Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Tendon Injuries; Achilles Tendinopathy
• Intervention / Treatment: Drug: Naproxen 500 Mg; Other: Heavy resistance training; Drug: Placebo Oral Tablet

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
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • NV
    • Copenhagen, NV, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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.	Other: Heavy resistance training; Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.; Other Names: HRT; Drug: Placebo Oral Tablet; Placebo is used, to provide a control to the active group.; Other Names: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Study Director: Michael Kjær, Professor, Institute of Sports Medicine, Copenhagen

Publications and helpful links

General Publications

• Malmgaard-Clausen NM, Jorgensen OH, Hoffner R, Andersen PEB, Svensson RB, Hansen P, Nybing JD, Magnusson SP, Kjaer M. No Additive Clinical or Physiological Effects of Short-term Anti-inflammatory Treatment to Physical Rehabilitation in the Early Phase of Human Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2021 Jun;49(7):1711-1720. doi: 10.1177/0363546521991903. Epub 2021 Mar 15.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Inflammation; Tendinopathy; Tendon Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: BBH-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No