The HIP Self-management Study

Trochanteric Bursitis Clinical Trial

— HIPS  

Official title:

Self-management Program for Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297148
• Other study ID #: 2023/590816
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: Oslo University Hospital
• Contact: Marianne Bakke Johnsen, PhD
• Phone: +47 92439663
• Email: m.b.johnsen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT). The main purpose of the study is: 1. To investigate the clinical effectiveness of a self- management program versus usual care for patients with greater trochanteric pain syndrome (GTPS). - H0: There is no difference between a self-management program and usual care on pain and function in patients with GTPS. - H1: There is a difference between a self-management program and usual care on pain and function in patients with GTPS. 2. To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS. Participants will be randomly allocated into one of two groups: 1) self-management program or 2) usual care. Follow-up will be at 3-, 6- and 12-months.

Description:

Background: Continuous or intermittent lateral hip pain, also known as greater trochanteric pain syndrome (GTPS), is a common chronic and disabling musculoskeletal condition. It usually occurs during the fourth to sixth decades of life, predominantly among women. The prevalence and incidence rates have been reported to be 4.2 and 3.3 per 1000 person-years, respectively, in the general practice population. The impact of GTPS is reported to be debilitation, as it typically disturbs sleep and limits daily function and participation in work. Exercise and education are considered the cornerstone of treatment, and in recent randomized controlled trials this combination has demonstrated significant improvements in pain and function. However, studies have failed to show any difference between specific hip exercises and non-specific (sham) exercises in combination with patient education. As GTPS is recurrent and persistent of nature, person-centered care and the incorporation of self-management strategies could be beneficial. To the investigators knowledge, this study will be the first one to investigate self-management for the current patient population. Results from the study may change the type, delivery, and content of treatment for patients with GTPS, relevant for both primary- and secondary care. The main objective of the study is to evaluate the clinical effectiveness of a self-management program compared to usual care for patients with GTPS. Methods and analyses: 110 patients will be recruited and randomly allocated into one of two groups: 1) self-management or 2) usual care. The randomization sequence will be computer-generated with blocks of various size, unknown to any of the research team. Due to the nature of therapeutic studies, blinding of the participants and the treating physiotherapist is not possible. The investigator assessing the outcome measures will be blinded to group allocation. Descriptive statistics will be collected at baseline, and presented as means with standard deviation (SD) or as medians with inter quartile range (IQR). The primary analysis will be conducted on the intention to treat population and compare the two intervention groups (self-management vs usual care) on mean difference in pain and disability (VISA-G-N score) at baseline, 3 and 6 months. The estimated mean difference between groups at 6 months (main endpoint) will be analyzed using a longitudinal mixed effects model analysis of covariance. Baseline score on VISA-G-N, time, intervention and interaction between time and intervention will be included as covariates. Secondary outcomes assessed at multiple time points (baseline, 3, 6 and 12 months) will be analyzed by the same approach as described for the primary outcome, on both the intention to treat population and the per protocol population. The degree of missingness will be explored using sensitivity analysis with multiple imputation and/or the use of an alternative repeated measures mixed model analysis accordingly, to assess the robustness of data. In addition, multivariable logistic and linear regression analysis will be used to explore predictive factors, such as demographics, expectations, clinical findings, and psychosocial factors for primary and secondary outcomes. Model building will be done in a way that is appropriate for the given sample sizes, by restricting the number of potential predictive factors and considering shrinkage methods to stabilize predictions. Mediation analysis will be performed to explore the causal pathway between treatment allocation and the primary outcome of pain and disability by considering, amongst others, pain self-efficacy and emotional distress as potential mediators that may be part of the causal pathway between intervention and outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants between 18 and 70 years of age
• History of lateral hip pain > 3 months
• Pain = 3 on a numeric rating scale the last 3 months
• Pain at palpation of the greater trochanter region
• In addition, lateral hip pain on at least one of the following tests:
• Single leg stance test: standing 30 seconds on the affected leg
• FADER: passive stretch/compression of gluteus medius/minimus
• FADER-R: static muscle test with resistance to internal hip rotation
• ADD: passive stretch to hip adduction in sidelying
• ADD-R: resisted hip abduction in sidelying
• FABER (Patrick's) test A positive test is defined as a spontaneous reproduction of the participant's lateral hip pain. In participants with bilateral lateral hip pain, the worst hip will be included, and presence of bilateral pain will be documented.

