Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

Not Applicable

Completed

• Conditions: Tendon Injuries; Achilles Tendinopathy; Inflammation
• Interventions: Drug: Placebo Oral Tablet; Drug: Naproxen 500 Mg; Other: Heavy resistance training

• Registration Number: NCT03401177
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2018-01-09
• Study Start: 2018-01-15
• Study First Posted: 2018-01-17
• Primary Completion: 2019-07-31
• Study Completion: 2020-04-27
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naproxen & Heavy resistance training	Heavy resistance training	Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Placebo & Heavy resistance training	Placebo Oral Tablet	Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Placebo & Heavy resistance training	Heavy resistance training	Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Naproxen & Heavy resistance training	Naproxen 500 Mg	Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.

Primary Outcome Measures

Name	Time	Method
Victorian Institute of Sport Assessment - Achilles (VISA-A)	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

Name	Time	Method
Height	0-3 months	Height (cm)
Magnetic Resonance Imaging (MRI) - scannings	0-3 months	3 Tesla MRI scanning of the achilles tendon.
Ultrasonography -Power doppler	0-1 week; 0-3 months	For measuring tendon vascularisation, area with power doppler signal (cm\^2)
Ultrasonography - Greyscale	0-1 week; 0-3 months	Greyscale ultrasound for measuring tendon thickness (mm)
Questionnaires - activity (time consumption)	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)	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)	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	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)
Victorian Institute of Sport Assessment - Achilles (VISA-A)	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	0-3 months	Weight (kg)

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, NV, Denmark