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Long-term Follow up of Patients With Longstanding Hip and Groin Pain (Lund LHGP)

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ClinicalTrials.gov Identifier: NCT03490071
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University

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 five years after the initial contact with orthopedic surgeon.

Condition or disease
Hip Pain Chronic

Detailed Description:

87 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.

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Study Type : Observational
Estimated Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Three and Five 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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 3, 2022
Estimated Study Completion Date : March 1, 2023



Primary Outcome Measures :
  1. Changes in the Copenhagen Hip and Groin Outcome Score (HAGOS) [ Time Frame: 3 and 5 years after baseline (cross-sectional study) ]
    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.


Secondary Outcome Measures :
  1. HSAS - Hip Sports Activity Scale (HSAS) [ Time Frame: 3 and 5 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.

  2. K-10 questionnaire [ Time Frame: 3 and 5 years after baseline (cross-sectional study) ]
    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. Self-Presentation in Exercise Questionnaire (SPEQ) [ Time Frame: 3 and 5 years after baseline (cross-sectional study) ]
    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.

  4. The Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: 3 and 5 years after baseline (cross-sectional study) ]
    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.

  5. Medical Outcomes Study short form 36 (SF-36) [ Time Frame: 3 and 5 years after baseline (cross-sectional study) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the Department of Orthopedics, Skåne University Hospital, Sweden.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490071


Contacts
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Contact: Eva Ageberg, PhD +46 46 2224943 eva.ageberg@med.lu.se
Contact: Anders Pålsson, MSc +46 733385393 anders.palsson@med.lu.se

Locations
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Sweden
Department of Health Sciences, Lund University Recruiting
Lund, Sweden, 22100
Contact: Eva Ageberg, PhD    +46 46 2224943    eva.ageberg@med.lu.se   
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Eva Ageberg, PhD Lund University

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03490071    
Other Study ID Numbers: Lund LHGP
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
Longstanding hip and groin pain
Patient reported outcome