Lateral Hip PainNCT05086926
Feasibility of Home Exercises With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain in General Practice
A study testing Exercises and CSI in people with Lateral Hip Pain and Gluteal Tendinopathy, run by Aalborg University at 1 site in Denmark.
Trial summary
Pain on the lateral side of the hip is a common condition in general practice, however there is limited evidence on how to best manage the condition. The purpose of this study is to evaluate the feasibility of a combined treatment before comparing this treatment in a larger clinical trial. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Lateral Hip Pain, Gluteal Tendinopathy, Greater Trochanteric Pain Syndrome
- What is being tested?
- Exercises and CSI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2021to Feb 2022
- 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.
Denmark1 site, 1 recruiting
- Recruiting
Center for General Practice at Aalborg University
Aalborg, 9220
Sabina Vistrup, 40125067, sabinavistrup@dcm.aau.dk
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
Pain on the lateral side of the hip is a common condition in general practice, however there is limited evidence on how to best manage the condition. The purpose of this study is to evaluate the feasibility of a combined treatment before comparing this treatment in a larger clinical trial. For the present study 20 patients with lateral hip pain will be invited to receive a corticosteroid injection in the lateral hip prior to performing our exercise program for 8 weeks. After 4 weeks we will do a short interview to get feedback on the exercise program. After 8 weeks we will evaluate the acceptability of the combined treament.
Read the detailed description
BACKGROUND:
Lateral hip pain or greater trochanteric pain syndrome (GTPS) is pain on the outside of the hip due to tendon pathology of the hip abductor tendons. The incidence in primary care has been reported to be 1.6-3.3 per 1000 patients per year. At present, there is no evidence-based guidelines for the treatment of GTPS in primary care. The investigators of the present study have developed an exercise protocol that is planned be evaluated in a future randomized controlled trial in combination with a corticosteroid injection.
OBJECTIVE:
The purpose of this study is to evaluate feasibility of a home exercise program with the addition of a corticosteroid injection in patients with GTPS in general practice. The primary aim is to evaluate patient acceptability of 1) performing our exercise program 2) performing exercises after receiving a corticosteroid injection. The secondary aim is to obtain feedback from patients through qualitative interviews to be able to refine the exercise intervention after the study is completed. If the combined treatment is found feasible, it is planned to evaluate the effect in a large randomized controlled trial in the future.
STUDY DESIGN:
The study design is a mixed methods feasibility study. The participants are patients with GTPS that will receive a combined treatment of one corticosteroid injection in the lateral hip and a home exercise program, which is to be performed for a period of eight weeks. The acceptability of the combined intervention will be evaluated after 8 weeks.
RECRUITMENT OF PARTICIPANTS:
Patients with GTPS will be recruited from general practice and a private rheumatology practice. Patients will be considered for inclusion if they present to their practitioner with self-reported lateral hip pain. The project manager will make a screening of eligibility by telephone. Those not excluded based on this screening, will be invited to a clinical examination where final eligibility is determined.
ENDPOINTS:
Baseline is at the clinical examination. One week from baseline there will be a short phone contact to the participants in order to clarify any questions related to the exercise program. No data will be obtained at this point. At 4 weeks there will be a phone interview which also serves as a booster session where the participants are encouraged to maintain their exercise routine. At 8 weeks there will be a physical visit where the participants will hand in their exercise diaries and complete the final questionnaires.
CRITERIA OF FEASIBILITY:
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.
In case the combined treatments do not prove feasible according to this set of criteria, it is planned to refine the intervention based on feedback from the interviews and evaluate with a small group of patients for a shorter period of time.
- Being tested
- Exercises and CSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises and CSICombination product
Corticosteroid injection:
The project manager will give the participants one injection with cortisone and lidocaine in the lateral hip at baseline. The procedure will be performed aseptically.
Home exercise program:
The exercise programis 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 8 weeks. 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.
| Study group | Role | What they receive |
|---|---|---|
| Exercises and CSI | Experimental | A corticosteroid injection in the lateral hip prior to performing an 8-week home exercise program Receives: Combination Product: Exercises and CSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of performing our exercise program
7-point Likert scale range "very unacceptable" to "very acceptable"
Measured: 8 weeks
Acceptability of performing exercises after receiving a corticosteroid injection
7-point Likert scale range "very unacceptable" to "very acceptable"
Measured: 8 weeks
Secondary outcomes (5)
Global Rating of Change
This 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: 4 and 8 weeks
Patent Acceptable Symptom State
This 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?"
Measured: 4 and 8 weeks
Pain Self-Efficacy Questionnaire
This is a self-reported measure used to assess how confident patients are in performing activities while in pain. The outcome is a score of 0 to 60, with higher score indicating higher self-efficacy. We will use a Danish validated version
Measured: 4 and 8 weeks
Health-related quality of life
We will use EuroQol-5D-5L. This is a standardized instrument to assess health related quality of life.
