NCT03048773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

January 24, 2017

Last Update Submit

November 6, 2020

Conditions

Shockwave TherapyKnee Osteoarthritis

Keywords

shockwave therapyknee osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Visual analog scale (VAS)

    Change from baseline to week 3 and week 4

Study Arms (2)

shockwave therapy

EXPERIMENTAL

1. 0.24mJ/mm2，1600 shots over 8 assigned sites of single knee with jelly between applicator pad (20) and handpiece 2. Physical therapy with TENS + MF + stretching + strengthening exercise, 3 times per week for 3 weeks

Device: shockwave therapyOther: PT

placebo

PLACEBO COMPARATOR

1. 0.24mJ/mm2，1600 shots over 8 assigned sites of single knee without jelly between applicator pad (20) and handpiece 2. Physical therapy with TENS + MF + stretching + strengthening exercise, 3 times per week for 3 weeks

Other: PTOther: placebo

Interventions

shockwave therapyDEVICE

Intervention with shockwave therapy

shockwave therapy
PTOTHER

Physical therapy 3 times per week for 3 weeks

placeboshockwave therapy
placeboOTHER

sham shockwave therapy

placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan District, 33004, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 34915541DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Huan-Jui Yeh

    Taoyuan General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participant, Investigator, Outcomes Assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2017

First Posted

February 9, 2017

Study Start

March 2, 2017

Primary Completion

February 2, 2018

Study Completion

June 30, 2018

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)