Greater Trochanteric Pain SyndromeNCT06456099
Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain
A study testing Ultrasound-guided corticosteroid injection, Home exercise program and Patient information leaflet in people with Greater Trochanteric Pain Syndrome, run by Aalborg University at 1 site in Denmark.
Trial summary
We have developed an exercise protocol that we plan to evaluate in a future randomized controlled trial in combination with a corticosteroid injection. In accordance with the MRC Framework of Complex Interventions, which reccomends stepwise development of interventions and testing of feasibility before applying them… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Greater Trochanteric Pain Syndrome
- What is being tested?
- Ultrasound-guided corticosteroid injection, Home exercise program and Patient information leaflet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jun 2024to 6 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35 years of age
- Self-reported pain on the outside of the hip for at least 12 weeks with an average intensity of present pain over the last week of at least 4/10 on a numeric rating scale 0-10 (0 being no hip pain and 10 being worst hip pain imaginable)
- Access to a computer, smartphone or tablet with internet connection
- Tenderness on palpation of the greater trochanter
- Reproduction of lateral hip pain with 30 sec single leg stance test
- Ability to speak and understand Danish (written and oral)
- In case of bilateral hip pain, the study hip will be the most painful at inclusion
Who cannot join
- Corticosteroid injection in the affected hip or other new treatment by a health professional within the last 3 months
- History of systemic inflammatory diseases, e.g. rheumatoid arthritis, spondyloarthritis
- Weekly intake of oral glucocorticoids
- History of other hip conditions, e.g. clinically significant hip osteoarthritis, hip dysplasia, prior hip surgery
- History of prior lumbar back surgery
- Current low back pain or episodes of low back pain within the last 3 months that have caused sick leave and/or treatment by a health professional
- Physical or mental disabilities that make it impossible to understand and/or perform exercises and complete questionnaires
- Current or planned pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Greater Trochanteric Pain Syndrome in General Practice
We have developed an exercise protocol that we plan to evaluate in a future randomized controlled trial in combination with a corticosteroid injection. In accordance with the MRC Framework of Complex Interventions, which reccomends stepwise development of interventions and testing of feasibility before applying them to a trial, we aim to evaluate the feasibility of our intervention before initiating further trials.
The purpose of this non-randomized feasibility study is to test the feasibility and acceptability of this exercise protocol with addition of a corticosteroid injection with no aim of evaluating effects.
Read more
All participants in this study will receive the following interventions:
- An ultrasound-guided corticosteroid injection superficial to the insertion of the gluteus medius and minimus tendons on the greater trochanter of the hip.
- A home exercise program including 3 exercises, scalable to 3 different difficulty levels.
- A patient information leaflet containing relevant information on managing lateral hip pain.
Read the detailed description
The study design is a mixed methods feasibility study. We will include patients with GTPS that will receive a combined treatment of one ultrasound-guided corticosteroid injection in the lateral hip and a home exercise program, which is to be performed for a period of eight weeks.
For this study we plan to include 20 voluntary patients with GTPS from general practice and a private rheumatology practice. Participants will be recruited from general practice clinics and one private rheumatology practice in the North Denmark Region. Participants will attend physical visits at baseline and at 8-weeks follow-up. There is a booster session four weeks from baseline, that is conducted by phone. The content of each endpoint is stated in the following:
Baseline: Physical visit The baseline visit is managed by the project manager and includes a clinical examination and data collection of baseline characteristics. The participant will complete questionnaires. The patient information leaflet and the exercise instructions with a training diary will be handed out to the participant. The participant will receive an ultrasound-guided corticosteroid injection in the lateral hip. Appointments will be made for phone contact and 8-weeks follow-up.
Phone contact at one week from baseline: The project manager will contact the patients by phone after one week to clarify any questions about training instructions, the training diary or technical issues with accessing the video instructions. No data will be obtained.
4-weeks follow-up: Booster session and phone interview This booster session is conducted by the project manager via phone to encourage the participants to maintain their training routine, and to address any challenges, questions or difficulties in performing the exercises. In addition, we will do a short five-question interview to get feedback on the exercise intervention. The interview will be recorded, and the recordings will be transcribed. In addition to the phone conversation, the participants will receive questionnaires via email that are to be completed online in REDCap.
