NCT03401177|Completed
Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs
The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy
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The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy
Sponsor study identifier
interventional
70
1 country
1
Study Start
January 15, 2018
Actual (reported)Primary Completion
July 31, 2019
Actual (reported)Study Completion
April 27, 2020
Actual (reported)this study evaluates the addition of initial short term NSAID treatment to physiotherapy prescribed exercise treatment in patient with early phase tendinopathy. Half of the participants will initially receive NSAID (naproxen) for 7 days, while the other half will receive a placebo, where after both groups will be subjected to 3 months heavy slow resistance training.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 27, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2017
Actual (reported)January 15, 2018
Actual (reported)January 17, 2018
Actual (reported)July 31, 2019
Actual (reported)April 27, 2020
Actual (reported)Victorian Institute of Sport Assessment - Achilles (VISA-A)
Standardised score of functional capability, in patient with achilles tendinopathy. Total score will be reported; scale (0-100). 100=full functional capacity 0=poor functional capacity.
0-3 months
Victorian Institute of Sport Assessment - Achilles (VISA-A)
0-1 week; 0-12 months
Weight
0-3 months
Height
0-3 months
Magnetic Resonance Imaging (MRI) - scannings
0-3 months
Ultrasonography -Power doppler
0-1 week; 0-3 months
Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy
Bispebjerg Hospital
Copenhagen, NV, 2400, Denmark
Malmgaard-Clausen NM, Jorgensen OH, Hoffner R, Andersen PEB, Svensson RB, Hansen P, Nybing JD, Magnusson SP, Kjaer M. No Additive Clinical or Physiological Effects of Short-term Anti-inflammatory Treatment to Physical Rehabilitation in the Early Phase of Human Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2021 Jun;49(7):1711-1720. doi: 10.1177/0363546521991903. Epub 2021 Mar 15.
Michael Kjær, Professor
Institute of Sports Medicine, Copenhagen
70 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2017
First Posted
January 17, 2018
Study Start
January 15, 2018
Actual (reported)Optimal Treatment of Acute Skeletal Muscle Injury
Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.
Contact the study team to confirm eligibility.
Primary Completion
July 31, 2019
Actual (reported)Study Completion
April 27, 2020
Actual (reported)Last Updated
July 9, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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