Greater Trochanteric Pain Syndrome of Both Lower LimbsGTPSSWEXNCT06248905
Shock Wave Therapy Plus Exercise in GTPS
A study testing Rehabilitation program based on the strengthening of gluteal muscles and Extracorporeal shock wave therapy in people with Greater Trochanteric Pain Syndrome of Both Lower Limbs, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The aim of this randomized controlled study is to investigate if the sequential administration of focused shock wave therapy and of a rehabilitation program based on the strengthening of gluteal muscles is more effective than a standard shock wave treatment for greater trochanteric pain syndrome Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Greater Trochanteric Pain Syndrome of Both Lower Limbs
- What is being tested?
- Rehabilitation program based on the strengthening of gluteal muscles and Extracorporeal shock wave therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral hip pain of four weeks or longer duration
- Pain to palpation in the greater trochanteric area at physical examination
- Pain in hip end-range abduction/rotation/adduction at physical examination
- Gluteal tendinopathy, in absence of full thickness tears at a sonographic examination of the gluteal tendons
- Adult age and written informed consent
Who cannot join
- No hip osteoarthritis, diagnosed according to Altman's criteria
- No history of knee osteoarthritis
- No history of rheumatologic diseases
- No previous fractures or surgery in the affected limb
- No clinical signs of lumbar radiculopathy at physical examination
- No corticosteroid injections, since the onset of the current pain episode
- No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shock Wave Therapy Combined With Strengthening Exercise of Hip Abductor Muscles in the Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial
The aim of this randomized controlled study is to investigate if the sequential administration of focused shock wave therapy and of a rehabilitation program based on the strengthening of gluteal muscles is more effective than a standard shock wave treatment for greater trochanteric pain syndrome
- Being tested
- Rehabilitation program based on the strengthening of gluteal muscles, Extracorporeal shock wave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation program based on the strengthening of gluteal musclesOther
Physiotherapy program (8 weeks)
Extracorporeal shock wave therapyOther
Focused shock wave therapy (3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| exercise plus shockwaves | Experimental | Enrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator.
Focusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus.
Dosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz).
The experimental group will then start a physiotherapy program for the following 8 weeks. The program is made up of strengthening and stretching exercises of gluteal muscles, planned to be daily performed at home. Four supervised physiotherapy session will be planned on week 0-1-2-4, during which the exercise loading will be implemented. Receives: Other: Rehabilitation program based on the strengthening of gluteal muscles; Other: Extracorporeal shock wave therapy |
| shockwaves | Active comparator | Enrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator.
Focusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus.
Dosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz). Receives: Other: Extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS Pain
Change in lateral hip pain measured by the Numeric Rating Scale (NRS)
Measured: 6 months
Secondary outcomes (3)
EQ5D Quality of life
Change in quality of life measured by EQ-5D-3L
Measured: 12 months
VISA-G Disability
Change in disability measured by VISA-G questionnaire
Measured: 12 months
Functional capacity (strength of gluteal muscles)
Change in functional capacity measured by MRC scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start26 Jan 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Trochanteric Pain Syndrome of Both Lower LimbsStudies 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
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ettore Carlis, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248905
- Sponsor's protocol ID
- 0005201/24
- Acronym
- GTPSSWEX
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave Therapy Combined With Strengthening Exercise of Hip Abductor Muscles in the Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06248905
- Acronym / sponsor ID
- GTPSSWEX / 0005201/24
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 8 Feb 2024 (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 aim of this randomized controlled study is to investigate if the sequential administration of focused shock wave therapy and of a rehabilitation program based on the strengthening of gluteal muscles is more effective than a standard shock wave treatment for greater trochanteric pain syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise plus shockwaves | Experimental | Other: Rehabilitation program based on the strengthening of gluteal muscles, Other: Extracorporeal shock wave therapyEnrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator. Focusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus. Dosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz). The experimental group will then start a physiotherapy program for the following 8 weeks. The program is made up of strengthening and stretching exercises of gluteal muscles, planned to be daily performed at home. Four supervised physiotherapy session will be planned on week 0-1-2-4, during which the exercise loading will be implemented. |
| shockwaves | Active comparator | Other: Extracorporeal shock wave therapyEnrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator. Focusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus. Dosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral hip pain of four weeks or longer duration
- Pain to palpation in the greater trochanteric area at physical examination
- Pain in hip end-range abduction/rotation/adduction at physical examination
- Gluteal tendinopathy, in absence of full thickness tears at a sonographic examination of the gluteal tendons
- Adult age and written informed consent
Key exclusion criteria (7 listed)
- No hip osteoarthritis, diagnosed according to Altman's criteria
- No history of knee osteoarthritis
- No history of rheumatologic diseases
- No previous fractures or surgery in the affected limb
- No clinical signs of lumbar radiculopathy at physical examination
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 |
|---|---|---|
| Rehabilitation program based on the strengthening of gluteal musclesPhysiotherapy program (8 weeks) | Other | exercise plus shockwaves |
| Extracorporeal shock wave therapyFocused shock wave therapy (3 weeks) | Other | exercise plus shockwaves, shockwaves |
Primary outcome
NRS Pain
Time frame: 6 months
Change in lateral hip pain measured by the Numeric Rating Scale (NRS)
3 secondary outcomes
EQ5D Quality of life
Time frame: 12 months
VISA-G Disability
Time frame: 12 months
Functional capacity (strength of gluteal muscles)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Related trials for Greater Trochanteric Pain Syndrome of Both Lower Limbs
Recruiting
ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain
Greater Trochanteric Pain Syndrome, Greater Trochanteric Pain Syndrome of Both Lower Limbs
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program based on the strengthening of gluteal muscles and Extracorporeal shock wave therapy in people with Greater Trochanteric Pain Syndrome of Both Lower Limbs, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 8 Feb 2024. 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 Italy. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
NRS Pain (time frame: 6 months). 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 8 Feb 2024.