NCT03401177

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

December 19, 2017

Last Update Submit

July 8, 2020

Conditions

Tendon InjuriesAchilles TendinopathyInflammation

Outcome Measures

Primary Outcomes (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.

    0-3 months

Secondary Outcomes (10)

  • Victorian Institute of Sport Assessment - Achilles (VISA-A)

    0-1 week; 0-12 months

  • Weight

    0-3 months

  • Height

    0-3 months

  • Magnetic Resonance Imaging (MRI) - scannings

    0-3 months

  • Ultrasonography -Power doppler

    0-1 week; 0-3 months

  • +5 more secondary outcomes

Study Arms (2)

Naproxen & Heavy resistance training

EXPERIMENTAL

Naproxen: 500 mg x 2 daily for 7 days, HRT: 3 months physiotherapy guided training.

Drug: Naproxen 500 MgOther: Heavy resistance 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.

Drug: Placebo Oral TabletOther: Heavy resistance training

Interventions

Naproxen 500 MgDRUG

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

Also known as: Naproxen-E Mylan
Naproxen & Heavy resistance training
Placebo Oral TabletDRUG

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

Also known as: Placebo
Placebo & Heavy resistance training
Heavy resistance trainingOTHER

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

Also known as: HRT
Naproxen & Heavy resistance trainingPlacebo & Heavy resistance training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 33719579DERIVED

MeSH Terms

Conditions

Tendon InjuriesInflammation

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Michael Kjær, Professor

    Institute of Sports Medicine, Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 17, 2018

Study Start

January 15, 2018

Primary Completion

July 31, 2019

Study Completion

April 27, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

DK(1)