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GTPS - Greater Trochanteric Pain SyndromeHIPSNCT06297148

The HIP Self-management Study

A study testing Self-management in people with GTPS - Greater Trochanteric Pain Syndrome and Gluteal Tendinopathy, run by Oslo University Hospital at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Self-management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteNorway
Study dates
12 Mar 2024to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 13Show fewer
  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Oslo University Hospital, Ullevål

    Oslo, 0450

Other trials in Norway

About this study

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

The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT).

The main purpose of the study is:

Read more
  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.
  1. 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.

Read the 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.

Being tested
Self-management, Usual care
Keywords
Greater Trochanteric Pain Syndrome, Lateral hip pain, Gluteal tendinopathy, Trochanteric bursitis, Self-management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-managementOther

    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 careOther

    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.

Study groups in NCT06297148
Study groupRoleWhat they receive
Self-managementExperimentalThe intervention will consist of 3-5 individual sessions over 12 weeks with a physiotherapist. There will be 3 physiotherapists delivering the self-management intervention.
Receives: Other: Self-management
Usual careActive comparatorGiven standardized information at baseline and free to choose further treatment in primary care.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months, 6 months, 12 months

Secondary outcomes (11)
  1. 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).

    Measured: Baseline, 3 months, 6 months, 12 months

  2. 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.

    Measured: Baseline, 3 months, 6 months, 12 months

  3. 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).

    Measured: Baseline, 3 months, 6 months, 12 months

  4. 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.

    Measured: Baseline, 3 months, 6 months, 12 months

  5. 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.

    Measured: Baseline, 3 months, 6 months, 12 months

  6. 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.

    Measured: Baseline, 3 months, 6 months, 12 months

  7. 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.

    Measured: Baseline, 3 months, 6 months, 12 months

  8. 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.

    Measured: Baseline

  9. 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)

    Measured: Baseline, 3 months, 6 months

  10. 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)

    Measured: 6 months

  11. Patient acceptable symptom state (PASS)

    Patient satisfaction with current symptom state, by asking the question: "Taking into account all the activities you have during your daily life, your level of hip pain, and also your functional impairment, do you consider that your current state is satisfactory?" The response options are "yes" or "no"

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start12 Mar 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297148
Sponsor's protocol ID
2023/590816
Other IDs
2023
Acronym
HIPS
Status last verified
Jan 2026
First submitted
29 Feb 2024
Last updated
19 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data, that underlie the results reported in the study, will be available to interested researchers upon reasonable request. Proposals should be directed to the data custodian, principal investigator at mamari@oslomet.no.

Publications

  • Morin Melas T, Bjorneboe J, Juel NG, Wefring ML, Skatteboe S, Killingmo RM, Engebretsen KB, Rathleff MS, Oiestad BE, Soberg HL, Pripp AH, Brox JI, Johnsen MB. Self-management versus usual care for greater trochanteric pain syndrome (the HIPS trial): study protocol for a randomised controlled trial. BMJ Open. 2025 Apr 5;15(4):e090688. doi: 10.1136/bmjopen-2024-090688.

    PubMed 40187788

Questions about this trial

What is this clinical trial studying?

A study testing Self-management in people with GTPS - Greater Trochanteric Pain Syndrome and Gluteal Tendinopathy, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G) (time frame: Baseline, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06297148, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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