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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen & Heavy resistance training | Experimental | Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training. |
|
| Placebo & Heavy resistance training | Placebo Comparator | Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen 500 Mg | Drug | Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kjær, Professor | Institute of Sports Medicine, Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | NV | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33719579 | Derived | Malmgaard-Clausen NM, Jorgensen OH, Hoffner R, Andersen PEB, Svensson RB, Hansen P, Nybing JD, Magnusson SP, Kjaer M. No Additive Clinical or Physiological Effects of Short-term Anti-inflammatory Treatment to Physical Rehabilitation in the Early Phase of Human Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2021 Jun;49(7):1711-1720. doi: 10.1177/0363546521991903. Epub 2021 Mar 15. |
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| ID | Term |
|---|---|
| D013708 | Tendon Injuries |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo Oral Tablet | Drug | Placebo is used, to provide a control to the active group. |
|
|
| Heavy resistance training | Other | Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment. |
|
|
Weight (kg) |
| 0-3 months |
| Height | Height (cm) | 0-3 months |
| Magnetic Resonance Imaging (MRI) - scannings | 3 Tesla MRI scanning of the achilles tendon. | 0-3 months |
| Ultrasonography -Power doppler | For measuring tendon vascularisation, area with power doppler signal (cm^2) | 0-1 week; 0-3 months |
| Ultrasonography - Greyscale | Greyscale ultrasound for measuring tendon thickness (mm) | 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) | 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) | 0-1 week; 0-3 months; 0-12 months |
| Questionnaires - activity (intensity) | Questions on physical activity intensity: time consumption for strenuous activity (hours/week). | 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) | 0-1 week; 0-3 months; 0-12 months |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |