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Effectiveness of Dextrose Injection for Osgood-Schlatter Disease

U

Universidad Nacional de Rosario

Status and phase

Completed
Phase 2
Phase 1

Conditions

Osgood-Schlatter Disease

Treatments

Procedure: Dextrose Injection
Procedure: Lidocaine Injection
Other: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT01300754
UNRosario

Details and patient eligibility

About

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).

Full 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.

Enrollment

54 patients

Sex

All

Ages

9 to 17 years old

Volunteers

No Healthy Volunteers

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

  • Patellofemoral crepitus
  • Patellar origin tenderness

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

54 participants in 3 patient groups

Dextrose
Active Comparator group
Treatment:
Procedure: Dextrose Injection
Lidocaine
Active Comparator group
Treatment:
Procedure: Lidocaine Injection
Usual Care
Active Comparator group
Treatment:
Other: Usual Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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