Education and Exercise for Patients With Longstanding Hip and Groin Pain

NCT05853640 | Recruiting

• 1 other identifier: 2022-05023-01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Longstanding hip and groin pain (LHGP) is a common and debilitating problem in young to middle aged individuals. These patients often get referred to orthopedic departments. Consensus statements on the management of these patients commonly recommend a physical therapist-led intervention as the first line intervention. However, the optimal content and delivery of this intervention is currently unknown. In this study we will compare the effectiveness of usual care (unstructured physical therapist-led intervention) to a semi-structured, progressive individualized physical therapist-led intervention on hip-related quality of life in people with longstanding hip and groin pain referred to an orthopedic department.

Conditions

Hip Pain Chronic; Femoro Acetabular Impingement; Groin Injury

Keywords

Hip-related pain; Longstanding hip and groin pain; Exercise therapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in iHOT-33 scores at 4 months

  iHOT-33 is a 33 question self-reported outcome scale, measuring hip-related quality of life. This outcome measure has been validated and translated to Swedish. The scores are summed on a 0 (worst)-100 (best) scale.

  The primary outcome will be collected at baseline and at the primary end-point (4 months after baseline).

Secondary Outcomes (23)

• Change in iHOT-33 scores at 1, 2 and 5 years

  This outcome will be collected at baseline and 1,2 and 5 years after baseline.

• Patient acceptable symptom state (PASS)

  This outcome will be collected at the primary endpoint (4 months after baseline). In addition it will also be collected at 1,2 and 5 years after baseline.

• Treatment failure

  This outcome will be collected at the primary endpoint (4 months after baseline). In addition it will also be collected at 1,2 and 5 years after baseline.

• Perceived symptom improvement

  This outcome will be collected at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.

• Patient desire and beliefs regarding surgical intervention

  This outcome will be collected at baseline and at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.

Other Outcomes (3)

• Qualitative interviews - Patients

  The interviews will be conducted within 1 month of baseline data collection for the perceptions of living with, and seeking care for, longstanding hip and groin pain, and within 6 months of primary end point for the perception of the intervention.

• Qualitative interviews - Physical therapists

  The interviews will be conducted during active data collection, when clinicians have treated a minimum of 3 patients in the trial, with an estimated average of 6 months after data collection has started.

• Nested study - psychosocial variables

  Data will be collected at baseline as well as at primary end-point (4 months).

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Participants in this group will undergo usual care at the orthopedic department and will get a recommendation for physical therapist-led treatment in primary care.

Other: Usual care

HIPSTER

EXPERIMENTAL

Participants in this group will undergo usual care at the orthopedic department and will also receive a semi-structured intervention according to the HIPSTER treatment model.

Other: HIPSTER

Interventions

Usual care OTHER

Usual care at the orthopedic department consists of a clinical examination, radiological imaging, and a diagnostic injection. A recommendation to get physical therapy treatment in primary care will be provided, but this intervention will not be controlled by the investigators in any capacity.

Usual care

HIPSTER OTHER

Patients will be provided with usual care at the orthopedic department, which consists of a clinical examination, radiological imaging, and a diagnostic injection. In addition, participants in this group will be referred to physical therapists trained in administering a semi-structured, individualized, progressive treatment. This 16-week intervention targets known physical and psychological impairments in people with long-standing hip and groin pain, using exercise therapy and patient education.

HIPSTER

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged 18-55 years
• Referred to the Dept of Orthopedics due to hip and/or groin pain
• Activity-related unilateral or bilateral groin pain \>3 months
• Pain reproduced with the FADIR test.

You may not qualify if:

• Groin pain originating from any diagnosis with other treatment pathways, i.e., i) Acute traumatic hip injuries (such as hip dislocation, hip fractures); ii) Verified moderate or severe OA (Tönnis grade \>1); iii) Palpable hernia; iv) Low-back pain with a positive straight leg raise test and/or hip and groin pain provoked primarily by repeated motions of the lumbar spine; v) Sacroiliac joint pain with thigh thrust test.
• Co-morbidities potentially interfering with treatment, i.e., i) Co-morbidities overriding the hip and groin-related symptoms and dysfunction (such as other acute lower limb injuries, rheumatoid arthritis etc), ii) Co-morbidities prohibiting physical activity and training (heart disease etc), iii) Current psycho-social disorders requiring treatment.
• Other: i) History of drug abuse within the last year; ii) Not understanding the language of interest (Scandinavian languages, or English).

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Skane University Hospital

Malmo, Sweden

RECRUITING

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Ageberg, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Ageberg, PhD

CONTACT

+46046-2224943; eva.ageberg@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome assessors, and participants will be blinded to group allocation. An independent statistician, blinded to treatment allocation, will perform the statistical analysis. Treatment providers will be blinded to study hypothesis and the content of the different treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 double blind randomized controlled trial, conforming to the CONSORT statement

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: May 11, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)