The HIP Self-management Study — HIPS  

Trochanteric Bursitis Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06297148
• Study type: Interventional
• Source: Oslo University Hospital
• Contact: Marianne Bakke Johnsen, PhD
• Phone: +47 92439663
• Email: m.b.johnsen@medisin.uio.no
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Completion date: January 1, 2027