Exercise and Patient Education for Patients With Lateral Hip Pain

3 Months Semi-supervised Exercise Intervention for Patients With Hip Abductor Tendon Pathology (HATP): A Prospective Clinical Cohort Study

This prospective cohort trial will investigate a progressive exercise protocol and patient education for patients with hip abductor tendon pathology. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), that will be conducted at baseline and at a 12 week follow-up.

Study Overview

• Status: Recruiting
• Conditions: Greater Trochanteric Pain Syndrome; Gluteal Tendinitis; Rupture of Hip Abductor Tendon (Disorder); Hip and Thigh Injury
• Intervention / Treatment: Procedure: Exercise and Patient Education

Detailed Description

This study protocol describes an interventional pragmatic prospective single-group cohort study, where the primary endpoint is change in hip pain measured with the revised HAGOS pain subscale following a 12 week intervention. Throughout the 12 weeks, eight physiotherapist-led exercise sessions will take place at Horsens Regional Hospital (HRH). Further, at the sessions at HRH patient education will be performed by the supervising physiotherapist. The first supervised sessions will be performed in continuation of the baseline assessment. The patients will be instructed to do the exercises daily at home in the time period between the physiotherapist-led sessions.

The primary aim is to investigate changes in patient-reported hip pain based on the subscale "pain" from the revised Copenhagen Hip And Groin Outcome Score (HAGOS) from baseline to 12 week follow-up.

It is hypothesized that the revised HAGOS pain score will improve from baseline to 12 week follow-up.

Secondarily explorative subgroup analyses regarding whether patients with different MRI findings, pain profiles, age, sex and body mass index (BMI) respond differently to the intervention, will be performed.

All outcomes conducted will be published. That is, patient-reported outcomes, muscle strength, functional capacity and adherence to the exercise protocol.

A full study protocol will be published and made available.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeppe Lange, MD, PhD; Email: jepplang@rm.dk
• Study Contact Backup: Name: Mathias Høgsholt, PT,PhD.-st.; Phone Number: +45 24205299; Email: mathhg@rm.dk

Study Locations

• Denmark
  • Horsens, Denmark, 8700
    • Recruiting
    • Horsens Regional Hospital
    • Contact: Mathias Høgsholt, PT,PhD.-st.; Phone Number: +45 24205299; Email: mathhg@rm.dk
    • Contact: Jeppe Lange, MD,PhD.; Email: jepplang@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-75 years
• MRI verified HATP
• Lateral hip pain duration > 6 months
• Ability to read and understand Danish.

Exclusion Criteria:

