Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs
Primary Purpose
Tendon Injuries, Achilles Tendinopathy, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Naproxen 500 Mg
Placebo Oral Tablet
Heavy resistance training
Sponsored by
About this trial
This is an interventional basic science trial for Tendon Injuries
Eligibility Criteria
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
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Naproxen & Heavy resistance training
Placebo & Heavy resistance training
Arm Description
Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Weight
Weight (kg)
Height
Height (cm)
Magnetic Resonance Imaging (MRI) - scannings
3 Tesla MRI scanning of the achilles tendon.
Ultrasonography -Power doppler
For measuring tendon vascularisation, area with power doppler signal (cm^2)
Ultrasonography - Greyscale
Greyscale ultrasound for measuring tendon thickness (mm)
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)
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)
Questionnaires - activity (intensity)
Questions on physical activity intensity:
time consumption for strenuous activity (hours/week).
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03401177
Brief Title
Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs
Official Title
The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
April 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injuries, Achilles Tendinopathy, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naproxen & Heavy resistance training
Arm Type
Experimental
Arm Description
Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Arm Title
Placebo & Heavy resistance training
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Intervention Type
Drug
Intervention Name(s)
Naproxen 500 Mg
Other Intervention Name(s)
Naproxen-E Mylan
Intervention Description
Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
Placebo is used, to provide a control to the active group.
Intervention Type
Other
Intervention Name(s)
Heavy resistance training
Other Intervention Name(s)
HRT
Intervention Description
Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.
Primary Outcome Measure Information:
Title
Victorian Institute of Sport Assessment - Achilles (VISA-A)
Description
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
Secondary Outcome Measure Information:
Title
Victorian Institute of Sport Assessment - Achilles (VISA-A)
Description
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
Title
Weight
Description
Weight (kg)
Time Frame
0-3 months
Title
Height
Description
Height (cm)
Time Frame
0-3 months
Title
Magnetic Resonance Imaging (MRI) - scannings
Description
3 Tesla MRI scanning of the achilles tendon.
Time Frame
0-3 months
Title
Ultrasonography -Power doppler
Description
For measuring tendon vascularisation, area with power doppler signal (cm^2)
Time Frame
0-1 week; 0-3 months
Title
Ultrasonography - Greyscale
Description
Greyscale ultrasound for measuring tendon thickness (mm)
Time Frame
0-1 week; 0-3 months
Title
Questionnaires - activity (time consumption)
Description
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
Title
Questionnaires - activity (number of sessions)
Description
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
Title
Questionnaires - activity (intensity)
Description
Questions on physical activity intensity:
time consumption for strenuous activity (hours/week).
Time Frame
0-1 week; 0-3 months; 0-12 months
Title
Questionnaires - Numerical Rating Scale (NRS) - Pain
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kjær, Professor
Organizational Affiliation
Institute of Sports Medicine, Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
NV
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33719579
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs
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