search
Back to results

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

Primary Purpose

Pain, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Gua sha
hot pack
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Chronic focused on measuring pain relief, complementary and alternative therapy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gua sha group

control group

Arm Description

do gua sha for the subjects

give hot pack for the subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ultrasound scans of knee
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
To evaluate the knee joint surface temperature before and after treatment.

Full Information

First Posted
December 20, 2018
Last Updated
June 8, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT03821194
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
September 22, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
pain relief, complementary and alternative therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
chronic knee joint pain patients
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gua sha group
Arm Type
Experimental
Arm Description
do gua sha for the subjects
Arm Title
control group
Arm Type
Active Comparator
Arm Description
give hot pack for the subjects
Intervention Type
Other
Intervention Name(s)
Gua sha
Intervention Description
Scrape the skin around the knee joint
Intervention Type
Other
Intervention Name(s)
hot pack
Intervention Description
hot pack
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
To assess the pain degree. Scale: 0~100 mm, higher scores, higher pain . Counted by each time recording.
Time Frame
10 Days
Title
Lower Extremity Functional Scale
Description
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.
Time Frame
10 Days
Title
Short Form-12 Health Survey
Description
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.
Time Frame
3 Days
Secondary Outcome Measure Information:
Title
Ultrasound scans of knee
Description
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.
Time Frame
3 Days
Title
surface temperature
Description
To evaluate the knee joint surface temperature before and after treatment.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-Pey Chen, MD
Phone
+886-2-2875-7453
Email
fpchen@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang-Pey Chen, MD
Organizational Affiliation
Center for Traditional Medicine, Taipei Veterans General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang-Pey Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28795010
Citation
Patel DR, Villalobos A. Evaluation and management of knee pain in young athletes: overuse injuries of the knee. Transl Pediatr. 2017 Jul;6(3):190-198. doi: 10.21037/tp.2017.04.05.
Results Reference
background
PubMed Identifier
22147711
Citation
Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004.
Results Reference
background
PubMed Identifier
24997734
Citation
Werner S. Anterior knee pain: an update of physical therapy. Knee Surg Sports Traumatol Arthrosc. 2014 Oct;22(10):2286-94. doi: 10.1007/s00167-014-3150-y. Epub 2014 Jul 6.
Results Reference
background
PubMed Identifier
23230089
Citation
Iagnocco A, Naredo E. Osteoarthritis: research update and clinical applications. Rheumatology (Oxford). 2012 Dec;51 Suppl 7:vii2-5. doi: 10.1093/rheumatology/kes328.
Results Reference
background
PubMed Identifier
12605951
Citation
Cowan DT, Fitzpatrick JM, Roberts JD, While AE, Baldwin J. The assessment and management of pain among older people in care homes: current status and future directions. Int J Nurs Stud. 2003 Mar;40(3):291-8. doi: 10.1016/s0020-7489(02)00087-1.
Results Reference
background
PubMed Identifier
24146995
Citation
MacPherson H, Maschino AC, Lewith G, Foster NE, Witt CM, Vickers AJ; Acupuncture Trialists' Collaboration. Characteristics of acupuncture treatment associated with outcome: an individual patient meta-analysis of 17,922 patients with chronic pain in randomised controlled trials. PLoS One. 2013 Oct 11;8(10):e77438. doi: 10.1371/journal.pone.0077438. eCollection 2013. Erratum In: PLoS One. 2013;8(12). doi:10.1371/annotation/23629d97-3b72-474b-9d89-c7198ba43d60. Witt, Claudia [corrected to Witt, Claudia M].
Results Reference
background
Citation
WHO. WHO Traditional Medicine Strategy 2014-2023. WHO Library Cataloguing-inPublication Data. 2013.
Results Reference
background
PubMed Identifier
15127982
Citation
Sun C, Desai GJ, Pucci DS, Jew S. Musculoskeletal disorders: does the osteopathic medical profession demonstrate its unique and distinctive characteristics? J Am Osteopath Assoc. 2004 Apr;104(4):149-55.
Results Reference
background
PubMed Identifier
17905355
Citation
Nielsen A, Knoblauch NT, Dobos GJ, Michalsen A, Kaptchuk TJ. The effect of Gua Sha treatment on the microcirculation of surface tissue: a pilot study in healthy subjects. Explore (NY). 2007 Sep-Oct;3(5):456-66. doi: 10.1016/j.explore.2007.06.001.
Results Reference
background
PubMed Identifier
19118794
Citation
Nielsen A. Gua sha research and the language of integrative medicine. J Bodyw Mov Ther. 2009 Jan;13(1):63-72. doi: 10.1016/j.jbmt.2008.04.045. Epub 2008 Jul 17.
Results Reference
background
PubMed Identifier
3649128
Citation
Hautman MA. Self-care responses to respiratory illnesses among Vietnamese. West J Nurs Res. 1987 May;9(2):223-43. doi: 10.1177/019394598700900205. No abstract available.
Results Reference
background
PubMed Identifier
21276190
Citation
Braun M, Schwickert M, Nielsen A, Brunnhuber S, Dobos G, Musial F, Ludtke R, Michalsen A. Effectiveness of traditional Chinese "gua sha" therapy in patients with chronic neck pain: a randomized controlled trial. Pain Med. 2011 Mar;12(3):362-9. doi: 10.1111/j.1526-4637.2011.01053.x. Epub 2011 Jan 28.
Results Reference
background
PubMed Identifier
28619301
Citation
Yuen JWM, Tsang WWN, Tse SHM, Loo WTY, Chan ST, Wong DLY, Chung HHY, Tam JKK, Choi TKS, Chiang VCL. The effects of Gua sha on symptoms and inflammatory biomarkers associated with chronic low back pain: A randomized active-controlled crossover pilot study in elderly. Complement Ther Med. 2017 Jun;32:25-32. doi: 10.1016/j.ctim.2017.03.010. Epub 2017 Mar 21.
Results Reference
background
PubMed Identifier
22928824
Citation
Lauche R, Wubbeling K, Ludtke R, Cramer H, Choi KE, Rampp T, Michalsen A, Langhorst J, Dobos GJ. Randomized controlled pilot study: pain intensity and pressure pain thresholds in patients with neck and low back pain before and after traditional East Asian "gua sha" therapy. Am J Chin Med. 2012;40(5):905-17. doi: 10.1142/S0192415X1250067X.
Results Reference
background
PubMed Identifier
24187865
Citation
Wang Y, Yang L, Yang J, Yang J, Liu Z, Chen F, Liu D, Yuan H, Wang L. Curative effect of scraping therapies on lumbar muscle strain. J Tradit Chin Med. 2013 Aug;33(4):455-60. doi: 10.1016/s0254-6272(13)60148-x.
Results Reference
background
PubMed Identifier
20220605
Citation
Chiu JY, Gau ML, Kuo SY, Chang YH, Kuo SC, Tu HC. Effects of Gua-Sha therapy on breast engorgement: a randomized controlled trial. J Nurs Res. 2010 Mar;18(1):1-10. doi: 10.1097/JNR.0b013e3181ce4f8e.
Results Reference
background
PubMed Identifier
21616064
Citation
Chan ST, Yuen JW, Gohel MD, Chung CP, Wong HC, Kwong KK. Guasha-induced hepatoprotection in chronic active hepatitis B: a case study. Clin Chim Acta. 2011 Aug 17;412(17-18):1686-8. doi: 10.1016/j.cca.2011.05.009. Epub 2011 May 13.
Results Reference
background
PubMed Identifier
25098257
Citation
Tu WZ, Cheng RD, Hu J, Wang JZ, Lin HY, Zou EM, Wang WS, Lou XF, Jiang SH. Combination treatment with Gua Sha and Blood-letting causes attenuation of systemic inflammation, activated coagulation, tissue ischemia and injury during heatstroke in rats. Chin J Integr Med. 2015 Aug;21(8):610-7. doi: 10.1007/s11655-014-1816-4. Epub 2014 Aug 7.
Results Reference
background
PubMed Identifier
19718012
Citation
Kwong KK, Kloetzer L, Wong KK, Ren JQ, Kuo B, Jiang Y, Chen YI, Chan ST, Young GS, Wong ST. Bioluminescence imaging of heme oxygenase-1 upregulation in the Gua Sha procedure. J Vis Exp. 2009 Aug 28;(30):1385. doi: 10.3791/1385.
Results Reference
background
PubMed Identifier
22462238
Citation
Xu QY, Yang JS, Yang L, Wang YY. Effects of different scraping techniques on body surface blood perfusion volume and local skin temperature of healthy subjects. J Tradit Chin Med. 2011 Dec;31(4):316-20. doi: 10.1016/s0254-6272(12)60011-9.
Results Reference
background
PubMed Identifier
26554281
Citation
Jones BQ, Covey CJ, Sineath MH Jr. Nonsurgical Management of Knee Pain in Adults. Am Fam Physician. 2015 Nov 15;92(10):875-83.
Results Reference
background
PubMed Identifier
24267149
Citation
Simon LS. Nonsteroidal anti-inflammatory drugs and their risk: a story still in development. Arthritis Res Ther. 2013;15 Suppl 3(Suppl 3):S1. doi: 10.1186/ar4173. Epub 2013 Jul 24.
Results Reference
background
PubMed Identifier
10201543
Citation
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs