The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy

Pain, Chronic Clinical Trial

Official title:

The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821194
• Other study ID #: 2018-08-030A
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Fang-Pey Chen, MD
• Phone: +886-2-2875-7453
• Email: fpchen[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective:

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.

Expected results:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: September 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Those aged 20-60 years old

2. There are at least three pains in the unilateral or bilateral knee joints (up and down steps, squats, running, squatting, jumping, walking, and sedentary for a long time), and the pain lasts for at least one month.

3. Visual pain score (VAS) ?30 (mm) for unilateral or bilateral knee joints

4. Non-steroidal anti-inflammatory drugs, analgesics, and Chinese herbal medicines for the treatment of knee joint pain

5. Non-severe degenerative arthritis (Kellgren-Lawrence scale knee arthritis grade 2 or less)

Exclusion Criteria:

1. thighs, knee joints, calf areas, those who have undergone surgery or are expected to have surgery, those who have been traumatized within the last month, and those who have wounds, ulcers, infections or other skin diseases within two weeks

2. Pregnancy

3. BMI value is greater than 27 KG/m2

4. People with cardiovascular disease or hemophilia

5. Patients with gout, rheumatism and rheumatoid arthritis

6. Diabetic patients with knee arthritis, patients with dry arthritis

7. Patients with malignant tumors

8. Those who are allergic to Vaseline products

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Other:
• Gua sha
Scrape the skin around the knee joint
• hot pack
hot pack

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	To assess the pain degree. Scale: 0~100 mm, higher scores, higher pain . Counted by each time recording.	10 Days
Primary	Lower Extremity Functional Scale	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.	10 Days
Primary	Short Form-12 Health Survey	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.	3 Days
Secondary	Ultrasound scans of knee	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.	3 Days
Secondary	surface temperature	To evaluate the knee joint surface temperature before and after treatment.	2 hours