8-weeks follow-up: Physical visit at ReumaNord or Center for General Practice The participants will meet with the project manager at this final endpoint to hand in the training diary and complete questionnaires and repeat the interview done at the previous follow-up. The location will depend on what is logistically possible, but the appointment will in either case be made with the participant at baseline.
- Conditions
- Greater Trochanteric Pain Syndrome
- Being tested
- Ultrasound-guided corticosteroid injection, Home exercise program, Patient information leaflet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided corticosteroid injectionDrug
Also called corticosteroid
Participants will receive one ultrasound-guided injection with 1 ml Kenalog 40mg/ml and 1 ml Lidocaine 10mg/ml superficial to the insertion of the gluteus medius and minimus tendons on the greater trochanter of the hip at baseline, Prior to the beginning of exercises.
Home exercise programBehavioural
Our exercise protocol is based on previous literature and expert opinions that has been synthesized in a Delphi study conducted by our research group. The exercise program consists of three body weighted strength exercises, that are to be performed every second day for a period of eight weeks (see appendix 6, "Træningsvejledning"). Exercise instructions will be available as a handout and online with video instructions. The corticosteroid injection usually causes a flare-up in pain with a duration of up to 48 hours. Participants will be instructed to begin the exercises as soon as possible after this flare-up has settled. Compliance to exercises are measured using a training diary that the participants must fill out during the study period (see appendix 7, "Træningsdagbog").
Patient information leafletBehavioural
In order to support self-management and modification of tendon load, participants will receive a handout at baseline that contains information about GTPS and advice on load management (see appendix 8, "Folder - Smerter på ydersiden af hoften"). The participants will be encouraged to read the leaflet regularly and follow the advice.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Program With the Addition of a Corticosteroid Injection | Experimental | All participants in this study will receive the following interventions:
* Ultrasound-guided corticosteroid injection
* Home exercise program
* Patient information leaflet Receives: Drug: Ultrasound-guided corticosteroid injection; Behavioral: Home exercise program; Behavioral: Patient information leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of performing our exercise program
This outcomes will be evaluated by asking the participants the following question "How acceptable was it for you to perform the exercise program?". This will be answered using a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". The responses will be dichotomized as either "unacceptable" (category 1-4) or "acceptable" (category 5-7). Participants will be asked to elaborate their responses in a text field. Compliance to exercises will be measured using a training diary.
Measured: 8-week follow-up
Acceptability of performing exercises after receiving a corticosteroid injection
This outcome will be evaluated by asking the participants the question "How acceptable was it for you to start doing exercises shortly after receiving a corticosteroid injection?". This will be answered using a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". The responses will be dichotomized as either "unacceptable" (category 1-4) or "acceptable" (category 5-7). Participants will be asked to elaborate their responses in a text field.
Measured: 8-week follow-up
Feasibility of the Home exercise program with the addition of a corticosteroid injection
To conclude that the combined treatments are feasible, ≥ 75% of patients must rate the treatment as 'acceptable'. If any participant drops out after the injection, they will be dichotomized as "not acceptable". A minimum of 15/20 training diaries must be handed in at 8-weeks follow-up. Based on the returned training diaries, ≥ 75% of participants need to complete ≥ 20/28 possible training sessions. A training session will be considered completed if the participant has performed at least one set of each exercise.
Measured: 8-week follow-up
Secondary outcomes (6)
Exercise motivation
Exercise motivation is assessed using a 5-point Likert scale
Measured: Baseline
Global rating of change (GROC)
GROC is determined by asking the question "How is your lateral hip pain now compared to when you first came in for treatment in this project?", which will be responded to with a 7-point Likert scale ranging from "very much worse" to "very much better".
Measured: 8-week follow-up
Patient Acceptable Symptom State (PASS)
PASS will be identified by asking the patient to answer yes or no to the question "Is your lateral hip pain at an acceptable level that does not require any further treatment?" Average of present lateral hip pain intensity over the last week on a numeric rating scale 0-10
Measured: 8-weeks follow-up
VISA-G
Question 1 receives a VAS rating of 0 to 10. (10 is optimal health) The 5 categories on questions 2 through 6 can be scored as 0, 2, 5, 7, or 10. The 4 categories on question 7 can be scored as 0, 4, 7, or 10. Question 8 is graded according to how long the patient can train in spite of their current level of pain.
