Clinical trial NCT03490071: Long-term Follow up of Patients With Longstanding Hip and Groin Pain
Official title: Three and Seven Year Follow-up of Patients Reported Symptoms, Function and Quality of Life in Patients With Longstanding Hip and Groin Pain Referred to Tertiary Care. A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Pain Chronic
Keywords: Longstanding hip and groin pain
Patient reported outcome
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Department of Orthopedics, Skåne University Hospital, Sweden.

Brief summary: In this longitudinal cohort study including young to middle aged people with longstanding hip and groin pain (LHGP) referred to tertiary care, we will collect data of patient reported symptoms, function and quality of life three and seven years after the initial contact with orthopedic surgeon.

Detailed description: 81 physically active patients (18-55 years) with (LHGP) who were enrolled in a cross-sectional study (Diagnosis and functional limitations in the young to middle-aged physically active population with long-standing hip/groin pain: A cross-sectional study) during the period October 2014 to January 2017 will be recruited to this longitudinal cohort study.

A research coordinator will contact the patients and provide them with written and oral information about the study. Patients who accept to participate will electronically complete the following questionnaires. The same questionnaires were included at baseline, i.e., in the cross-sectional study.

* Copenhagen Hip and Groin Outcome Score (HAGOS)
* HSAS - Hip Sports Activity Scale (HSAS)
* Patient Specific Functional Scale
* Medical Outcomes Study short form 36 (SF-36)
* K-10 questionnaire
* Self-Presentation in Exercise Questionnaire (SPEQ)
* Multidimensional Scale of Perceived Social Support (MSPSS)

Additional questions about treatment, medication, patient satisfaction and perceived change in hip function will be included.

For descriptive purposes, the mean difference (95% CI), or median (quartiles), between baseline and follow-up assessments will be used as appropriate. Separate linear regression models will be used to evaluate the change in each variable compared to baseline values.

Eligibility criteria: At baseline, the following inclusion and exclusion criteria were used:

Inclusion criteria:

* Unilateral or bilateral hip/groin pain \>3 months
* Age 18-55 years
* No previous hip surgery

Exclusion criteria:

* Hip pathology (i.e., Perthes' disease)
* Verified moderate or severe osteoarthritis (OA) (Tönnis grade \>1)
* Palpable hernia
* Low-back pain with a positive Lasègue test
* MRI-verified lower back/spine pathology (i.e., spinal stenosis, disc herniation)
* Other musculoskeletal co-morbidities overriding the hip-related symptoms and dysfunction
* Co-morbidities excluding physical activity and training
* Psycho-social disorders
* Drug abuse
* Not understanding the language of interest.

Primary outcomes:
measure: Changes in the Copenhagen Hip and Groin Outcome Score (HAGOS)
timeFrame: 3 and 7 years after baseline (cross-sectional study)
Secondary outcomes:
measure: HSAS - Hip Sports Activity Scale (HSAS)
timeFrame: 3 and 7 years after baseline (cross-sectional study)
measure: K-10 questionnaire
timeFrame: 3 years after baseline (cross-sectional study)
measure: Self-Presentation in Exercise Questionnaire (SPEQ)
timeFrame: 3 years after baseline (cross-sectional study)
measure: The Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 3 years after baseline (cross-sectional study)
measure: Medical Outcomes Study short form 36 (SF-36)
timeFrame: 3 and 7 years after baseline (cross-sectional study)
measure: Additional questions regarding treatment, medication, patient satisfaction and perceived change in hip function.
timeFrame: 3 and 7 years after baseline (cross-sectional study)
Other outcomes:
measure: Imaging
timeFrame: 7 years after baseline
Locations:
city: Lund
country: Sweden
facility: Department of Health Sciences, Lund University
Study officials:
affiliation: Lund University
name: Eva Ageberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: