Mobility LimitationESTATENCT03338465
Extracorporeal Shockwave Treatment for Greater Trochanteric Pain Syndrome
A study testing Duolith SD1, STORZ Medical, Switzerland with F-SW applicator in people with Mobility Limitation and Trochanteric Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Greater trochanteric pain syndrome (GTPS) is characterized by pain over the greater trochanter, which can refer down the lateral aspect of the hip. Historically, conservative treatments such as rest/activity modification, anti-inflammatory medication, physiotherapy and local corticosteroid injection, are employed as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobility Limitation, Trochanteric Syndrome, Gluteal Tendinitis
- What is being tested?
- Duolith SD1, STORZ Medical, Switzerland with F-SW applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 18 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex, aged oved 18 years, complaining of pain located anterior, lateral or posterior to the great trochanter for more than 3 months.
- Pain while lying on the affected side.
- Local tenderness on palpation of the area of the great trochanter of patients with this symptom as the reason for the consultation.
Who cannot join
- Presence of signs and symptoms of another cause of regional hip pain.
- Presence of hip internal rotation 20° and extension deficit or other range of motion limitation 10º
- Previous hip surgery or use of ESWT for GTPS.
- Acute low back pain
- Vascular, neurologic, rheumatic diseases.
- Tumor in the area or local infection to the hip joint region.
- Pregnancy.
- Severe coagulation disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporeal Shockwave Treatment in the Greater Trochanteric Pain Syndrome. Multicenter, Randomized, Controlled Clinical Trial
Greater trochanteric pain syndrome (GTPS) is characterized by pain over the greater trochanter, which can refer down the lateral aspect of the hip. Historically, conservative treatments such as rest/activity modification, anti-inflammatory medication, physiotherapy and local corticosteroid injection, are employed as first-line management, with some refractory cases requiring surgical intervention.
Acknowledging the unpredictable response and frequent recurrences associated with traditional non operative treatment, the risks and prolonged rehabilitation associated with surgery, and the favorable results from prior studies involving radial pressure waves as a treatment for GTPS, the aim of this study is to investigate the dose-related effect of focalized shockwave treatment at different total energy influx in patients with chronic GTPS.
Read the detailed description
Shockwave therapy (SWT) has been used successfully since the late 1980s for the management of various musculoskeletal disorders including plantar fasciopathy, achilles tendinopathy, shoulder calcific tendinopathy, and lateral epicondylitis. Although there are some negative trials, there are now many randomized, double-blinded, clinical trials that support the use of SWT for the above conditions. Acknowledging the unpredictable response and frequent recurrences associated with traditional non operative treatment, the risks and prolonged rehabilitation associated with surgery, the recognition of gluteal tendinopathy as a potential source of pain, and the favorable results from prior studies involving radial pressure waves as a treatment for GTPS, the aim of this study is to investigate the dose-related effect of shockwave treatment at different total energy by adjusting the energy flux density (EFD) in patients with chronic GTPS. The shockwave has been widely recognized in literature as a biological regulator, currently the biological effects of shockwaves can be obtained using lower energy than in the past.
While the intensity or delivered energy is considered by some researchers to be a key factor for successful treatment, in current literature reviews, debate continues over the appropriate energy intensity and the total delivered energy that should be applied to the tissue.
Therefore, higher intensity treatments usually require local anesthesia, which is known to reduce the efficacy of the treatment. Furthermore, some animal tests reported that an influx of energy of over 0.60 mJ/mm2 can cause permanent damage on the tendon. On the other hand, low-intensity energy is safer but has the disadvantage of lower treatment effects.
The investigators hypothesize that a very low intensity protocol of ESWT has different effects on pain and function than a conventional protocol in a patient with GTPS syndrome.
- Conditions
- Mobility Limitation, Trochanteric Syndrome, Gluteal Tendinitis, Bursitis Hip, Pain Syndrome
- Being tested
- Duolith SD1, STORZ Medical, Switzerland with F-SW applicator
- Keywords
- Greater Trochanteric Pain Syndrome,, Gluteal, Tendinopathy, ESWT, shockwave
- Medical subject headings
- Mobility Limitation, Somatoform Disorders, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duolith SD1, STORZ Medical, Switzerland with F-SW applicatorDevice
Also called Focused Extracorporeal Shock Waves, ESWT
The procedure will be performed with the patient in lateral positioning of the decubitus. The treatment area will be prepared with a coupling ultrasound gel to minimize the loss of shockwave energy at the interface between the tip of the applicator and the skin. The inline ultrasonic guide will be used to concentrate the shockwaves on the pain area in the trochanteric region. No local anesthesia will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 3 weekly sessions of focused extracorporeal shockwave treatment (2.000 impulses at 0.20 millijoules/mm2 per session) Receives: Device: Duolith SD1, STORZ Medical, Switzerland with F-SW applicator |
| Group B | Active comparator | 3 weekly sessions of focused extracorporeal shockwave treatment (2.000 impulses at 0.01 millijoules/mm2 per session) Receives: Device: Duolith SD1, STORZ Medical, Switzerland with F-SW applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) for the estimation of the intensity of pain
The VAS provides a continuous scale for magnitude estimation and consists of a straight line, the ends of which are defined in terms of the extreme limits of pain experience such as 'no pain at all' and 'pain as bad as it could be'. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain experienced. This gives the greatest freedom to choose pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.
Measured: 8 weeks after treatment (T2)
Secondary outcomes (5)
Harris Hip Score (HHS) to evaluate hip disability
The index consists of questions about pain and activities of daily living, referring to the previous week, and assessments of hip function (limping) and range of motion. Score ranges from 100 (no disability) to 0 (maximum disability).
Measured: 4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.
Lower Extremity Functional Scale (LEFS)
The LEFS is a self-report questionnaire to measure "patients' initial function, ongoing progress, and outcome about Lower Extremity. Patients will answer the question "Today, do you or would you have any difficulty at all with:" in regards to twenty different everyday activities. The maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.
Measured: 4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.
Roles and Maudsley scale (RM) to evaluate patients satisfaction
The RM scale is a subjective 4-point patient assessment of pain and limitations of activity. The RM score has been used extensively at centers throughout the world to assess outcome after SWT. On the scale, 1 point indicates an excellent result with the patient having no symptoms. Two points indicate a good result with the patient significantly improved from the pretreatment condition and satisfied with the result. Three points indicate a fair result with the patient somewhat improved from the pretreatment condition and partially satisfied with the treatment outcome. Four points indicate a poor outcome with symptoms identical or worse than the pretreatment condition and dissatisfaction with the treatment result.
Measured: 4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.
EuroQoL five dimensions questionnaire (EQ-5D) to evaluate quality of life
The EQ-5D consists of two distinct sections.The first one is a subjective assessment for five dimensions (mobility, self-care, daily activities, pain / discomfort and anxiety / depression) and each item provides the option to choose a level of gravity. Each item provides graduated answers from 1 to 3. The Level 1 is no problem, while leveling 3 the extreme limitation. The aggregation of the responses forms a five-digit number that represents the state of health. The three levels of response, for each of the five items, produce up to 243 possible descriptions of the state of health and allow to highlight the presence / absence of any problems and the their intensity.
The second section of the EQ-5D includes a VAS scale, represented graphically from a graduated scale ranging from 0 (worst possible health) at 100 (the best possible state of health) on which the interview indicates his perceived level of health status.
Measured: 4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.
Visual Analogue Scale (VAS) for the estimation of the intensity of pain
The VAS provides a continuous scale for magnitude estimation and consists of a straight line, the ends of which are defined in terms of the extreme limits of pain experience such as 'no pain at all' and 'pain as bad as it could be'. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain experienced. This gives the greatest freedom to choose pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.
Measured: 4 (T1), 12 (T3) and 24 (T4) weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Jun 2018
- Primary completion21 Jan 2019
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Chiara Vulpiani, University of Roma La Sapienza
- Investigators
- Maria Chiara Vulpiani, MD, PHD, Principal investigator, Università Sapienza Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338465
- Sponsor's protocol ID
- 4
- Acronym
- ESTATE
- Status last verified
- May 2020
- First submitted
- 2 Nov 2017
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shockwave Treatment in the Greater Trochanteric Pain Syndrome. Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03338465
- Acronym / sponsor ID
- ESTATE / 4
- Conditions
- Mobility Limitation, Trochanteric Syndrome, Gluteal Tendinitis, Bursitis Hip, Pain Syndrome
- Keywords
- Greater Trochanteric Pain Syndrome,, Gluteal, Tendinopathy, ESWT, shockwave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 9 Nov 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.
Greater trochanteric pain syndrome (GTPS) is characterized by pain over the greater trochanter, which can refer down the lateral aspect of the hip. Historically, conservative treatments such as rest/activity modification, anti-inflammatory medication, physiotherapy and local corticosteroid injection, are employed as first-line management, with some refractory cases requiring surgical intervention.
Acknowledging the unpredictable response and frequent recurrences associated with traditional non operative treatment, the risks and prolonged rehabilitation associated with surgery, and the favorable results from prior studies involving radial pressure waves as a treatment for GTPS, the aim of this study is to investigate the dose-related effect of focalized shockwave treatment at different total energy influx in patients with chronic GTPS.
