NCT06297148

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:

  • 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.
  • To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2024Oct 2026

First Submitted

Initial submission to the registry

February 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

March 12, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

February 29, 2024

Last Update Submit

January 16, 2026

Conditions

Keywords

Greater Trochanteric Pain SyndromeLateral hip painGluteal tendinopathyTrochanteric bursitisSelf-management

Outcome Measures

Primary Outcomes (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.

    Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (11)

  • Numeric rating scale (NRS)

    Baseline, 3 months, 6 months, 12 months

  • Painful sites

    Baseline, 3 months, 6 months, 12 months

  • The Pain Self-Efficacy Questionnaire (PSEQ)

    Baseline, 3 months, 6 months, 12 months

  • EuroQoL-5 dimensions-5 Level (Eq-5D-5L)

    Baseline, 3 months, 6 months, 12 months

  • Hopkins Symptoms checklist-10 (HSCL-10)

    Baseline, 3 months, 6 months, 12 months

  • +6 more secondary outcomes

Study Arms (2)

Self-management

EXPERIMENTAL

The intervention will consist of 3-5 individual sessions over 12 weeks with a physiotherapist. There will be 3 physiotherapists delivering the self-management intervention.

Other: Self-management

Usual care

ACTIVE COMPARATOR

Given standardized information at baseline and free to choose further treatment in primary care.

Other: Usual care

Interventions

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.

Usual care

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.

Self-management

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, 0450, Norway

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Interventions

Self-Management

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 7, 2024

Study Start

March 12, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 5 years following publication.
Access Criteria
To gain access, data requestors will need to sign a data access agreement.

Locations