- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03490071
Long-term Follow up of Patients With Longstanding Hip and Groin Pain (Lund LHGP)
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eva Ageberg, PhD
- Phone Number: +46 46 2224943
- Email: eva.ageberg@med.lu.se
Study Contact Backup
- Name: Anders Pålsson, PhD
- Phone Number: +46 733385393
- Email: anders.palsson@med.lu.se
Study Locations
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Lund, Sweden, 22100
- Recruiting
- Department of Health Sciences, Lund University
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Contact:
- Eva Ageberg, PhD
- Phone Number: +46 46 2224943
- Email: eva.ageberg@med.lu.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Copenhagen Hip and Groin Outcome Score (HAGOS)
Time Frame: 3 and 7 years after baseline (cross-sectional study)
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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
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3 and 7 years after baseline (cross-sectional study)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HSAS - Hip Sports Activity Scale (HSAS)
Time Frame: 3 and 7 years after baseline (cross-sectional study)
|
Patient reported outcome regarding activity level.
The scale ranges från 0-8 where 0 indicates the lowest activity and 8 the highest.
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3 and 7 years after baseline (cross-sectional study)
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K-10 questionnaire
Time Frame: 3 years after baseline (cross-sectional study)
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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.
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3 years after baseline (cross-sectional study)
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Self-Presentation in Exercise Questionnaire (SPEQ)
Time Frame: 3 years after baseline (cross-sectional study)
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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.
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3 years after baseline (cross-sectional study)
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The Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: 3 years after baseline (cross-sectional study)
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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.
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3 years after baseline (cross-sectional study)
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Medical Outcomes Study short form 36 (SF-36)
Time Frame: 3 and 7 years after baseline (cross-sectional study)
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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.
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3 and 7 years after baseline (cross-sectional study)
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Additional questions regarding treatment, medication, patient satisfaction and perceived change in hip function.
Time Frame: 3 and 7 years after baseline (cross-sectional study)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging
Time Frame: 7 years after baseline
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Plain radiographs with an anterior-posterior projection and Dunn-projection to evaluate hip morphology and detect possible signs of osteoarthrosis.
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7 years after baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eva Ageberg, PhD, Lund University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Lund LHGP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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