Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

Inflammation Clinical Trial

Official title:

The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401177
• Other study ID #: BBH-137
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: April 27, 2020

Study information

• Verified date: July 2020
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 27, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Inflammation
• Tendinopathy
• Tendon Injuries

Intervention

Drug:
• Naproxen 500 Mg
Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy
• 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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Weight	Weight (kg)	0-3 months
Secondary	Height	Height (cm)	0-3 months
Secondary	Magnetic Resonance Imaging (MRI) - scannings	3 Tesla MRI scanning of the achilles tendon.	0-3 months
Secondary	Ultrasonography -Power doppler	For measuring tendon vascularisation, area with power doppler signal (cm^2)	0-1 week; 0-3 months
Secondary	Ultrasonography - Greyscale	Greyscale ultrasound for measuring tendon thickness (mm)	0-1 week; 0-3 months
Secondary	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
Secondary	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
Secondary	Questionnaires - activity (intensity)	Questions on physical activity intensity: time consumption for strenuous activity (hours/week).	0-1 week; 0-3 months; 0-12 months
Secondary	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