Gluteal Tendinitis, Greater Trochanteric Pain Syndrome, Hip and Thigh Injury, Rupture of Hip Abductor Tendon (Disorder)
Conditions
Keywords
Exercise, Patient education, Lateral Hip Pain, Rehabilitation
Brief summary
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.
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.
Interventions
PROCEDUREExercise 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.
Sponsors
University of Aarhus
Jeppe Lange
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lateral hip pain on a numerical pain rating scale (NRS) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| 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) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes in the patient-reported outcome measure Oxford Hip Score (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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). |
| Global Rating of Change (GRoC) | The outcome is conducted at 6-week and 3-months follow-up. | 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. |
| Changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes of maximal isometric hip abduction muscle strength (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes of maximal isometric hip adduction muscle strength (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes of maximal isometric hip flexion muscle strength (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes of maximal isometric hip extension muscle strength (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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. |
| Changes of the number of repetitions of a 30 second sit to stand test (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | Number of repetitions (sits to stand) performed during 30 seconds on a chair with a seat height of 45 cm. |
| Changes in the patient-reported outcome measure EQ-5D-5L (continuous data) | From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up. | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the exercise program. | From baseline to 3 months follow-up. | 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%. |
Countries
Denmark
Contacts
Primary ContactMathias Høgsholt, PT,PhD.-st.
Backup ContactJeppe Lange, MD, PhD
Outcome results
None listed