The maximum score for an asymptomatic person is 100; the smallest score is 0
Measured: Baseline, 4-weeks and 8-weeks follow-up
Pain Self-Efficacy Questionnaire (PSEQ)
Each item is scored on a 7-point scale ranging from 0 (not at all confident) to 6 (completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy in managing pain and performing daily activities.
Measured: Baseline, 4-weeks and 8-weeks follow-up
Health-related quality of life (EQ-5D-5L)
The EQ-5D-5L is measured by having patients complete a questionnaire that assesses their health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity: no problems, slight problems, moderate problems, severe problems, and extreme problems. Additionally, patients rate their overall health on a visual analog scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Baseline, 4-week and 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start7 Jun 2024
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Trochanteric Pain SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Kjær Bruun, Aalborg University
- Investigators
- Malene K Bruun, M.Sc., Principal investigator, Research Unit for General Practice in Aalborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456099
- Sponsor's protocol ID
- N-20210011
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Greater Trochanteric Pain Syndrome in General Practice
- ClinicalTrials.gov ID
- NCT06456099
- Acronym / sponsor ID
- N-20210011
- Conditions
- Greater Trochanteric Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 13 Jun 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.
We have developed an exercise protocol that we plan to evaluate in a future randomized controlled trial in combination with a corticosteroid injection. In accordance with the MRC Framework of Complex Interventions, which reccomends stepwise development of interventions and testing of feasibility before applying them to a trial, we aim to evaluate the feasibility of our intervention before initiating further trials.
The purpose of this non-randomized feasibility study is to test the feasibility and acceptability of this exercise protocol with addition of a corticosteroid injection with no aim of evaluating effects.
All participants in this study will receive the following interventions:
- An ultrasound-guided corticosteroid injection superficial to the insertion of the gluteus medius and minimus tendons on the greater trochanter of the hip.
- A home exercise program including 3 exercises, scalable to 3 different difficulty levels.
- A patient information leaflet containing relevant information on managing lateral hip pain.
Detailed description
The study design is a mixed methods feasibility study. We will include patients with GTPS that will receive a combined treatment of one ultrasound-guided corticosteroid injection in the lateral hip and a home exercise program, which is to be performed for a period of eight weeks.
For this study we plan to include 20 voluntary patients with GTPS from general practice and a private rheumatology practice. Participants will be recruited from general practice clinics and one private rheumatology practice in the North Denmark Region. Participants will attend physical visits at baseline and at 8-weeks follow-up. There is a booster session four weeks from baseline, that is conducted by phone. The content of each endpoint is stated in the following:
Baseline: Physical visit The baseline visit is managed by the project manager and includes a clinical examination and data collection of baseline characteristics. The participant will complete questionnaires. The patient information leaflet and the exercise instructions with a training diary will be handed out to the participant. The participant will receive an ultrasound-guided corticosteroid injection in the lateral hip. Appointments will be made for phone contact and 8-weeks follow-up.
Phone contact at one week from baseline: The project manager will contact the patients by phone after one week to clarify any questions about training instructions, the training diary or technical issues with accessing the video instructions. No data will be obtained.
4-weeks follow-up: Booster session and phone interview This booster session is conducted by the project manager via phone to encourage the participants to maintain their training routine, and to address any challenges, questions or difficulties in performing the exercises. In addition, we will do a short five-question interview to get feedback on the exercise intervention. The interview will be recorded, and the recordings will be transcribed. In addition to the phone conversation, the participants will receive questionnaires via email that are to be completed online in REDCap.
