Clinical trial NCT06297148: The HIP Self-management Study
Official title: Self-management Program for Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GTPS - Greater Trochanteric Pain Syndrome
Gluteal Tendinopathy
Trochanteric Bursitis
Lateral Hip Pain
Keywords: Greater Trochanteric Pain Syndrome
Lateral hip pain
Gluteal tendinopathy
Trochanteric bursitis
Self-management
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
name: Fysiofondet
name: University of Oslo
First posted: 2024-03-07
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Participants between 18 and 70 years of age
* History of lateral hip pain \> 3 months
* Reported average pain intensity the last week ≥ 3 on a numeric rating scale
* Lateral hip pain is the main complaint
* Pain on 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 the presence of bilateral pain will be documented.

Exclusion Criteria:

* Significant back pain causing referred pain to the lateral hip
* Clinical signs of radiculopathy
* Symptomatic osteoarthritis
* Other hip joint pathologies
* History of trauma or surgery on the affected side
* Pregnancy or post-partum pelvic pain (under 12 months since birth)
* Active cancer
* Not able to write, read, and comprehend Norwegian (without the use of an interpreter)

Primary outcomes:
measure: Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G)
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Painful sites
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: The Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: EuroQoL-5 dimensions-5 Level (Eq-5D-5L)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Hopkins Symptoms checklist-10 (HSCL-10)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: iMTA Medical Consumption Questionnaire (iMCQ)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: iMTA Productivity Cost Questionnaire (iPCQ)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Expectations related to VISA-G
timeFrame: Baseline
measure: Expectations on numeric rating scale (NRS)
timeFrame: Baseline, 3 months, 6 months
measure: Global rating of change (GROC)
timeFrame: 6 months
measure: Patient acceptable symptom state (PASS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
Study officials:
References: