TendinopathyNCT04058509
Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain
A study testing Focused shockwave therapy in people with Tendinopathy, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This pragmatic clinical trial is considering the variable response to treatment outcome of individuals with Greater Trochanteric Pain Syndrome (GTPS). The aim of this study is to identify predictors of focused extracorporeal shockwave therapy (fESWT) efficacy in individuals with GTPS. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Focused shockwave therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Nov 2018to 30 Jul 2020
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lateral hip pain, worst over the greater trochanter, present for a minimum of 3 months
- Age 35-70 years
- Female
- Pain at an average intensity of ≥3 out of 10 on most days of the last week.
- Tenderness on palpation of the greater trochanter
- Pain on one of the following:
- Reproduction of pain on 30 sec single leg stand OR Positive Faber test
Who cannot join
- Any known advanced hip joint pathology where groin pain is the primary complaint and/or reproduction of groin pain with Faber or FADDIR.
- Where range of pure hip joint flexion is <90°
- Radiating pain distal to the Gluteus Max + positive Straight Leg Raise (SLR-test < 30°)
- Known advanced knee pathology or restricted range of knee motion (must have minimum 90° flexion and full extension)
- Any systemic diseases affecting the muscular or nervous system, and uncontrolled diabetes
- Malignant tumour OR Systemic inflammatory disease
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- Any factors that would preclude the participant from having an MRI (e.g. pacemaker, metal implants, pregnancy, claustrophobia)
- If the participant is involved in a legal/workcover or other injury claim
- Fear of needles (trypanophobia)
- If the participant is unable to write, read or comprehend Danish
Trial locations and contacts
1 site in 1 country.
Jens Kristinsson, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Carsten M Molgaard, PhD, cmm@rn.dk
Jens Kristinsson, MD, hjk@rn.dk
About this study
This pragmatic clinical trial is considering the variable response to treatment outcome of individuals with Greater Trochanteric Pain Syndrome (GTPS). The aim of this study is to identify predictors of focused extracorporeal shockwave therapy (fESWT) efficacy in individuals with GTPS. Specifically, the ability of clinically applicable measurements including: Patient demographics, co-morbidity, oestrogen levels, pain characteristics, hip abductor strength, time to pain during single-leg stance test, low back pain, and immediate pain reduction to local anaesthetic injection at the trochanter major insertion of Gluteus medius (GMed) during walking.
- Conditions
- Tendinopathy
- Being tested
- Focused shockwave therapy
- Keywords
- Greater Trochanter Pain Syndrome, Lateral hip pain
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused shockwave therapyCombination product
3 session of shockwave therapy. The wave is focused through a standoff and transmitted into the tissue. Enhanced Energy: 0.01 - 0.55mJ/mm2. Broad Frequency Range: 1 - 8Hz. 12.5 cm penetration with pinpoint focus. The patient will be treated in the lateral decubitus position. The shock wave will focus on the area of maximal tenderness, which will be treated in a circumferential pattern.
| Study group | Role | What they receive |
|---|---|---|
| focused shockwave therapy | Experimental | 3 sessions of shock wave treatment.(Focused Shockwave Therapy). Receives: Combination Product: Focused shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Rating of Change Scale
Measured: 3 months follow-up
Secondary outcomes (6)
EuroQoL
EQ-5D™
Measured: 0, 12 and 26 weeks follow-up
Muscle strength Static
Hip abduction strength
Measured: 0, 12 and 26 weeks follow-up
Pain Pressure Threshold
Lateral hip region
Measured: 0, 12 and 26 weeks follow-up
Patient-Specific Functional Scale).
difficulties with 1-5 functional tasks
Measured: 0, 6, 12 and 26 weeks follow-up
PHQ9
Severity of depression
Measured: 0, 12 and 26 weeks follow-up
VISA-G
disability score for gluteal tendinopathy
Measured: 0, 12 and 26 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start28 Nov 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
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 Aalborg University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Canberra
- Responsible party
- Principal investigator, Carsten Møller Poulsen Mølgaard, Aalborg University Hospital
- Investigators
- Carsten M Molgaard, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058509
- Sponsor's protocol ID
- N-20180036
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 15 Aug 2019
- 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 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain
- ClinicalTrials.gov ID
- NCT04058509
- Acronym / sponsor ID
- N-20180036
- Conditions
- Tendinopathy
- Keywords
- Greater Trochanter Pain Syndrome, Lateral hip pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- University of Canberra
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 15 Aug 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.
This pragmatic clinical trial is considering the variable response to treatment outcome of individuals with Greater Trochanteric Pain Syndrome (GTPS). The aim of this study is to identify predictors of focused extracorporeal shockwave therapy (fESWT) efficacy in individuals with GTPS. Specifically, the ability of clinically applicable measurements including: Patient demographics, co-morbidity, oestrogen levels, pain characteristics, hip abductor strength, time to pain during single-leg stance test, low back pain, and immediate pain reduction to local anaesthetic injection at the trochanter major insertion of Gluteus medius (GMed) during walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| focused shockwave therapy | Experimental | Combination Product: Focused shockwave therapy3 sessions of shock wave treatment.(Focused Shockwave Therapy). |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Lateral hip pain, worst over the greater trochanter, present for a minimum of 3 months
- Age 35-70 years
- Female
- Pain at an average intensity of ≥3 out of 10 on most days of the last week.
- Tenderness on palpation of the greater trochanter
Key exclusion criteria (10 listed)
- Any known advanced hip joint pathology where groin pain is the primary complaint and/or reproduction of groin pain with Faber or FADDIR.
- Where range of pure hip joint flexion is <90°
- Radiating pain distal to the Gluteus Max + positive Straight Leg Raise (SLR-test < 30°)
- Known advanced knee pathology or restricted range of knee motion (must have minimum 90° flexion and full extension)
- Any systemic diseases affecting the muscular or nervous system, and uncontrolled diabetes
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 shockwave therapy3 session of shockwave therapy. The wave is focused through a standoff and transmitted into the tissue. Enhanced Energy: 0.01 - 0.55mJ/mm2. Broad Frequency Range: 1 - 8Hz. 12.5 cm penetration with pinpoint focus. The patient will be treated in the lateral decubitus position. The shock wave will focus on the area of maximal tenderness, which will be treated in a circumferential pattern. | Combination product | focused shockwave therapy |
Primary outcome
Global Rating of Change Scale
Time frame: 3 months follow-up
6 secondary outcomes
EuroQoL
Time frame: 0, 12 and 26 weeks follow-up
Muscle strength Static
Time frame: 0, 12 and 26 weeks follow-up
Pain Pressure Threshold
Time frame: 0, 12 and 26 weeks follow-up
Patient-Specific Functional Scale).
Time frame: 0, 6, 12 and 26 weeks follow-up
PHQ9
Time frame: 0, 12 and 26 weeks follow-up
VISA-G
Time frame: 0, 12 and 26 weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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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.
Jens Kristinsson, MD contact
Carsten M Molgaard, PhD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused shockwave therapy in people with Tendinopathy, run by Aalborg University Hospital at 1 site in Denmark.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Aug 2019. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carsten M Molgaard, PhD (+4523806882, cmm@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Rating of Change Scale (time frame: 3 months follow-up). 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 15 Aug 2019.