Exclusion Criteria:

• Significant pain from the lumbar spine, causing referred pain to the hip or clinical signs of lumbar radiculopathy
• Moderate or severe hip osteoarthritis (OA)/total hip replacement (Kellgren-Lawrence grade =2, if relevant, confirmed by hip x-rays. If the participants have taken a previous appropriate x-ray within the last 6 months, they will not require a second x-ray)
• History of trauma or surgery on the affected side
• Not able to fill in questionnaires in Norwegian language
• Pregnancy
• Post-partum pelvic pain (<12 months)
• Active cancer

Related Conditions & MeSH terms

• Bursitis
• Gluteal Tendinopathy
• Syndrome
• Tendinopathy
• Trochanteric Bursitis

Intervention

Other:
• Self-management
Patients will have 3-5 sessions with a physiotherapist that include individually tailored education, and address physical, cognitive, and behavioral factors deemed as relevant according to the participant's concerns and challenges. Important aspects in this are: problem-solving, decision-making, resource utilization, therapeutic alliance and taking action (The 5 core skills of self-management). SMART goals and an activity plan between sessions will be used as an exposure to maintain, change, or create health behavior. Participants will have access to study material, including exercise alternatives and a podcast.
• Usual care
Usual care at the department consists of general information about the condition and advice on pain management and exercise. For further treatment, patients are referred to primary care. Participation in the study will not affect how this is conducted.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevål	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Fysiofondet, Oslo Metropolitan University, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G)	Pain and function. Total score ranges from 0-100, with higher scores representing less pain and disability.	Baseline, 3 months, 6 months, 12 months
Secondary	Numeric rating scale (NRS)	Pain intensity (at rest and during activity) during the last week rated on a scale ranging from 0 (no pain) to 10 (worst possible pain).	Baseline, 3 months, 6 months, 12 months
Secondary	Painful sites	The number of painful sites (during the last 14 days) divided into 18 anatomical regions. Number of painful sites are added up to give a total score.	Baseline, 3 months, 6 months, 12 months
Secondary	The Pain Self-Efficacy Questionnaire (PSEQ)	Confidence in performing activities while in pain. Includes 10-items, where patients rate their confidence from 0 points (not at all confident) to 6 points (completely confident). Total scores are calculated by summing the individual items with a range from 0 points (less self-efficacy) to 60 points (more self-efficacy).	Baseline, 3 months, 6 months, 12 months
Secondary	EuroQoL-5 dimensions-5 Level (Eq-5D-5L)	Generic health related quality of life. The first part is based on 5 questions which are answered on a 5-step scale. It gives an index between 0-1, with a higher index representing better quality of life. The second part, EQ-VAS is a vertical line in which the participants mark the point best describing their quality of life. The score ranges from 0-100, where 100 represents best and 0 worst imaginable health states.	Baseline, 3 months, 6 months, 12 months
Secondary	Hopkins Symptoms checklist-10 (HSCL-10)	Psychological distress measured on a scale from 1 (not at all) to 4 (extremely). The mean score is calculated producing a range of scores from 1-4 where higher score corresponds to more psychological distress.	Baseline, 3 months, 6 months, 12 months
Secondary	iMTA Medical Consumption Questionnaire (iMCQ)	Medical consumption and healthcare utilization. Not measured on a scale, but as total costs. This is estimated based on unit costs collected from national pricelists.	Baseline, 3 months, 6 months, 12 months
Secondary	iMTA Productivity Cost Questionnaire (iPCQ)	The costs of productivity loss (absenteeism) are valued in hours, and can be translated by a standard cost price of productivity per hour.	Baseline, 3 months, 6 months, 12 months
Secondary	Expectations related to VISA-G	Expected change in pain and function (from baseline to 6 months) related to VISA-G. Total score ranges from 0-100, with higher scores representing less pain and disability.	Baseline
Secondary	Expectations on numeric rating scale (NRS)	Expected change in function and pain rated on a scale from 0 (no pain/full function) to10 (worst possible pain/function)	Baseline, 3 months, 6 months
Secondary	Global rating of change (GROC)	Perceived change in lateral hip pain from baseline to follow-up at 6 months, measured on an 11-point likert scale ranging from -5 (much worse) to 5 (completely recovered)	6 months

External Links

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•   Stephens G, O'Neill S, French HP, et al. A survey of physiotherapy practice (2018) in the United Kingdom for patients with greater trochanteric pain syndrome. Musculoskelet Sci Pract 2019;40:10-20. (In eng). DOI: 10.1016/j.msksp.2019.01.004.
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