Clinical trial NCT03401177: Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs
Official title: The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendon Injuries
Achilles Tendinopathy
Inflammation
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: NSAID is effective in short term pain relief in musculoskeletal disorders, but little is known about the long-term effect in early phase tendinopathy, when used as a supplement to treatment as usual, namely heavy slow resistance training and training load reduction. In this study, NSAIDs will be used, which works through COX inhibition, which again inhibits Prostaglandins, in this way investigators attempt to dampen the initial inflammation and pronounced cell activity that is thought to be present in early phase tendinopathy. With this project, it will be attempted to investigate whether initial dampening adds to the effect achieved through heavy load resistance training, which is thought to stimulate structural repair and regeneration in the tendon, by applying appropriate load to the tendon tissue, thereby stimulating the tendon cells to repair and regeneration.

Eligibility criteria: Inclusion Criteria:

* Activity related pain in the achilles tendon
* Palpation pain in the achilles tendon
* Onset of symptoms within the last 3 months

Exclusion Criteria:

* Previous injury in the achilles tendon on the ipsilateral side.
* Recent infection around the achilles tendon
* Previous surgery in the achilles tendon.
* Contraindications for NSAID treatment.
* NSAID treatment for the current injury
* Medication with NSAID interaction

Primary outcomes:
measure: Victorian Institute of Sport Assessment - Achilles (VISA-A)
timeFrame: 0-3 months
Secondary outcomes:
measure: Victorian Institute of Sport Assessment - Achilles (VISA-A)
timeFrame: 0-1 week; 0-12 months
measure: Weight
timeFrame: 0-3 months
measure: Height
timeFrame: 0-3 months
measure: Magnetic Resonance Imaging (MRI) - scannings
timeFrame: 0-3 months
measure: Ultrasonography -Power doppler
timeFrame: 0-1 week; 0-3 months
measure: Ultrasonography - Greyscale
timeFrame: 0-1 week; 0-3 months
measure: Questionnaires - activity (time consumption)
timeFrame: 0-1 week; 0-3 months; 0-12 months
measure: Questionnaires - activity (number of sessions)
timeFrame: 0-1 week; 0-3 months; 0-12 months
measure: Questionnaires - activity (intensity)
timeFrame: 0-1 week; 0-3 months; 0-12 months
measure: Questionnaires - Numerical Rating Scale (NRS) - Pain
timeFrame: 0-1 week; 0-3 months; 0-12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
Study officials:
affiliation: Institute of Sports Medicine, Copenhagen
name: Michael Kjær, Professor
role: STUDY_DIRECTOR
References:
citation: 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.