Shockwave TherapyNCT03048773
Extracorporeal Shockwave Therapy for Knee Osteoarthritis
A study testing shockwave therapy and PT in people with Shockwave Therapy and Knee Osteoarthritis, run by Taoyuan General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Shockwave Therapy, Knee Osteoarthritis
- What is being tested?
- shockwave therapy and PT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, 33004
About this study
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.
Read more
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.
- Conditions
- Shockwave Therapy, Knee Osteoarthritis
- Being tested
- shockwave therapy, PT, placebo
- Keywords
- shockwave therapy, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shockwave therapyDevice
Intervention with shockwave therapy
PTOther
Physical therapy 3 times per week for 3 weeks
placeboOther
sham shockwave therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: shockwave therapy; Other: 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 Receives: Other: PT; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC score by Chinese version NRS 3.1
Measured: Change from baseline to week 3 and week 4
six minute walk test
The distance covered in meters of six minute walk test
Measured: Change from baseline to week 3 and week 4
Secondary outcomes (1)
Visual analog scale (VAS)
Measured: Change from baseline to week 3 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start2 Mar 2017
- Primary completion2 Feb 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shockwave TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Huan-Jui Yeh, Principal investigator, Taoyuan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048773
- Sponsor's protocol ID
- TYGH105013
- Status last verified
- Nov 2020
- First submitted
- 24 Jan 2017
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34915541
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shockwave Therapy for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03048773
- Acronym / sponsor ID
- TYGH105013
- Conditions
- Shockwave Therapy, Knee Osteoarthritis
- Keywords
- shockwave therapy, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Taoyuan General HospitalOther government
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shockwave therapy | Experimental | Device: shockwave therapy, Other: PT1. 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 |
| placebo | Placebo comparator | Other: PT, Other: placebo1. 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shockwave therapyIntervention with shockwave therapy | Device | shockwave therapy |
| PTPhysical therapy 3 times per week for 3 weeks | Other | placebo, shockwave therapy |
| placebosham shockwave therapy | Other | placebo |
Primary outcome
WOMAC score by Chinese version NRS 3.1
Time frame: Change from baseline to week 3 and week 4
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
1 secondary outcome
Visual analog scale (VAS)
Time frame: Change from baseline to week 3 and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 34915541Ho 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.
- Individual participant dataSharing planned: No
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huan-Jui Yeh principal investigator
Taoyuan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shockwave therapy and PT in people with Shockwave Therapy and Knee Osteoarthritis, run by Taoyuan General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC score by Chinese version NRS 3.1 (time frame: Change from baseline to week 3 and week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.