An interventional study of Naproxen 500 Mg and Placebo Oral Tablet in Tendon Injuries, Achilles Tendinopathy and Inflammation, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Basic science
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.
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.
100 studies on the registry are indexed under Tendon Injuries; 27 are open to participants now.
This study's enrollment of 70 is above the median of 44 across 70 interventional studies indexed under Tendon Injuries.
Browse Tendon Injuries studies →Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Drug: Naproxen 500 Mg · Other: Heavy resistance training
Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Drug: Placebo Oral Tablet · Other: Heavy resistance training
Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy
Also known as: Naproxen-E Mylan
Placebo is used, to provide a control to the active group.
Also known as: Placebo
Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.
Also known as: HRT
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.
Time frame: 0-3 months
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.
Time frame: 0-1 week; 0-12 months
Weight
Weight (kg)
Time frame: 0-3 months
Height
Height (cm)
Time frame: 0-3 months
Magnetic Resonance Imaging (MRI) - scannings
3 Tesla MRI scanning of the achilles tendon.
Time frame: 0-3 months
Ultrasonography -Power doppler
For measuring tendon vascularisation, area with power doppler signal (cm\^2)
Time frame: 0-1 week; 0-3 months
Ultrasonography - Greyscale
Greyscale ultrasound for measuring tendon thickness (mm)
Time frame: 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)
Time frame: 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)
Time frame: 0-1 week; 0-3 months; 0-12 months
Questionnaires - activity (intensity)
Questions on physical activity intensity: time consumption for strenuous activity (hours/week).
Time frame: 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)
Time frame: 0-1 week; 0-3 months; 0-12 months
Plan to share: Undecided
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Naproxen