• Corticosteroid injection in the affected hip joint within the last six weeks prior to the intervention
• Previous bone-related surgery to the affected hip,
• Signs of bilateral HATP
• X-ray verified hip osteoarthritis
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiotherapist-led exercise; Physiotherapy-led exercise of patients with lateral hip pain	Procedure: Exercise and Patient Education; Patients will undergo a 12-week physiotherapist-led exercise program consisting of 8 supervised sessions and home-based training in between. Patients will keep training diaries, where each session is tracked in regards of completed repetitions and pain before and after the sessions. Each session will consist of four exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)	The subscale "pain" on HAGOS measures the patients perception of hip and/or groin pain. It consist of ten items. A score from 0 to 100 is calculated, where a higher score is indicating lower pain.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)	The subscale "symptoms" on HAGOS measures the patients perception of hip and/or groin pain. It consist of seven items. A score from 0 to 100 is calculated, where a higher score is indicating lower symptoms.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)	The subscale "ADL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher function.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes in patient-reported physical function in sport and recreational activities (sport/recreation) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)	The subscale "sport/recreation" on HAGOS measures the patients perception of hip and/or groin pain. It consist of eight items. A score from 0 to 100 is calculated, where a higher score is indicating higher function.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)	The subscale "PA" on HAGOS measures the patients perception of hip and/or groin pain. It consist of two items. A score from 0 to 100 is calculated, where a higher score is indicating higher ability to participate in physical activity.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)	The subscale "QOL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher quality of life.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes in the patient-reported outcome measure Oxford Hip Score (continuous data)	Oxford Hip Score (OHS), which consists of 12items. OHS is developed and validated for patients undergoing total hip replacements to access pain and function. It is a composite score ranging from 0 (worst) to 48 (best).	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes in the patient-reported outcome measure EQ-5D-5L (continuous data)	European Questionnaire-5 Dimensions (EQ-5D-5L and EQ-VAS) consists of five items and a visual analogue score (VAS), a vertical line on which the patients score their perception of their overall health from 0 to 100 (worst to best)	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Global Rating of Change (GRoC)	GRoC consists of a 11-point scale, where the patient rates the perceived overall change of the hip condition from "very much better" to "very much worse" . Responses on GRoC will be considered successful if patients scored "moderately better" to "very much better". Global improvement will be measured as the percentage of successful reports.	The outcome is conducted at 6-week and 3-months follow-up.
Lateral hip pain on a numerical pain rating scale (NRS)	Participants rate their pain on a scale from 0 (no pain) to 10 (worst imaginable). Participants will rate their average pain for the past 7 days during rest, at the beginning of activity, during activity, 2 hours after activity and the worst lateral hip pain.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)	The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) is validated for patients with gluteal tendinopathy and measures the severity of disability related to the condition. VISA-G consist of eight items and appraise the pain in relation to gluteal tendinopathy by a score from 0-100, where a higher score will indicate lower pain and less disability.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes of maximal isometric hip abduction muscle strength (continuous data)	Maximal isometric hip abduction strength test measures the maximal voluntary isometric contraction in supine position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes of maximal isometric hip adduction muscle strength (continuous data)	Maximal isometric hip adduction strength test measures the maximal voluntary isometric contraction in supine position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes of maximal isometric hip flexion muscle strength (continuous data)	Maximal isometric hip flexion strength test measures the maximal voluntary isometric contraction in sitting position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes of maximal isometric hip extension muscle strength (continuous data)	Maximal isometric hip extension strength test measures the maximal voluntary isometric contraction in prone position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Changes of the number of repetitions of a 30 second sit to stand test (continuous data)	Number of repetitions (sits to stand) performed during 30 seconds on a chair with a seat height of 45 cm.	From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the exercise program.	The adherence will be calculated as the proportion of completed exercise sessions in relation to the planned exercise sessions. A high adherence will be defined as completion of 75% or more of the planned exercises sessions (both supervised and home-based), medium adherence with completion of 50-74%, and low adherence with completion of less than 50%.	From baseline to 3 months follow-up.

Collaborators and Investigators

• Sponsor: Jeppe Lange
• Collaborators: University of Aarhus
• Investigators: Study Chair: Kristian Thorborg, PhD, Copenhagen University Hospital, Hvidovre; Principal Investigator: Mathias Høgsholt, PT, PhD.st., Horsens Regional Hospital; Aarhus University; Study Director: Jeppe Lange, MD, PhD, Horsens Regional Hospital; Aarhus University; Study Chair: Signe Kierkegaard-Brøchner, PhD, Regionshospitalet Horsens; Study Chair: Marie Bagger Bohn, MD, PhD, Regionshospitalet Horsens

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Patient education; Lateral Hip Pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Rupture; Tendinopathy
• Other Study ID Numbers: 1-16-02-180-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

What data will be shared: All quantitative individual participant data collected during the trial, after deidentification, and according to current Danish Data Protection Regulation and GDPR.

With whom will data be shared: Researchers who provide a methodologically sound proposal.

For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trial: A Requirement of the ICMJE located at: https://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf

• IPD Sharing Time Frame: Immediately following publication and ending 5 years following primary article publication.
• IPD Sharing Access Criteria: Proposals should be directed to mathhg@rm.dk. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No