Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456099
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain
Sponsor:
Aalborg University
Organization:
Aalborg University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None