Treatment of Early Phase Achilles Tendinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2020-04-27

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.

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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.

Conditions

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Tendon Injuries Achilles Tendinopathy Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Naproxen & Heavy resistance training

Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.

Group Type EXPERIMENTAL

Naproxen 500 Mg

Intervention Type DRUG

Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy

Heavy resistance training

Intervention Type OTHER

Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.

Placebo & Heavy resistance training

Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo is used, to provide a control to the active group.

Heavy resistance training

Intervention Type OTHER

Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.

Interventions

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Naproxen 500 Mg

Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy

Intervention Type DRUG

Placebo Oral Tablet

Placebo is used, to provide a control to the active group.

Intervention Type DRUG

Heavy resistance training

Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.

Intervention Type OTHER

Other Intervention Names

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Naproxen-E Mylan Placebo HRT

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No