Hip OsteoarthritisNCT04206722
Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis
A study testing Shock Wave Therapy and Ultrasound in people with Hip Osteoarthritis, run by Iuliu Hatieganu University of Medicine and Pharmacy.
Trial summary
The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Shock Wave Therapy and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral or bilateral hip osteoarthritis
Who cannot join
- other disorders that are contraindications for shockwave or ultrasound application
About this study
The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.
Read the detailed description
The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Among them, shockwave therapy is not a new treatment method, and seems to be effective in rotator cuff pathology, tennis elbow, and also on knee osteoarthritis, but few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.
- Conditions
- Hip Osteoarthritis
- Being tested
- Shock Wave Therapy, Ultrasound
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock Wave TherapyDevice
Shock Wave therapy - hip osteoarthritis program
UltrasoundDevice
Ultrasound 0.7W/cm2
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Shock Wave therapy on the affected hip, for 10 days, 1 application every 2 days Receives: Device: Shock Wave Therapy |
| Control group | Active comparator | Ultrasound therapy on the affected hip, for 10 days, 1 application daily Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline Visual Analogue Scale (VAS) score at 10 days and 30 days
10mm to 100mm, higher scores mean a worse outcome
Measured: at baseline, after 10 days, after 30 days
Secondary outcomes (1)
change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 10 days and 30 days
24-item questionnaire for osteoarthritis, higher scores mean a worse outcome
Measured: at baseline, after 10 days, after 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study startJun 2012
- Primary completionDec 2018
- Study completionDec 2018
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciubean Alina Deniza, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Irsay Laszlo, MD, PhD, Study director, University of Medicine and Pharmacy Iuliu Hatieganu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206722
- Sponsor's protocol ID
- UniversitateaMFHIL
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT04206722
- Acronym / sponsor ID
- UniversitateaMFHIL
- Conditions
- Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Dec 2019 (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.
The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.
Detailed description
The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Among them, shockwave therapy is not a new treatment method, and seems to be effective in rotator cuff pathology, tennis elbow, and also on knee osteoarthritis, but few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Shock Wave TherapyShock Wave therapy on the affected hip, for 10 days, 1 application every 2 days |
| Control group | Active comparator | Device: UltrasoundUltrasound therapy on the affected hip, for 10 days, 1 application daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 or ultrasound application
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 |
|---|---|---|
| Shock Wave TherapyShock Wave therapy - hip osteoarthritis program | Device | Treatment group |
| UltrasoundUltrasound 0.7W/cm2 | Device | Control group |
Primary outcome
change from baseline Visual Analogue Scale (VAS) score at 10 days and 30 days
Time frame: at baseline, after 10 days, after 30 days
10mm to 100mm, higher scores mean a worse outcome
1 secondary outcome
change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 10 days and 30 days
Time frame: at baseline, after 10 days, after 30 days
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 20 Dec 2019.
- Individual participant dataSharing planned: Undecided. upon request
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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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.
Irsay Laszlo, MD, PhD study director
University of Medicine and Pharmacy Iuliu Hatieganu
Questions about this trial
What is this clinical trial studying?
A study testing Shock Wave Therapy and Ultrasound in people with Hip Osteoarthritis, run by Iuliu Hatieganu University of Medicine and Pharmacy.
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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
change from baseline Visual Analogue Scale (VAS) score at 10 days and 30 days (time frame: at baseline, after 10 days, after 30 days). 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 20 Dec 2019.