Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain

• ClinicalTrials.gov Identifier: NCT00716729
• Recruitment Status: Completed
• First Posted: July 16, 2008
• Last Update Posted: October 19, 2010
• Sponsor: Amager Hospital
• Collaborator: Lundbeck Foundation
• Information provided by: Amager Hospital

Tracking Information

• First Submitted Date: July 15, 2008
• First Posted Date: July 16, 2008
• Last Update Posted Date: October 19, 2010
• Study Start Date: July 2009
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 15, 2008): Patient reported questionnaire [ Time Frame: 1-2 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: July 15, 2008): Strength measurement for the hip [ Time Frame: 1 year ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain
• Official Title: Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain

Brief Summary

The aim of this study is to develop an evaluative questionnaire, to evaluate patients with hip and groin disability, and a strength measurement for the hip, for patients with hip and groin disability.

Both measurement instrument are aimed for evaluating the natural course and different treatment modalities in patients with hip and groin disability.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with hip and/groin pain for more than 8 weeks

Condition

• Hip Disability
• Groin Disability

• Intervention: Not Provided
• Study Groups/Cohorts: Pateints with longstanding hip and/groin pain
• Publications *: Thorborg K, Hölmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937. Erratum in: Br J Sports Med. 2011 Jul;45(9):742.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 15, 2008): 150
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2010
• Actual Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Hip and/groin pain more than 6 weeks
• Physically active

Exclusion Criteria:

• Systemic diseases
• Physically inactive

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00716729
• Other Study ID Numbers: H-C-2007-0129
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Physiotherapist Kristian Thorborg, Amager Hospital
• Study Sponsor: Amager Hospital
• Collaborators: Lundbeck Foundation
• Investigators: Not Provided
• PRS Account: Amager Hospital
• Verification Date: July 2008