Long-term Follow up of Patients With Longstanding Hip and Groin Pain

Hip Pain Chronic Clinical Trial

— Lund LHGP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03490071
• Other study ID #: Lund LHGP
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Lund University
• Contact: Eva Ageberg, PhD
• Phone: +46 46 2224943
• Email: eva.ageberg[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Pain Chronic

Locations

Country	Name	City	State
Sweden	Department of Health Sciences, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Imaging	Plain radiographs with an anterior-posterior projection and Dunn-projection to evaluate hip morphology and detect possible signs of osteoarthrosis.	7 years after baseline
Primary	Changes in the Copenhagen Hip and Groin Outcome Score (HAGOS)	Patient reported outcome regarding hip dysfunction, which includes six subscales; pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activity, and quality of life. The score for each subscale ranges from 0-100, where 0 indicates extreme problems and 100 no problems. Patient Acceptable Symptom State (PASS) will be derived from HAGOS score using previously described cut-off values for the different subscales	3 and 7 years after baseline (cross-sectional study)
Secondary	HSAS - Hip Sports Activity Scale (HSAS)	Patient reported outcome regarding activity level. The scale ranges från 0-8 where 0 indicates the lowest activity and 8 the highest.	3 and 7 years after baseline (cross-sectional study)
Secondary	K-10 questionnaire	Patient reported outcome regarding mental health. This instrument consists of 10 questions, where each question is scored from 1 to 5. The total score is summerized and ranges from 10 to 50, where 10 indicates no problem and 50 severe problems.	3 years after baseline (cross-sectional study)
Secondary	Self-Presentation in Exercise Questionnaire (SPEQ)	Patient reported outcome regarding self image during exercise and consists of 14 questions. Each question is assessed on a 6-point Likert-type scale ranging from 1 (strongly disagree) to 6 (strongly agree). Higher scores represent a greater desire to present oneself as an exerciser and a greater use of strategies to portray oneself as an exerciser.	3 years after baseline (cross-sectional study)
Secondary	The Multidimensional Scale of Perceived Social Support (MSPSS)	The Multidimensional Scale of Perceived Social Support (MSPSS) is designed to measure perceptions of support from 3 sources: Family, Friends, and a Significant Other. The scale is comprised of a total of 12 items, with 4 items for each subscale. The items are scored on 7 point likert scale anging from 1 (very strongly disagree) to 7 (very strongly agree). The mean value tor each subscale are calculated. High score indicates a percetion of good social support.	3 years after baseline (cross-sectional study)
Secondary	Medical Outcomes Study short form 36 (SF-36)	Patient reported outcome regarding general health, which includes eight subscales; vitality, physical functioning, bodily pain, general health perception, physical role functioning, emotional role functioning, social role functioning and mental health. The score for each subscale ranges from 0-100, where 0 indicates extreme problems and 100 no problems.	3 and 7 years after baseline (cross-sectional study)
Secondary	Additional questions regarding treatment, medication, patient satisfaction and perceived change in hip function.	Additional questions about treatment, medication, patient satisfaction and perceived change in hip function will be included for descriptive purpose.	3 and 7 years after baseline (cross-sectional study)