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

Not Applicable

• Conditions: Pain, Chronic
• Interventions: Other: Gua sha; Other: hot pack

• Registration Number: NCT03821194
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-20
• Study Start: 2019-01-25
• Study First Submitted QC: 2019-01-27
• Study First Posted: 2019-01-29
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-08
• Last Update Posted: 2019-06-11
• Primary Completion: 2019-09-22
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gua sha group	Gua sha	do gua sha for the subjects
control group	hot pack	give hot pack for the subjects

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	10 Days	To assess the pain degree. Scale: 0\~100 mm, higher scores, higher pain . Counted by each time recording.
Short Form-12 Health Survey	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.
Lower Extremity Functional Scale	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.

Secondary Outcome Measures

Name	Time	Method
Ultrasound scans of knee	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	2 hours	To evaluate the knee joint surface temperature before and after treatment.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan