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Extracorporeal Shockwave Therapy for Knee Osteoarthritis

Primary Purpose

Shockwave Therapy, Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
shockwave therapy
PT
placebo
Sponsored by
Taoyuan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shockwave Therapy focused on measuring shockwave therapy, knee osteoarthritis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient at Taoyuan general hospital rehabilitation outpatient department during 2017/01/01 ~ 2018/12/31
  2. Diagnosis with knee osteoarthritis (ACR criteria or Kellgren and Lawrence grading II to IV)
  3. Suitable for shockwave therapy and physical therapy with (TENS + MF + stretching + strengthening exercise)
  4. Visual analog scale(VAS) ≧ 4

Exclusion Criteria:

  1. Not suitable for shockwave therapy, including acute infection, osteomyelitis, coagulopathy, use of anticoagulants, pregnant women, patients with a pacemaker or implantable cardiac defibrillator
  2. Patients who can't understand Chinese, including aphasia or dementia
  3. Patient who can't receive 4 weeks of therapy
  4. Patient who can't walk due to peripheral neuropathy or central nerve system diseases
  5. Total knee arthroplasty
  6. Shockwave therapy of knee for the prior 3 months
  7. Skin defect or soft tissue infection over symptomatic knee
  8. Other cause of knee pain which can't treat with physical therapy, including: rheumatoid arthritis, infection, fracture, ligament disruption

Sites / Locations

  • Taoyuan General Hospital, Ministry of Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

shockwave therapy

placebo

Arm Description

0.24mJ/mm2,1600 shots over 8 assigned sites of single knee with jelly between applicator pad (20) and handpiece Physical therapy with TENS + MF + stretching + strengthening exercise, 3 times per week for 3 weeks

0.24mJ/mm2,1600 shots over 8 assigned sites of single knee without jelly between applicator pad (20) and handpiece Physical therapy with TENS + MF + stretching + strengthening exercise, 3 times per week for 3 weeks

Outcomes

Primary Outcome Measures

WOMAC score by Chinese version NRS 3.1
six minute walk test
The distance covered in meters of six minute walk test

Secondary Outcome Measures

Visual analog scale (VAS)

Full Information

First Posted
January 24, 2017
Last Updated
November 6, 2020
Sponsor
Taoyuan General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03048773
Brief Title
Extracorporeal Shockwave Therapy for Knee Osteoarthritis
Official Title
Extracorporeal Shockwave Therapy for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
February 2, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taoyuan General Hospital

4. Oversight

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

5. Study Description

Brief Summary
Knee osteoarthritis is a common disease that causes joint pain, stiffness, and movement limitation. Nearly 50% in those 75 years and above are affected. In Taiwan, the reported prevalence was more than 6000 per year. The cause of pain is joint instability and structure changed, including hyaline articular cartilage lost, bony remodeling, capsular stretching and periartcular muscle weakness. Current guidelines for treatment of symptomatic knee osteoarthritis include exercise, anti-inflammatory drugs, transcutaneous electrical stimulation(TENS) and magnetic fields(MF) which reduce pain and improve the patient's quality of life. However, conservative therapies and oral supplements have been evaluated but are without clear efficacy. Prolotherapy is an injection therapy for chronic musculoskeletal pain. One of the hypotheses is stimulating local healing and current study demonstrated clinical benefit for pain and improvement of function. The effects of multi-point injections were more pronounced in several studies than single-point injection. Extracorporeal shock wave is common treatment for kidney stones, has been widely used in soft tissue diseases, such as calcified tendon lesions and plantar fasciitis. The theory of extracorporeal shock wave is energy of high-frequency vibration caused destruction of stones and other hard material and by increasing the rate of vascular regeneration in the injured area and increasing the rate of autologous tissue repair, possible biological processes include increased mesenchymal stem cell proliferation and differentiation, slowing the inflammatory response and antimicrobial efficacy. Current studies have shown equivalent clinical outcomes on calcific rotator cuff tendinopathy among extracorporeal shock wave therapy, sono-guided acupuncture and arthroscopic surgery and the extracorporeal shock wave has the advantage of non-invasive treatment. Taking the advantages of non-invasive treatment of extracorporeal shockwave. We want to design a randomized control trial by multi-point shockwave therapy and physical therapy compared with placebo shockwave therapy and physical therapy. Two randomized controlled trial (RCT) reported improvement in outcomes in response to shockwave therapy but were not methodologically rigorous. The investigators therefore conducted a two-arm RCT to assess the hypothesis that adults with symptomatic knee pain receiving shockwave therapy will report greater improvement in knee-related quality-of-life than sham shockwave therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shockwave Therapy, Knee Osteoarthritis
Keywords
shockwave therapy, knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participant, Investigator, Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shockwave therapy
Arm Type
Experimental
Arm Description
0.24mJ/mm2,1600 shots over 8 assigned sites of single knee with jelly between applicator pad (20) and handpiece Physical therapy with TENS + MF + stretching + strengthening exercise, 3 times per week for 3 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
0.24mJ/mm2,1600 shots over 8 assigned sites of single knee without jelly between applicator pad (20) and handpiece Physical therapy with TENS + MF + stretching + strengthening exercise, 3 times per week for 3 weeks
Intervention Type
Device
Intervention Name(s)
shockwave therapy
Intervention Description
Intervention with shockwave therapy
Intervention Type
Other
Intervention Name(s)
PT
Intervention Description
Physical therapy 3 times per week for 3 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
sham shockwave therapy
Primary Outcome Measure Information:
Title
WOMAC score by Chinese version NRS 3.1
Time Frame
Change from baseline to week 3 and week 4
Title
six minute walk test
Description
The distance covered in meters of six minute walk test
Time Frame
Change from baseline to week 3 and week 4
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Time Frame
Change from baseline to week 3 and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient at Taoyuan general hospital rehabilitation outpatient department during 2017/01/01 ~ 2018/12/31 Diagnosis with knee osteoarthritis (ACR criteria or Kellgren and Lawrence grading II to IV) Suitable for shockwave therapy and physical therapy with (TENS + MF + stretching + strengthening exercise) Visual analog scale(VAS) ≧ 4 Exclusion Criteria: Not suitable for shockwave therapy, including acute infection, osteomyelitis, coagulopathy, use of anticoagulants, pregnant women, patients with a pacemaker or implantable cardiac defibrillator Patients who can't understand Chinese, including aphasia or dementia Patient who can't receive 4 weeks of therapy Patient who can't walk due to peripheral neuropathy or central nerve system diseases Total knee arthroplasty Shockwave therapy of knee for the prior 3 months Skin defect or soft tissue infection over symptomatic knee Other cause of knee pain which can't treat with physical therapy, including: rheumatoid arthritis, infection, fracture, ligament disruption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huan-Jui Yeh
Organizational Affiliation
Taoyuan General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taoyuan General Hospital, Ministry of Health and Welfare
City
Taoyuan
ZIP/Postal Code
33004
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34915541
Citation
Ho KD, Yang CL, Lo HY, Yeh HJ. Extracorporeal Shockwave Therapy With a Modified Technique on Tendon and Ligament for Knee Osteoarthritis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Jan 1;101(1):11-17. doi: 10.1097/PHM.0000000000001730.
Results Reference
derived

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Extracorporeal Shockwave Therapy for Knee Osteoarthritis

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