Extracorporeal Shockwave Therapy for Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Shockwave Therapy
• Intervention / Treatment: Device: shockwave therapy; Other: PT; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33004
    • Taoyuan General Hospital, Ministry of Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: shockwave therapy; 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	Device: shockwave therapy; Intervention with shockwave therapy; Other: PT; Physical therapy 3 times per week for 3 weeks
PLACEBO_COMPARATOR: placebo; 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	Other: PT; Physical therapy 3 times per week for 3 weeks; Other: placebo; sham shockwave therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC score by Chinese version NRS 3.1		Change from baseline to week 3 and week 4
six minute walk test	The distance covered in meters of six minute walk test	Change from baseline to week 3 and week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual analog scale (VAS)	Change from baseline to week 3 and week 4

Collaborators and Investigators

• Sponsor: Taoyuan General Hospital
• Investigators: Principal Investigator: Huan-Jui Yeh, TaoYuan General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2017
• Primary Completion (ACTUAL): February 2, 2018
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (ESTIMATE): February 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: knee osteoarthritis; shockwave therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: TYGH105013

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