Inflammation Clinical Trial
Official title:
The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy
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 |
Verified date | July 2020 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg Hospital | Copenhagen | NV |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital |
Denmark,
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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