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Tendon InjuriesNCT03401177

Treatment of Early Phase Achilles Tendinopathy - the Effect of NSAIDs

A study testing Naproxen 500 Mg and Heavy resistance training in people with Tendon Injuries and Achilles Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Naproxen 500 Mg and Heavy resistance training
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteDenmark
Study dates
15 Jan 2018to 27 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Activity related pain in the achilles tendon
  • Palpation pain in the achilles tendon
  • Onset of symptoms within the last 3 months

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Bispebjerg Hospital

    Copenhagen, NV, 2400

Other trials in Denmark

About this study

Official title: The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy

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.

Read the 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.

Being tested
Naproxen 500 Mg, Placebo Oral Tablet, Heavy resistance training
Medical subject headings
Tendon Injuries, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naproxen 500 MgDrug

    Also called Naproxen-E Mylan

    Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy

  • Placebo Oral TabletDrug

    Also called Placebo

    Placebo is used, to provide a control to the active group.

  • Heavy resistance trainingOther

    Also called HRT

    Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.

Study groups in NCT03401177
Study groupRoleWhat they receive
Naproxen & Heavy resistance trainingExperimentalNaproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Receives: Drug: Naproxen 500 Mg; Other: Heavy resistance training
Placebo & Heavy resistance trainingPlacebo comparatorPlacebo oral tablet: pill manufactured to mimic naproxen tablet x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.
Receives: Drug: Placebo Oral Tablet; Other: Heavy resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0-3 months

Secondary outcomes (10)

  1. 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.

    Measured: 0-1 week; 0-12 months

  2. Weight

    Weight (kg)

    Measured: 0-3 months

  3. Height

    Height (cm)

    Measured: 0-3 months

  4. Magnetic Resonance Imaging (MRI) - scannings

    3 Tesla MRI scanning of the achilles tendon.

    Measured: 0-3 months

  5. Ultrasonography -Power doppler

    For measuring tendon vascularisation, area with power doppler signal (cm^2)

    Measured: 0-1 week; 0-3 months

  6. Ultrasonography - Greyscale

    Greyscale ultrasound for measuring tendon thickness (mm)

    Measured: 0-1 week; 0-3 months

  7. 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)

    Measured: 0-1 week; 0-3 months; 0-12 months

  8. 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)

    Measured: 0-1 week; 0-3 months; 0-12 months

  9. Questionnaires - activity (intensity)

    Questions on physical activity intensity:

    time consumption for strenuous activity (hours/week).

    Measured: 0-1 week; 0-3 months; 0-12 months

  10. 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)

    Measured: 0-1 week; 0-3 months; 0-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start15 Jan 2018
  3. Primary completion31 Jul 2019
  4. Study completion27 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03401177
Sponsor's protocol ID
BBH-137
Status last verified
Jul 2020
First submitted
19 Dec 2017
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33719579

Questions about this trial

What is this clinical trial studying?

A study testing Naproxen 500 Mg and Heavy resistance training in people with Tendon Injuries and Achilles Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Victorian Institute of Sport Assessment - Achilles (VISA-A) (time frame: 0-3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03401177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.

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