Patellar Tendinopathy / Jumpers KneeNCT00404469
Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy
A study testing peritendinous corticosteroid injections, eccentric decline squat training and heavy slow resistance training in people with Patellar Tendinopathy / Jumpers Knee, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Patellar Tendinopathy / Jumpers Knee
- What is being tested?
- peritendinous corticosteroid injections, eccentric decline squat training and heavy slow resistance training
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2006to Nov 2007
- 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 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical patellar tendinopathy pain.
- Tendon swelling
- Hypoechoic
- Doppler activity in tendon
Who cannot join
- Previous knee surgery
- diabetes
- arthritis
- previous steroid injections
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen. Dept 8 1st floor. Bispebjerg Hospital
Copenhagen, 2400
About this study
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.
Read the detailed description
3 interventions groups as described above (n=13 in each group) 12 weeks intervention period. Clinical assessments before and after intervention: VAS, VISA, Tendon thickness, Doppler us activity.
Before and after intervention tendon biopsies will be taken and analyzed for crosslinks and fibril diameter. Also tendon mechanical properties will be measured. Tendon and muscle structural properties will be measured with MRI.
Treatment satisfaction will be stated after intervention period.
- Conditions
- Patellar Tendinopathy / Jumpers Knee
- Being tested
- peritendinous corticosteroid injections, eccentric decline squat training, heavy slow resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peritendinous corticosteroid injectionsProcedure or surgery
1 ml of40mg/ml methylprednisolone acetate at 0 and 4 weeks. 2 week observational
eccentric decline squat trainingProcedure or surgery
eccentric decline unilateral squats performed twice daily. for 12 weeks
heavy slow resistance trainingProcedure or surgery
Heavy slow resistance training for knee extensors. 3/week. total of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| CORT | Active comparator | Peritendinous corticosteroid injections at 0 and 4 weeks. 12 weeks total Receives: Procedure: peritendinous corticosteroid injections |
| ECC | Experimental | 12 weeks of eccentric unilateral decline squats Receives: Procedure: eccentric decline squat training |
| HSR | Experimental | Heavy slow resistance training. 3/week. 12 weeks Receives: Procedure: heavy slow resistance training |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startMar 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar Tendinopathy / Jumpers KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mads Kongsgaard, PhD., MSc., Principal investigator, Institute of Sports Medicine, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404469
- Sponsor's protocol ID
- Patellar tendinopathy
- Status last verified
- May 2008
- First submitted
- 27 Nov 2006
- Last updated
- 22 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT00404469
- Acronym / sponsor ID
- Patellar tendinopathy
- Conditions
- Patellar Tendinopathy / Jumpers Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
3 interventions groups as described above (n=13 in each group) 12 weeks intervention period. Clinical assessments before and after intervention: VAS, VISA, Tendon thickness, Doppler us activity.
Before and after intervention tendon biopsies will be taken and analyzed for crosslinks and fibril diameter. Also tendon mechanical properties will be measured. Tendon and muscle structural properties will be measured with MRI.
Treatment satisfaction will be stated after intervention period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CORT | Active comparator | Procedure: peritendinous corticosteroid injectionsPeritendinous corticosteroid injections at 0 and 4 weeks. 12 weeks total |
| ECC | Experimental | Procedure: eccentric decline squat training12 weeks of eccentric unilateral decline squats |
| HSR | Experimental | Procedure: heavy slow resistance trainingHeavy slow resistance training. 3/week. 12 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical patellar tendinopathy pain.
- Tendon swelling
- Hypoechoic
- Doppler activity in tendon
Key exclusion criteria (4 listed)
- Previous knee surgery
- diabetes
- arthritis
- previous steroid injections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peritendinous corticosteroid injections1 ml of40mg/ml methylprednisolone acetate at 0 and 4 weeks. 2 week observational | Procedure or surgery | CORT |
| eccentric decline squat trainingeccentric decline unilateral squats performed twice daily. for 12 weeks | Procedure or surgery | ECC |
| heavy slow resistance trainingHeavy slow resistance training for knee extensors. 3/week. total of 12 weeks | Procedure or surgery | HSR |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mads Kongsgaard, PhD., MSc. principal investigator
Institute of Sports Medicine, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peritendinous corticosteroid injections, eccentric decline squat training and heavy slow resistance training in people with Patellar Tendinopathy / Jumpers Knee, 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 4 inclusion and 4 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 22 May 2008. 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. 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.
Where can I read the original study information?
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 22 May 2008.