Osgood-Schatter disease
RCT #1: Topol GA, Podesta LA, Reeves KD, et al. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics 2011;128:e1121-8
ABSTRACT
OBJECTIVE: To examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to reduce sport alteration and sport-related symptoms in adolescent athletes with Osgood-Schlatter disease.
PATIENTS AND METHODS: Girls aged 9 to 15 and boys aged 10 to 17 were randomly assigned to either therapist-supervised usual care or double-blind injection of 1% lidocaine solution with or without 12.5% dextrose. Injections were administered monthly for 3 months. All subjects were then offered dextrose injections monthly as needed. Unaltered sport (Nirschl Pain Phase Scale < 4) and asymptomatic sport (Nirschl Pain Phase Scale = 0) were the threshold goals.
RESULTS: Sixty-five knees in 54 athletes were treated. Compared with usual care at 3 months, unaltered sport was more common in both dextrose-treated (21 of 21 vs 13 of 22; P = .001) and lidocaine-treated (20 of 22 vs 13 of 22; P = .034) knees, and asymptomatic sport was more frequent in dextrose-treated knees than either lidocaine-treated (14 of 21 vs 5 of 22; P = .006) or usual-care-treated (14 of 21 vs 3 of 22; P < .001) knees. At 1 year, asymptomatic sport was more common in dextrose-treated knees than knees treated with only lidocaine (32 of 38 vs 6 of 13; P = .024) or only usual care (32 of 38 vs 2 of 14; P < .0001).
CONCLUSIONS: Our results suggest superior symptom-reduction efficacy of injection therapy over usual care in the treatment of Osgood-Schlatter disease in adolescents. A significant component of the effect seems to be associated with the dextrose component of a dextrose/lidocaine solution. Dextrose injection over the apophysis and patellar tendon origin was safe and well tolerated and resulted in more rapid and frequent achievement of unaltered sport and asymptomatic sport than usual care.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
ABSTRACT
OBJECTIVE: To examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to reduce sport alteration and sport-related symptoms in adolescent athletes with Osgood-Schlatter disease.
PATIENTS AND METHODS: Girls aged 9 to 15 and boys aged 10 to 17 were randomly assigned to either therapist-supervised usual care or double-blind injection of 1% lidocaine solution with or without 12.5% dextrose. Injections were administered monthly for 3 months. All subjects were then offered dextrose injections monthly as needed. Unaltered sport (Nirschl Pain Phase Scale < 4) and asymptomatic sport (Nirschl Pain Phase Scale = 0) were the threshold goals.
RESULTS: Sixty-five knees in 54 athletes were treated. Compared with usual care at 3 months, unaltered sport was more common in both dextrose-treated (21 of 21 vs 13 of 22; P = .001) and lidocaine-treated (20 of 22 vs 13 of 22; P = .034) knees, and asymptomatic sport was more frequent in dextrose-treated knees than either lidocaine-treated (14 of 21 vs 5 of 22; P = .006) or usual-care-treated (14 of 21 vs 3 of 22; P < .001) knees. At 1 year, asymptomatic sport was more common in dextrose-treated knees than knees treated with only lidocaine (32 of 38 vs 6 of 13; P = .024) or only usual care (32 of 38 vs 2 of 14; P < .0001).
CONCLUSIONS: Our results suggest superior symptom-reduction efficacy of injection therapy over usual care in the treatment of Osgood-Schlatter disease in adolescents. A significant component of the effect seems to be associated with the dextrose component of a dextrose/lidocaine solution. Dextrose injection over the apophysis and patellar tendon origin was safe and well tolerated and resulted in more rapid and frequent achievement of unaltered sport and asymptomatic sport than usual care.
RISK OF BIAS TABLE USING COCHRANE CRITERIA (Modified from Reeves KD, Sit RWS, Rabago D. Dextrose Prolotherapy: A narrative review of basic science and clinical research, and best treatment recommendations. Phys Med Rehabil Clin N Am; 2016; 27(4); 783-823;. DOI 10.1016/j.pmr.2016.06.001)
Sequence Generation |
Allocation Concealment |
Blinding of Participants & Researchers |
Blinding of Outcome Assessment |
Incomplete Outcome Data Addressed |
Selective Data Reporting |
Low |
Unclear |
Low |
Low |
Low |
Unclear |
A random numbers table was used for assignment |
Relevant information was not reported |
Identical control solution prepared in manner that blinded the subjects and treating/evaluating physicians |
Outcome assessor blinded |
No loss to follow- up |
No protocol was pre-announced |
SUMMARY Topol et al. Osgood Schlatter RCT
Topol et al. conducted a 3 arm RCT comparing usual care or double blind injection of 1% lidocaine solution with or without 12.5% dextrose. Pre-teens and teens with chronic anterior knee pain localized to the tibial tuberosity with a single leg squat received treatment at 0,1 and 2 months, and all groups were offered dextrose injection after 3 months by request. The primary measure for assessment was the 0-7 Nirschl Pain Phase Scale (NPPS), chosen because score “0” indicates both no pain and no stiffness, consistent with full symptom resolution. A 0-10 NRS pain score was the secondary measure. Data were collected at 3 months (blinded) and 1 year (open-label).
Participants had statistically similar baseline characteristics. DPT resulted in more improvement of the NPPS score at 3 months than either lidocaine injection or usual care (3.9±0.3 points vs 2.4±0.3 points vs 1.2±.4 points; p<.05) and lidocaine injection was superior to usual care (p<.05). At 1 year 32/38 (84%) of knees treated with DPT were asymptomatic (NPPS = 0) compared to 6/13 (46%) or 2/14 (14%) of knees receiving lidocaine injection or usual care throughout the year. (Fig.25)
Topol et al. conducted a 3 arm RCT comparing usual care or double blind injection of 1% lidocaine solution with or without 12.5% dextrose. Pre-teens and teens with chronic anterior knee pain localized to the tibial tuberosity with a single leg squat received treatment at 0,1 and 2 months, and all groups were offered dextrose injection after 3 months by request. The primary measure for assessment was the 0-7 Nirschl Pain Phase Scale (NPPS), chosen because score “0” indicates both no pain and no stiffness, consistent with full symptom resolution. A 0-10 NRS pain score was the secondary measure. Data were collected at 3 months (blinded) and 1 year (open-label).
Participants had statistically similar baseline characteristics. DPT resulted in more improvement of the NPPS score at 3 months than either lidocaine injection or usual care (3.9±0.3 points vs 2.4±0.3 points vs 1.2±.4 points; p<.05) and lidocaine injection was superior to usual care (p<.05). At 1 year 32/38 (84%) of knees treated with DPT were asymptomatic (NPPS = 0) compared to 6/13 (46%) or 2/14 (14%) of knees receiving lidocaine injection or usual care throughout the year. (Fig.25)