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Completed

NCT Number: NCT03048773

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan, 33004, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shockwave therapy

Device

Intervention with shockwave therapy

PT

Other

Physical therapy 3 times per week for 3 weeks

Placebo

Other

sham shockwave therapy

Primary outcomes

  1. WOMAC score by Chinese version NRS 3.1

    Time frame: Change from baseline to week 3 and week 4

  2. six minute walk test

    Time frame: Change from baseline to week 3 and week 4

    The distance covered in meters of six minute walk test

Secondary outcomes

  1. Visual analog scale (VAS)

    Time frame: Change from baseline to week 3 and week 4

Sponsors and collaborators

Lead sponsor

Taoyuan General Hospital

Other Gov

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2017
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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