Measured: 4 and 8 weeks
Compliance to exercises
Participants will record their exercise sessions using an exercise diary
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Hip PainStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabina Vistrup, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086926
- Sponsor's protocol ID
- Study3-2021
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 21 Oct 2021
- 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 21 Oct 2021. 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
- NCT05086926
- Acronym / sponsor ID
- Study3-2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 21 Oct 2021 (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.
Pain on the lateral side of the hip is a common condition in general practice, however there is limited evidence on how to best manage the condition. The purpose of this study is to evaluate the feasibility of a combined treatment before comparing this treatment in a larger clinical trial. For the present study 20 patients with lateral hip pain will be invited to receive a corticosteroid injection in the lateral hip prior to performing our exercise program for 8 weeks. After 4 weeks we will do a short interview to get feedback on the exercise program. After 8 weeks we will evaluate the acceptability of the combined treament.
Detailed description
BACKGROUND:
Lateral hip pain or greater trochanteric pain syndrome (GTPS) is pain on the outside of the hip due to tendon pathology of the hip abductor tendons. The incidence in primary care has been reported to be 1.6-3.3 per 1000 patients per year. At present, there is no evidence-based guidelines for the treatment of GTPS in primary care. The investigators of the present study have developed an exercise protocol that is planned be evaluated in a future randomized controlled trial in combination with a corticosteroid injection.
OBJECTIVE:
The purpose of this study is to evaluate feasibility of a home exercise program with the addition of a corticosteroid injection in patients with GTPS in general practice. The primary aim is to evaluate patient acceptability of 1) performing our exercise program 2) performing exercises after receiving a corticosteroid injection. The secondary aim is to obtain feedback from patients through qualitative interviews to be able to refine the exercise intervention after the study is completed. If the combined treatment is found feasible, it is planned to evaluate the effect in a large randomized controlled trial in the future.
STUDY DESIGN:
The study design is a mixed methods feasibility study. The participants are patients with GTPS that will receive a combined treatment of one corticosteroid injection in the lateral hip and a home exercise program, which is to be performed for a period of eight weeks. The acceptability of the combined intervention will be evaluated after 8 weeks.
RECRUITMENT OF PARTICIPANTS:
Patients with GTPS will be recruited from general practice and a private rheumatology practice. Patients will be considered for inclusion if they present to their practitioner with self-reported lateral hip pain. The project manager will make a screening of eligibility by telephone. Those not excluded based on this screening, will be invited to a clinical examination where final eligibility is determined.
ENDPOINTS:
Baseline is at the clinical examination. One week from baseline there will be a short phone contact to the participants in order to clarify any questions related to the exercise program. No data will be obtained at this point. At 4 weeks there will be a phone interview which also serves as a booster session where the participants are encouraged to maintain their exercise routine. At 8 weeks there will be a physical visit where the participants will hand in their exercise diaries and complete the final questionnaires.
CRITERIA OF FEASIBILITY:
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.
In case the combined treatments do not prove feasible according to this set of criteria, it is planned to refine the intervention based on feedback from the interviews and evaluate with a small group of patients for a shorter period of time.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercises and CSI | Experimental | Combination Product: Exercises and CSIA corticosteroid injection in the lateral hip prior to performing an 8-week home exercise program |
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 |
|---|---|---|
| Exercises and CSICorticosteroid injection: The project manager will give the participants one injection with cortisone and lidocaine in the lateral hip at baseline. The procedure will be performed aseptically. Home exercise program: The exercise programis 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 8 weeks. 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. | Combination product | Exercises and CSI |
Primary outcome
Acceptability of performing our exercise program
Time frame: 8 weeks
7-point Likert scale range "very unacceptable" to "very acceptable"
Acceptability of performing exercises after receiving a corticosteroid injection
Time frame: 8 weeks
7-point Likert scale range "very unacceptable" to "very acceptable"
5 secondary outcomes
Global Rating of Change
Time frame: 4 and 8 weeks
Patent Acceptable Symptom State
Time frame: 4 and 8 weeks
Pain Self-Efficacy Questionnaire
Time frame: 4 and 8 weeks
Health-related quality of life
Time frame: 4 and 8 weeks
Compliance to exercises
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises and CSI in people with Lateral Hip Pain and Gluteal Tendinopathy, 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: status not confirmed, as of the sponsor's last update on 21 Oct 2021. 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 Sabina Vistrup, MD (40125067, sabinavistrup@dcm.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of performing our exercise program (time frame: 8 weeks). 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 21 Oct 2021.