaluate the functional impairment of a patient with a disorder of one or both lower extremities.
Scale: 0~80, higher scores, higher lower extremity function Counted by each time recording.
- Short Form-12 Health Survey [ Time Frame: 3 Days ]Evaluate the health-related quality of life, use SF-12 questionnaire. Scale: 0~100, higher scores, better life quality. Counted by each time recording and using mode conversion to get final scale.
- Ultrasound scans of knee [ Time Frame: 3 Days ]
To observe the tissue of knee joint, compare quadriceps muscle changes and tendon thickness before and after treatment.
No special measure, just take picture of ultrasound scans and compare the picture.
- surface temperature [ Time Frame: 2 hours ]To evaluate the knee joint surface temperature before and after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821194
|Contact: Fang-Pey Chen, MDfirstname.lastname@example.org|
|Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 112|
|Contact: Fang-Pey Chen, MD|
|Study Chair:||Fang-Pey Chen, MD||Center for Traditional Medicine, Taipei Veterans General Hospital|