Feasibility of a Home Exercise Program With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain

NCT06456099 | Recruiting

• 1 other identifier: N-20210011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Greater Trochanteric Pain Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  8-week follow-up

Secondary Outcomes (6)

• Exercise motivation

  Baseline

• Global rating of change (GROC)

  8-week follow-up

• Patient Acceptable Symptom State (PASS)

  8-weeks follow-up

• VISA-G

  Baseline, 4-weeks and 8-weeks follow-up

• Pain Self-Efficacy Questionnaire (PSEQ)

  Baseline, 4-weeks and 8-weeks follow-up

Other Outcomes (1)

• Qualitative outcomes

  4-week and 8-week follow-up

Study Arms (1)

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

Drug: Ultrasound-guided corticosteroid injection; Behavioral: Home exercise program; Behavioral: Patient information leaflet

Interventions

Ultrasound-guided corticosteroid injection DRUG

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.

Also known as: corticosteroid

Home Exercise Program With the Addition of a Corticosteroid Injection

Home exercise program BEHAVIORAL

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").

Home Exercise Program With the Addition of a Corticosteroid Injection

Patient information leaflet BEHAVIORAL

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.

Home Exercise Program With the Addition of a Corticosteroid Injection

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Center For General Practice in Aalborg

Gistrup, 9260, Denmark

RECRUITING

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Malene K Bruun, M.Sc.

  Research Unit for General Practice in Aalborg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens L Olesen, M.Sc.

CONTACT

25144005; jlo@dcm.aau.dk

Malene K Bruun, M.Sc.

CONTACT

24415780; mkbruun@dcm.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: June 7, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)