Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy

Conditions
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Tendon Injuries, Achilles Tendinopathy, Inflammation

Intervention / Treatment
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* Drug: Naproxen 500 Mg
* Drug: Placebo Oral Tablet
* Other: Heavy resistance training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naproxen & Heavy resistance training<br>Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training. | Drug: Naproxen 500 Mg<br>* Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy<br>* Other names: Naproxen-E Mylan;Other: Heavy resistance training<br>* Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.<br>* Other names: HRT;|
| Placebo Comparator: Placebo & Heavy resistance training<br>Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training. | Drug: Placebo Oral Tablet<br>* Placebo is used, to provide a control to the active group.<br>* Other names: Placebo;Other: Heavy resistance training<br>* Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.<br>* Other names: HRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-1 week; 0-12 months | 
| Weight | Weight (kg) | 0-3 months | 
| Height | Height (cm) | 0-3 months | 
| Magnetic Resonance Imaging (MRI) - scannings | 3 Tesla MRI scanning of the achilles tendon. | 0-3 months | 
| Ultrasonography -Power doppler | For measuring tendon vascularisation, area with power doppler signal (cm^2) | 0-1 week; 0-3 months | 
| Ultrasonography - Greyscale | Greyscale ultrasound for measuring tendon thickness (mm) | 0-1 week; 0-3 months | 
| Questionnaires - activity (time consumption) | Questions on physical activity: time consumption (hours/week) Hours of training/week; Hours of training applying load on the achilles tendon/week; Scale (continues) | 0-1 week; 0-3 months; 0-12 months | 
| Questionnaires - activity (number of sessions) | Questions on physical activity: number of sessions/week Number of training sessions/week. Number of training sessions applying load on the achilles tendon/week; Scale (continues) | 0-1 week; 0-3 months; 0-12 months | 
| Questionnaires - activity (intensity) | Questions on physical activity intensity: time consumption for strenuous activity (hours/week). | 0-1 week; 0-3 months; 0-12 months | 
| Questionnaires - Numerical Rating Scale (NRS) - Pain | Questions on pain, both during activity and during rest. Pain during activity, (NRS); Scale (0-10) Pain after activity, (NRS); Scale (0-10) Pain at rest, (NRS); Scale (0-10) Pain I the morning, (NRS); Scale (0-10) Maximal pain during the past week, (NRS); Scale (0-10) | 0-1 week; 0-3 months; 0-12 months |