NCT00404469

Brief Summary

We will investigate the effect of peritendinous corticosteroid injections, eccentric training and heavy resistance training in male patellar tendinopathy patients. The purpose is to compare the clinical effect of these three treatments in a randomised controlled trial. Also we wish to investigate the treatment mechanisms responsible for the effectiveness of the three treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

First QC Date

November 27, 2006

Last Update Submit

May 21, 2008

Conditions

Patellar Tendinopathy / Jumpers Knee

Study Arms (3)

CORT

ACTIVE COMPARATOR

Peritendinous corticosteroid injections at 0 and 4 weeks. 12 weeks total

Procedure: peritendinous corticosteroid injections

ECC

EXPERIMENTAL

12 weeks of eccentric unilateral decline squats

Procedure: eccentric decline squat training

HSR

EXPERIMENTAL

Heavy slow resistance training. 3/week. 12 weeks

Procedure: heavy slow resistance training

Interventions

peritendinous corticosteroid injectionsPROCEDURE

1 ml of40mg/ml methylprednisolone acetate at 0 and 4 weeks. 2 week observational

CORT
eccentric decline squat trainingPROCEDURE

eccentric decline unilateral squats performed twice daily. for 12 weeks

ECC
heavy slow resistance trainingPROCEDURE

Heavy slow resistance training for knee extensors. 3/week. total of 12 weeks

HSR

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical patellar tendinopathy pain.
  • Tendon swelling
  • Hypoechoic
  • Doppler activity in tendon

You may not qualify if:

  • Previous knee surgery
  • diabetes
  • arthritis
  • previous steroid injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen. Dept 8 1st floor. Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Study Officials

  • Mads Kongsgaard, PhD., MSc.

    Institute of Sports Medicine, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 28, 2006

Study Start

March 1, 2006

Study Completion

November 1, 2007

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

DK(1)