8-weeks follow-up: Physical visit at ReumaNord or Center for General Practice The participants will meet with the project manager at this final endpoint to hand in the training diary and complete questionnaires and repeat the interview done at the previous follow-up. The location will depend on what is logistically possible, but the appointment will in either case be made with the participant at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Program With the Addition of a Corticosteroid Injection | Experimental | Drug: Ultrasound-guided corticosteroid injection, Behavioral: Home exercise program, Behavioral: Patient information leafletAll participants in this study will receive the following interventions: * Ultrasound-guided corticosteroid injection * Home exercise program * Patient information leaflet |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 35 years of age
- Self-reported pain on the outside of the hip for at least 12 weeks with an average intensity of present pain over the last week of at least 4/10 on a numeric rating scale 0-10 (0 being no hip pain and 10 being worst hip pain imaginable)
- Access to a computer, smartphone or tablet with internet connection
- Tenderness on palpation of the greater trochanter
- Reproduction of lateral hip pain with 30 sec single leg stance test
Key exclusion criteria (8 listed)
- Corticosteroid injection in the affected hip or other new treatment by a health professional within the last 3 months
- History of systemic inflammatory diseases, e.g. rheumatoid arthritis, spondyloarthritis
- Weekly intake of oral glucocorticoids
- History of other hip conditions, e.g. clinically significant hip osteoarthritis, hip dysplasia, prior hip surgery
- History of prior lumbar back surgery
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 |
|---|---|---|
| Ultrasound-guided corticosteroid injectionAlso: corticosteroidParticipants will receive one ultrasound-guided injection with 1 ml Kenalog 40mg/ml and 1 ml Lidocaine 10mg/ml superficial to the insertion of the gluteus medius and minimus tendons on the greater trochanter of the hip at baseline, Prior to the beginning of exercises. | Drug | Home Exercise Program With the Addition of a Corticosteroid Injection |
| Home exercise programOur exercise protocol is based on previous literature and expert opinions that has been synthesized in a Delphi study conducted by our research group. The exercise program consists of three body weighted strength exercises, that are to be performed every second day for a period of eight weeks (see appendix 6, "Træningsvejledning"). Exercise instructions will be available as a handout and online with video instructions. The corticosteroid injection usually causes a flare-up in pain with a duration of up to 48 hours. Participants will be instructed to begin the exercises as soon as possible after this flare-up has settled. Compliance to exercises are measured using a training diary that the participants must fill out during the study period (see appendix 7, "Træningsdagbog"). | Behavioural | Home Exercise Program With the Addition of a Corticosteroid Injection |
| Patient information leafletIn order to support self-management and modification of tendon load, participants will receive a handout at baseline that contains information about GTPS and advice on load management (see appendix 8, "Folder - Smerter på ydersiden af hoften"). The participants will be encouraged to read the leaflet regularly and follow the advice. | Behavioural | Home Exercise Program With the Addition of a Corticosteroid Injection |
Primary outcome
Acceptability of performing our exercise program
Time frame: 8-week follow-up
This outcomes will be evaluated by asking the participants the following question "How acceptable was it for you to perform the exercise program?". This will be answered using a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". The responses will be dichotomized as either "unacceptable" (category 1-4) or "acceptable" (category 5-7). Participants will be asked to elaborate their responses in a text field. Compliance to exercises will be measured using a training diary.
Acceptability of performing exercises after receiving a corticosteroid injection
Time frame: 8-week follow-up
This outcome will be evaluated by asking the participants the question "How acceptable was it for you to start doing exercises shortly after receiving a corticosteroid injection?". This will be answered using a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". The responses will be dichotomized as either "unacceptable" (category 1-4) or "acceptable" (category 5-7). Participants will be asked to elaborate their responses in a text field.
Feasibility of the Home exercise program with the addition of a corticosteroid injection
Time frame: 8-week follow-up
To conclude that the combined treatments are feasible, ≥ 75% of patients must rate the treatment as 'acceptable'. If any participant drops out after the injection, they will be dichotomized as "not acceptable". A minimum of 15/20 training diaries must be handed in at 8-weeks follow-up. Based on the returned training diaries, ≥ 75% of participants need to complete ≥ 20/28 possible training sessions. A training session will be considered completed if the participant has performed at least one set of each exercise.
6 secondary outcomes
Exercise motivation
Time frame: Baseline
Global rating of change (GROC)
Time frame: 8-week follow-up
Patient Acceptable Symptom State (PASS)
Time frame: 8-weeks follow-up
VISA-G
Time frame: Baseline, 4-weeks and 8-weeks follow-up
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline, 4-weeks and 8-weeks follow-up
Health-related quality of life (EQ-5D-5L)
Time frame: Baseline, 4-week and 8-week follow-up
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 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Malene K Bruun, M.Sc. principal investigator
Research Unit for General Practice in Aalborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided corticosteroid injection, Home exercise program and Patient information leaflet in people with Greater Trochanteric Pain Syndrome, run by Aalborg University 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 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 2 Oct 2026. 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?
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?
Acceptability of performing our exercise program (time frame: 8-week follow-up). The study lists 3 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 2 Oct 2026.