Clinical trial NCT03821194: The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy
Official title: The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Keywords: pain relief
complementary and alternative therapy
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: chronic knee joint pain patients
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 10 Days
measure: Lower Extremity Functional Scale
timeFrame: 10 Days
measure: Short Form-12 Health Survey
timeFrame: 3 Days
Secondary outcomes:
measure: Ultrasound scans of knee
timeFrame: 3 Days
measure: surface temperature
timeFrame: 2 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Center for Traditional Medicine, Taipei Veterans General Hospital
name: Fang-Pey Chen, MD
role: STUDY_CHAIR
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