Hip OsteoarthritisNCT05224674
Comparative Effects of Focused and Radial Shock-Wave Therapies in Hip Osteoarthritis.
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Hip Osteoarthritis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
There is no scientific study in the literature regarding the use of shock wave therapy in hip osteoarthritis. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in hip osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Extracorporeal Shock Wave Therapy (ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Sep 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral or bilateral hip osteoarthritis
Who cannot join
- other disorders that are contraindications for shockwave therapy, not have received ESWT treatment before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Focused (Large Focused) and Radial (Controlled Unfocused) Shock-Wave Therapies in Hip Osteoarthritis.
There is no scientific study in the literature regarding the use of shock wave therapy in hip osteoarthritis. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in hip osteoarthritis.
- Conditions
- Hip Osteoarthritis
- Being tested
- Extracorporeal Shock Wave Therapy (ESWT)
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy (ESWT)Device
The ESWT device is product of Elettronica Pagani, Italy.
| Study group | Role | What they receive |
|---|---|---|
| Large-Focused Extracorporeal Shock Wave Therapy | Active comparator | Not described Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Controlled-Unfocused Extracorporeal Shock Wave Therapy | Active comparator | Not described Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Sham Extracorporeal Shock Wave Therapy | Sham comparator | Not described Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Measured: at baseline.
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Measured: 4 weeks after baseline.
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Measured: 8 weeks after baseline.
Secondary outcomes (3)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Measured: at baseline.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Measured: 4 weeks after baseline.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
24-item questionnaire for osteoarthritis, in the range of 0 to 96, higher scores mean a worse outcome
Measured: 8 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Jan 2022
- Primary completion29 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Şah, Yuzuncu Yil University
- Investigators
- Volkan Şah, Principal investigator, Yüzüncü Yıl Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224674
- Sponsor's protocol ID
- Van Yuzuncu Yil University
- Status last verified
- Nov 2022
- First submitted
- 18 Jan 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Focused (Large Focused) and Radial (Controlled Unfocused) Shock-Wave Therapies in Hip Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05224674
- Acronym / sponsor ID
- Van Yuzuncu Yil University
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- 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.
There is no scientific study in the literature regarding the use of shock wave therapy in hip osteoarthritis. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in hip osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Large-Focused Extracorporeal Shock Wave Therapy | Active comparator | Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Controlled-Unfocused Extracorporeal Shock Wave Therapy | Active comparator | Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Sham Extracorporeal Shock Wave Therapy | Sham comparator | Device: Extracorporeal Shock Wave Therapy (ESWT) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral or bilateral hip osteoarthritis
Key exclusion criteria (1 listed)
- other disorders that are contraindications for shockwave therapy, not have received ESWT treatment before
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 |
|---|---|---|
| Extracorporeal Shock Wave Therapy (ESWT)The ESWT device is product of Elettronica Pagani, Italy. | Device | Controlled-Unfocused Extracorporeal Shock Wave Therapy, Large-Focused Extracorporeal Shock Wave Therapy, Sham Extracorporeal Shock Wave Therapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: at baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
Visual Analogue Scale (VAS)
Time frame: 4 weeks after baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
Visual Analogue Scale (VAS)
Time frame: 8 weeks after baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
3 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: at baseline.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 4 weeks after baseline.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 8 weeks after baseline.
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 29 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Volkan Şah principal investigator
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Hip Osteoarthritis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 29 Nov 2022. 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 Turkey (Türkiye). 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?
Visual Analogue Scale (VAS) (time frame: at baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2022.