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

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ClinicalTrials.gov Identifier: NCT03821194
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pain, Chronic Other: Gua sha Other: hot pack Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: chronic knee joint pain patients
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Chronic Pain Relief Over Knee Joint Area by Gua Sha Therapy
Estimated Study Start Date : January 25, 2019
Estimated Primary Completion Date : September 22, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.


Secondary Outcome Measures :
  1. 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.


  2. surface temperature [ Time Frame: 2 hours ]
    To evaluate the knee joint surface temperature before and after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821194


Contacts
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Contact: Fang-Pey Chen, MD +886-2-2875-7453 fpchen@vghtpe.gov.tw

Locations
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Taiwan
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan, 112
Contact: Fang-Pey Chen, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Chair: Fang-Pey Chen, MD Center for Traditional Medicine, Taipei Veterans General Hospital

Publications:
WHO. WHO Traditional Medicine Strategy 2014-2023. WHO Library Cataloguing-inPublication Data. 2013.

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03821194     History of Changes
Other Study ID Numbers: 2018-08-030A
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei Veterans General Hospital, Taiwan:
pain relief
complementary and alternative therapy

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms