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

NCT03821194 | Unknown DMC

• 1 other identifier: 2018-08-030A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

pain relief; complementary and alternative therapy

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale

  To assess the pain degree. Scale: 0\~100 mm, higher scores, higher pain . Counted by each time recording.

  10 Days

• 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

• 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 Outcomes (2)

• Ultrasound scans of knee

  3 Days

• surface temperature

  2 hours

Study Arms (2)

Gua sha group

EXPERIMENTAL

do gua sha for the subjects

Other: Gua sha

control group

ACTIVE COMPARATOR

give hot pack for the subjects

Other: hot pack

Interventions

Gua sha OTHER

Scrape the skin around the knee joint

Gua sha group

hot pack OTHER

hot pack

control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Those aged 20-60 years old
• 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.
• Visual pain score (VAS) ≧30 (mm) for unilateral or bilateral knee joints
• Non-steroidal anti-inflammatory drugs, analgesics, and Chinese herbal medicines for the treatment of knee joint pain
• Non-severe degenerative arthritis (Kellgren-Lawrence scale knee arthritis grade 2 or less)

You may not qualify if:

• 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
• Pregnancy
• BMI value is greater than 27 KG/m2
• People with cardiovascular disease or hemophilia
• Patients with gout, rheumatism and rheumatoid arthritis
• Diabetic patients with knee arthritis, patients with dry arthritis
• Patients with malignant tumors
• Those who are allergic to Vaseline products

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

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MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fang-Pey Chen, MD

  Center for Traditional Medicine, Taipei Veterans General Hospital

  STUDY CHAIR

Central Study Contacts

Fang-Pey Chen, MD

CONTACT

+886-2-2875-7453; fpchen@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: chronic knee joint pain patients

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 29, 2019
• Study Start: January 25, 2019
• Primary Completion: September 22, 2019
• Study Completion: December 31, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)