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Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

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ClinicalTrials.gov Identifier: NCT03401177
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Nikolaj Mølkjær Malmgaard-Clausen, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Tendon Injuries Achilles Tendinopathy Inflammation Drug: Naproxen 500 Mg Drug: Placebo Oral Tablet Other: Heavy resistance training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: Naproxen & Heavy resistance training
Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Drug: Naproxen 500 Mg
Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy
Other Name: Naproxen-E Mylan

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

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.
Drug: Placebo Oral Tablet
Placebo is used, to provide a control to the active group.
Other Name: Placebo

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401177


Contacts
Contact: Nikolaj M. Malmgaard-Clausen, MD 38635069 nmal0015@regionh.dk

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, NV, Denmark, 2400
Contact: Nikolaj M. Malmgaard-Clausen, MD    38635069    nmal0015@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Study Director: Michael Kjær, Professor Institute of Sports Medicine, Copenhagen

Responsible Party: Nikolaj Mølkjær Malmgaard-Clausen, Medical Doctor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03401177     History of Changes
Other Study ID Numbers: BBH-137
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tendon Injuries
Muscular Diseases
Inflammation
Tendinopathy
Pathologic Processes
Musculoskeletal Diseases
Wounds and Injuries
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action