Detailed description
Shockwave therapy (SWT) has been used successfully since the late 1980s for the management of various musculoskeletal disorders including plantar fasciopathy, achilles tendinopathy, shoulder calcific tendinopathy, and lateral epicondylitis. Although there are some negative trials, there are now many randomized, double-blinded, clinical trials that support the use of SWT for the above conditions. Acknowledging the unpredictable response and frequent recurrences associated with traditional non operative treatment, the risks and prolonged rehabilitation associated with surgery, the recognition of gluteal tendinopathy as a potential source of pain, and the favorable results from prior studies involving radial pressure waves as a treatment for GTPS, the aim of this study is to investigate the dose-related effect of shockwave treatment at different total energy by adjusting the energy flux density (EFD) in patients with chronic GTPS. The shockwave has been widely recognized in literature as a biological regulator, currently the biological effects of shockwaves can be obtained using lower energy than in the past.
While the intensity or delivered energy is considered by some researchers to be a key factor for successful treatment, in current literature reviews, debate continues over the appropriate energy intensity and the total delivered energy that should be applied to the tissue.
Therefore, higher intensity treatments usually require local anesthesia, which is known to reduce the efficacy of the treatment. Furthermore, some animal tests reported that an influx of energy of over 0.60 mJ/mm2 can cause permanent damage on the tendon. On the other hand, low-intensity energy is safer but has the disadvantage of lower treatment effects.
The investigators hypothesize that a very low intensity protocol of ESWT has different effects on pain and function than a conventional protocol in a patient with GTPS syndrome.
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 |
|---|---|---|
| Group A | Active comparator | Device: Duolith SD1, STORZ Medical, Switzerland with F-SW applicator3 weekly sessions of focused extracorporeal shockwave treatment (2.000 impulses at 0.20 millijoules/mm2 per session) |
| Group B | Active comparator | Device: Duolith SD1, STORZ Medical, Switzerland with F-SW applicator3 weekly sessions of focused extracorporeal shockwave treatment (2.000 impulses at 0.01 millijoules/mm2 per session) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of either sex, aged oved 18 years, complaining of pain located anterior, lateral or posterior to the great trochanter for more than 3 months.
- Pain while lying on the affected side.
- Local tenderness on palpation of the area of the great trochanter of patients with this symptom as the reason for the consultation.
Key exclusion criteria (8 listed)
- Presence of signs and symptoms of another cause of regional hip pain.
- Presence of hip internal rotation 20° and extension deficit or other range of motion limitation 10º
- Previous hip surgery or use of ESWT for GTPS.
- Acute low back pain
- Vascular, neurologic, rheumatic diseases.
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 |
|---|---|---|
| Duolith SD1, STORZ Medical, Switzerland with F-SW applicatorAlso: Focused Extracorporeal Shock Waves, ESWTThe procedure will be performed with the patient in lateral positioning of the decubitus. The treatment area will be prepared with a coupling ultrasound gel to minimize the loss of shockwave energy at the interface between the tip of the applicator and the skin. The inline ultrasonic guide will be used to concentrate the shockwaves on the pain area in the trochanteric region. No local anesthesia will be applied. | Device | Group A, Group B |
Primary outcome
Visual Analogue Scale (VAS) for the estimation of the intensity of pain
Time frame: 8 weeks after treatment (T2)
The VAS provides a continuous scale for magnitude estimation and consists of a straight line, the ends of which are defined in terms of the extreme limits of pain experience such as 'no pain at all' and 'pain as bad as it could be'. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain experienced. This gives the greatest freedom to choose pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.
5 secondary outcomes
Harris Hip Score (HHS) to evaluate hip disability
Time frame: 4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.
Lower Extremity Functional Scale (LEFS)
Time frame: 4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.
Roles and Maudsley scale (RM) to evaluate patients satisfaction
Time frame: 4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.
EuroQoL five dimensions questionnaire (EQ-5D) to evaluate quality of life
Time frame: 4 (T1), 8 (T2), 12 (T3) and 24 (T4) weeks after treatment.
Visual Analogue Scale (VAS) for the estimation of the intensity of pain
Time frame: 4 (T1), 12 (T3) and 24 (T4) weeks after treatment.
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 1 Jun 2020.
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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.
Maria Chiara Vulpiani, MD, PHD principal investigator
Università Sapienza Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duolith SD1, STORZ Medical, Switzerland with F-SW applicator in people with Mobility Limitation and Trochanteric Syndrome, run by University of Roma La Sapienza 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 3 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 1 Jun 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 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?
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) for the estimation of the intensity of pain (time frame: 8 weeks after treatment (T2)). 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 1 Jun 2020.