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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03401177
Other study ID # BBH-137
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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