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Completed

NCT Number: NCT03401177

Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

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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Key information

Conditions

Tendon Injuries Achilles Tendinopathy Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naproxen 500 Mg

Drug

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

Other names: Naproxen-E Mylan

Placebo oral tablet

Drug

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

Other names: Placebo

Heavy resistance training

Other

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

Other names: HRT

Primary outcomes

  1. Victorian Institute of Sport Assessment - Achilles (VISA-A)

    Time frame: 0-3 months

    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.

Secondary outcomes

  1. Victorian Institute of Sport Assessment - Achilles (VISA-A)

    Time frame: 0-1 week; 0-12 months

    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.

  2. Weight

    Time frame: 0-3 months

    Weight (kg)

  3. Height

    Time frame: 0-3 months

    Height (cm)

  4. Magnetic Resonance Imaging (MRI) - scannings

    Time frame: 0-3 months

    3 Tesla MRI scanning of the achilles tendon.

  5. Ultrasonography -Power doppler

    Time frame: 0-1 week; 0-3 months

    For measuring tendon vascularisation, area with power doppler signal (cm^2)

  6. Ultrasonography - Greyscale

    Time frame: 0-1 week; 0-3 months

    Greyscale ultrasound for measuring tendon thickness (mm)

  7. Questionnaires - activity (time consumption)

    Time frame: 0-1 week; 0-3 months; 0-12 months

    Questions on physical activity: time consumption (hours/week)

    Hours of training/week;

    Hours of training applying load on the achilles tendon/week; Scale (continues)

  8. Questionnaires - activity (number of sessions)

    Time frame: 0-1 week; 0-3 months; 0-12 months

    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)

  9. Questionnaires - activity (intensity)

    Time frame: 0-1 week; 0-3 months; 0-12 months

    Questions on physical activity intensity:

    time consumption for strenuous activity (hours/week).

  10. Questionnaires - Numerical Rating Scale (NRS) - Pain

    Time frame: 0-1 week; 0-3 months; 0-12 months

    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)

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 17, 2018
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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