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CompletedNCT01300754Updated Feb 23, 2011

Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

A Phase 1/2 interventional study of Dextrose Injection and Lidocaine Injection in Osgood-Schlatter Disease, sponsored by Universidad Nacional de Rosario. Completed at 1 site in Argentina. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2011-02-23.

Sponsored by Universidad Nacional de Rosario · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
9 Years to 17 Years
Sex
All
01

Study summary

Objective: To examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to change pain/function/activity levels in adolescent athletes with Osgood-Schlatter Disease (OSD).

Read the detailed description

Patients and methods: Girls ages 9-15 years old and boys ages 10-17 years old will be assigned to either therapist-supervised usual care, or to double-blind injection of 1% lidocaine solution with or without 12.5% dextrose. Injections will be administered monthly for three months. All subjects will then be offered dextrose injections monthly as needed. Change in the Nirschl Pain Phase Scale (NPPS) will serve as the primary outcome measure.

02

Conditions studied

  • Osgood-Schlatter Disease

Keywords

  • Osgood-Schlatter
  • Tendinosis
  • Apophysitis
  • Enthesopathy
  • Dextrose.
03

In context

Osteochondrosis

16 studies on the registry are indexed under Osteochondrosis; 5 are open to participants now.

This study's enrollment of 54 is close to the median of 51 across 13 interventional studies indexed under Osteochondrosis.

Browse Osteochondrosis studies →

Lead sponsor

Universidad Nacional de Rosario is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age:9-15 year old girls and 10-17 year old boys
  • Pain Location: Anterior knee.
  • Sport Type: Jumping or kicking sport.
  • Team Member with Coach: Member of and organized team with a coach.
  • Imitation of exact pain and precise location to the tibial tuberosity with a single leg squat.
  • At least 2 months of formal and gently progressive hamstring stretching, quads strengthening, and gradual sports reintroduction.
  • Pain with sport at least 3 months.

Exclusion criteria

Exclusion Criteria:

  • Patellofemoral crepitus
  • Patellar origin tenderness
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Dextrose

    Procedure: Dextrose Injection

  • Active comparator
    Lidocaine

    Procedure: Lidocaine Injection

  • Active comparator
    Usual Care

    Other: Usual Care

Interventions

  • ProcedureDextrose Injection

    12.5 Dextrose in 1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.

  • ProcedureLidocaine Injection

    1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.

  • OtherUsual Care

    Therapist supervised exercises that are standard of care for Osgood-Schatter Disease as well as relative rest and gradual resumption of pain-limited sport.

06

Study locations

1 site
  • Hospital Provincial de Rosario
    Rosario, Santa Fe, Argentina
07

References and documents

Publications

  • Topol GA, Podesta LA, Reeves KD, Raya MF, Fullerton BD, Yeh HW. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics. 2011 Nov;128(5):e1121-8. doi: 10.1542/peds.2010-1931. Epub 2011 Oct 3. PubMed 21969284 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2006, a primary completion of Sep 2009 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2011
First posted
Feb 23, 2011
Start
Jan 2006
Primary completionActual
Sep 2009
CompletionActual
Sep 2010
Last update
Feb 23, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01300754
Lead sponsor
Universidad Nacional de Rosario
First posted
Feb 23, 2011
Start date
Jan 2006
Primary completion
Sep 2009
Completion
Sep 2010
Last update
Feb 23, 2011

Study contacts

Gaston A Topol, Dr.
principal investigator · Hospital Provincial de Rosario

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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