Feasibility of Home Exercises With the Addition of a Corticosteroid Injection in Patients With Lateral Hip Pain in General Practice

NCT05086926 | Unknown

• 1 other identifier: Study3-2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lateral Hip Pain; Gluteal Tendinopathy; Greater Trochanteric Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• Acceptability of performing our exercise program

  7-point Likert scale range "very unacceptable" to "very acceptable"

  8 weeks

• Acceptability of performing exercises after receiving a corticosteroid injection

  7-point Likert scale range "very unacceptable" to "very acceptable"

  8 weeks

Secondary Outcomes (5)

• Global Rating of Change

  4 and 8 weeks

• Patent Acceptable Symptom State

  4 and 8 weeks

• Pain Self-Efficacy Questionnaire

  4 and 8 weeks

• Health-related quality of life

  4 and 8 weeks

• Compliance to exercises

  8 weeks

Other Outcomes (1)

• Qualitative outcomes

  4 weeks

Study Arms (1)

Exercises and CSI

EXPERIMENTAL

A corticosteroid injection in the lateral hip prior to performing an 8-week home exercise program

Combination Product: Exercises and CSI

Interventions

Exercises and CSI COMBINATION_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.

Exercises and CSI

Eligibility Criteria

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

You may qualify if:

• \>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)

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 at Aalborg University

Aalborg, 9220, Denmark

RECRUITING

MeSH Terms

Interventions

Exercise; Craniospinal Irradiation

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Radiotherapy; Therapeutics

Central Study Contacts

Sabina Vistrup, MD

CONTACT

40125067; sabinavistrup@dcm.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 21, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)