TendinopathyNCT03142971
Shock Wave Therapy for Lateral Hip Pain, Caused by Tendon Pathology
A study testing focused shock wave therapy and ultrasound therapy in people with Tendinopathy, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
Trial summary
The aim of this randomized controlled study is to investigate if focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- focused shock wave therapy and ultrasound therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to 4 May 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- duration of lateral hip pain of six weeks or longer,
- normal passive hip range of movement (ROM),
- sonographic evidence of gluteal tendinopathy at their insertional site at the greater trochanter
Who cannot join
- general contraindication to extracorporeal shock wave therapy (pacemaker, pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area),
- history of rheumatologic disease,
- previous fractures or surgery in the affected limb,
- full thickness tear of the gluteal tendons,
- osteoarthritis of the hip (with ROM limitation),
- clinical signs of lumbar radiculopathy,
- corticosteroid injections or other conservative therapies (except pharmacological pain treatments) since the onset of the current pain episode.
About this study
Official title: Focused Extracorporeal Shock Wave Therapy for Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial
The aim of this randomized controlled study is to investigate if focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy.
- Conditions
- Tendinopathy
- Being tested
- focused shock wave therapy, ultrasound therapy
- Keywords
- Shock waves, Greater trochanteric pain syndrome
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused shock wave therapyProcedure or surgery
ultrasound therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention:f-ESWT (focused shock wave therapy) | Experimental | In the study-group, a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf) was used . At the beginning of each treatment session, the enthesis of the gluteal tendons at the greater trochanter (at the anterior half of its lateral facet) was targeted through a non-inline sonographic focusing, using a linear probe (7.5-12 MHz) connected to an ultrasound scanner (ESAOTE MYLAB FIVE, Genova and Florence, Italy). All patients received 1800 pulses (frequency=4Hz) of an energy flux density of 0.15 mJ/mm2 once a week for three consecutive weeks. At the first treatment session, the energy flux density was gradually increased from 0.05 to 0.15 mJ/mm2 during the first 500 pulses. Receives: Procedure: focused shock wave therapy |
| Intervention:UST (ultrasound therapy) | Active comparator | In the control-group, we used a mono-frequency device (ROLAND, RT-20 series, frequency=1MHz). We treated an area of 5cm2, softly moving the US-probe around the most painful point of the greater trochanter at the clinical palpation. UST was supplied in a continuous modality, with an intensity of 1.5 W/cm2, for ten consecutive daily sessions of ten minutes each. Receives: Procedure: ultrasound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
p-NRS
Change from baseline p-NRS (pain-on-movement numeric rating scale) at 2 months and at 6 months.
Measured: Baseline, at two months, at six months
LEFS score
Change from baseline LEFS (Lower extremity functional scale) total score at 2 months and at 6 months
Measured: Baseline, at two months, at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startMar 2013
- Primary completion4 May 2016
- Study completion4 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- 50 participants (actual)
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
- NCT03142971
- Sponsor's protocol ID
- 20130001077
- Status last verified
- May 2017
- First submitted
- 28 Apr 2017
- Last updated
- 10 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Extracorporeal Shock Wave Therapy for Greater Trochanteric Pain Syndrome With Gluteal Tendinopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03142971
- Acronym / sponsor ID
- 20130001077
- Conditions
- Tendinopathy
- Keywords
- Shock waves, Greater trochanteric pain syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 4 May 2016 (actual)
- Study completion
- 4 May 2016 (actual)
- First posted
- 8 May 2017 (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 focal shock wave is an effective treatment, with respect to hip pain and lower limb function, in a population affected by greater trochanteric pain syndrome with gluteal tendinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention:f-ESWT (focused shock wave therapy) | Experimental | Procedure: focused shock wave therapyIn the study-group, a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf) was used . At the beginning of each treatment session, the enthesis of the gluteal tendons at the greater trochanter (at the anterior half of its lateral facet) was targeted through a non-inline sonographic focusing, using a linear probe (7.5-12 MHz) connected to an ultrasound scanner (ESAOTE MYLAB FIVE, Genova and Florence, Italy). All patients received 1800 pulses (frequency=4Hz) of an energy flux density of 0.15 mJ/mm2 once a week for three consecutive weeks. At the first treatment session, the energy flux density was gradually increased from 0.05 to 0.15 mJ/mm2 during the first 500 pulses. |
| Intervention:UST (ultrasound therapy) | Active comparator | Procedure: ultrasound therapyIn the control-group, we used a mono-frequency device (ROLAND, RT-20 series, frequency=1MHz). We treated an area of 5cm2, softly moving the US-probe around the most painful point of the greater trochanter at the clinical palpation. UST was supplied in a continuous modality, with an intensity of 1.5 W/cm2, for ten consecutive daily sessions of ten minutes each. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- duration of lateral hip pain of six weeks or longer,
- normal passive hip range of movement (ROM),
- sonographic evidence of gluteal tendinopathy at their insertional site at the greater trochanter
Key exclusion criteria (7 listed)
- general contraindication to extracorporeal shock wave therapy (pacemaker, pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area),
- history of rheumatologic disease,
- previous fractures or surgery in the affected limb,
- full thickness tear of the gluteal tendons,
- osteoarthritis of the hip (with ROM limitation),
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 |
|---|---|---|
| focused shock wave therapy | Procedure or surgery | Intervention:f-ESWT (focused shock wave therapy) |
| ultrasound therapy | Procedure or surgery | Intervention:UST (ultrasound therapy) |
Primary outcome
p-NRS
Time frame: Baseline, at two months, at six months
Change from baseline p-NRS (pain-on-movement numeric rating scale) at 2 months and at 6 months.
LEFS score
Time frame: Baseline, at two months, at six months
Change from baseline LEFS (Lower extremity functional scale) total score at 2 months and at 6 months
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 10 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing focused shock wave therapy and ultrasound therapy in people with Tendinopathy, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
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 3 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: finished, as of the sponsor's last update on 10 May 2017. 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?
p-NRS (time frame: Baseline, at two months, at six months). 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?
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 10 May 2017.