The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain

This study has been completed.

Sponsor:

Information provided by:

Frederiksberg University Hospital

ClinicalTrials.gov Identifier:

NCT01346995

First received: May 2, 2011

Last updated: May 3, 2011

Last verified: February 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	May 2, 2011
Last Updated Date	May 3, 2011
Start Date ^ICMJE	February 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 3, 2011)	Isokinetic knee muscle strength [ Time Frame: At baseline and after 8 weeks of exercise ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01346995 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 3, 2011)	One-leg chair rise [ Time Frame: At baseline and after 8 weeks of exercise ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
Official Title ^ICMJE	The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
Brief Summary	The purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Muscle Strength
Intervention ^ICMJE	Other: Experimental knee pain Injection of 1 ml hypertonic saline (5.8%) into the infrapatellar fat pad Other: Non-painful control injections Injection of isotonic saline into the infrapatellar fat pad
Study Arm (s)	Experimental: Experimental Knee Pain Experimental knee pain induced by injections of 1 ml hypertonic saline in to the infrapatellar fat pad Intervention: Other: Experimental knee pain Active Comparator: Control non-painful injections of isotonic saline into the infrapatellar fatpad. Intervention: Other: Non-painful control injections
Publications *	Sørensen TJ, Langberg H, Hodges PW, Bliddal H, Henriksen M. Experimental knee joint pain during strength training and muscle strength gain in healthy subjects: a randomized controlled trial. Arthritis Care Res (Hoboken). 2012 Jan;64(1):108-16.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date	August 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: aged between 20 to 35 years healthy untrained (non-regular exercise participation [i.e. < 1 day/week]) Exclusion Criteria: symptomatic musculoskeletal diseases history of traumatic injuries to muscles, tendons or joints of the lower extremity knee joint pain within a month prior to enrollment
Gender	Both
Ages	20 Years to 35 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01346995
Other Study ID Numbers ^ICMJE	072.07
Has Data Monitoring Committee	No
Responsible Party	Henning Bliddal, The Parker Institute
Study Sponsor ^ICMJE	Frederiksberg University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Frederiksberg University Hospital
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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