Treatment of Early Phase Achilles Tendinopathy – the Effect of NSAIDs

Overview

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.

Full Title of Study: “The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2019

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.

Interventions

  • Drug: Naproxen 500 Mg
    • Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy
  • Drug: Placebo Oral Tablet
    • Placebo is used, to provide a control to the active group.
  • Other: Heavy resistance training
    • Heavy slow resistance training – used in both groups subsequent to the initial week of NSAID or placebo treatment.

Arms, Groups and Cohorts

  • Experimental: Naproxen & Heavy resistance training
    • Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • Weight
    • Time Frame: 0-3 months
    • Weight (kg)
  • Height
    • Time Frame: 0-3 months
    • Height (cm)
  • Magnetic Resonance Imaging (MRI) – scannings
    • Time Frame: 0-3 months
    • 3 Tesla MRI scanning of the achilles tendon.
  • Ultrasonography -Power doppler
    • Time Frame: 0-1 week; 0-3 months
    • For measuring tendon vascularisation, area with power doppler signal (cm^2)
  • Ultrasonography – Greyscale
    • Time Frame: 0-1 week; 0-3 months
    • Greyscale ultrasound for measuring tendon thickness (mm)
  • 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)
  • 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)
  • 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).
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bispebjerg Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nikolaj Mølkjær Malmgaard-Clausen, Medical Doctor – Bispebjerg Hospital
  • Overall Official(s)
    • Michael Kjær, Professor, Study Director, Institute of Sports Medicine, Copenhagen

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