Education and Exercise for Patients With Longstanding Hip and Groin Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorLund University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Usual care
Other interventionUsual 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.
HIPSTER
Other interventionPatients 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.
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Usual careActive comparator 1 intervention
Group B: HIPSTERExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
The primary outcome will be collected at baseline and at the primary end-point (4 months after baseline).Secondary outcomes
1
Change in iHOT-33 scores at 1, 2 and 5 years
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.
Time frame
This outcome will be collected at baseline and 1,2 and 5 years after baseline.2
Patient acceptable symptom state (PASS)
The patient acceptable symptom state (PASS) will be collected using a dichotomized question ("Taking into account your hip and groin function and pain, and how it affects your daily life, including your ability to participate in sport and social activities, do you consider that your current state is acceptable if it remained like that for the rest of your life?").
Time frame
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.3
Treatment failure
Treatment failure will be collected using a dichotomized question "Do you consider your current state so unsatisfactory that you think your treatment has failed?".
Time frame
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.4
Perceived symptom improvement
Perceived symptom improvement will be collected using a 7-point Global rating of change (GROC) scale, ranging from -3 (a lot worse), to +3 (a lot better).
Time frame
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.Other outcomes
1
Qualitative interviews - Patients
A sub-group of participants (about 15 or until saturation) will be interviewed on-line in a semi-standardised fashion, about their perceptions of living with, and seeking care for, longstanding hip and groin pain. Participants randomized to the experimental arm (n=10), will also be asked to participate in interviews/workshops about their perception of the intervention.
Time frame
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.2
Qualitative interviews - Physical therapists
Physical therapists trained in delivering the intervention in the experimental arm will be interviewed in a semi-standardised fashion, about their experiences of treating this patient population and their experience of delivering the experimental intervention.
Time frame
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.3
Nested study - psychosocial variables
A subgroup (n=20 from each treatment arm) will answer additional questionnaires, as part of an exploratory nested study on the psychosocial response to patient education and treatment. 17 questions will cover 7 contructs (Support, Fear, Motivation, Self-efficacy, Expectations, Enablement \& Acceptability), using Likert scales.
Time frame
Data will be collected at baseline as well as at primary end-point (4 months).Sponsors and contacts
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Source ClinicalTrials.gov