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

June 8, 2019 updated by: Taipei Veterans General Hospital, Taiwan

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
hot pack

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 Days
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.
10 Days
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.
3 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 Days
surface temperature
Time Frame: 2 hours
To evaluate the knee joint surface temperature before and after treatment.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Study Chair: Fang-Pey Chen, MD, Center for Traditional Medicine, Taipei Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 25, 2019

Primary Completion (ANTICIPATED)

September 22, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

January 27, 2019

First Posted (ACTUAL)

January 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 8, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-08-030A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe