LATERAL EPICONDYLOSIS
RCT # 1: Rabago D, Lee KS, Ryan M, et al. Hypertonic dextrose and morrhuate sodium injections (prolotherapy) for lateral epicondylosis (tennis elbow): results of a single-blind, pilot-level, randomized controlled trial. Am J Phys Med Rehabil 2013;92:587-96.
ABSTRACT
OBJECTIVE:Chronic lateral epicondylosis is common, debilitating, and often refractory. Prolotherapy (PrT) is an injection therapy for tendinopathy. The efficacy of two PrT solutions for chronic lateral epicondylosis was evaluated.
DESIGN:This study is a three-arm randomized controlled trial. Twenty-six adults (32 elbows) with chronic lateral epicondylosis for 3 mos or longer were randomized to ultrasound-guided PrT with dextrose solution, ultrasound-guided PrT with dextrose-morrhuate sodium solution, or watchful waiting ("wait and see"). The primary outcome was the Patient-Rated Tennis Elbow Evaluation (100 points) at 4, 8, and 16 wks (all groups) and at 32 wks (PrT groups). The secondary outcomes included pain-free grip strength and magnetic resonance imaging severity score.
RESULTS:The participants receiving PrT with dextrose and PrT with dextrose-morrhuate reported improved Patient-Rated Tennis ElbowEvaluation composite and subscale scores at 4, 8, and/or 16 wks compared with those in the wait-and-see group (P < 0.05). At 16 wks, compared with baseline, the PrT with dextrose and PrT with dextrose-morrhuate groups reported improved composite Patient-Rated TennisElbow Evaluation scores by a mean (SE) of 18.7 (9.6; 41.1%) and 17.5 (11.6; 53.5%) points, respectively. The grip strength of the participants receiving PrT with dextrose exceeded that of the PrT with dextrose-morrhuate and the wait and see at 8 and 16 wks (P < 0.05). There were no differences in magnetic resonance imaging scores. Satisfaction was high; there were no adverse events.
CONCLUSIONS:PrT resulted in safe, significant improvement of elbow pain and function compared with baseline status and follow-up data and the wait-and-see control group. This pilot study suggests the need for a definitive trial.
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:Chronic lateral epicondylosis is common, debilitating, and often refractory. Prolotherapy (PrT) is an injection therapy for tendinopathy. The efficacy of two PrT solutions for chronic lateral epicondylosis was evaluated.
DESIGN:This study is a three-arm randomized controlled trial. Twenty-six adults (32 elbows) with chronic lateral epicondylosis for 3 mos or longer were randomized to ultrasound-guided PrT with dextrose solution, ultrasound-guided PrT with dextrose-morrhuate sodium solution, or watchful waiting ("wait and see"). The primary outcome was the Patient-Rated Tennis Elbow Evaluation (100 points) at 4, 8, and 16 wks (all groups) and at 32 wks (PrT groups). The secondary outcomes included pain-free grip strength and magnetic resonance imaging severity score.
RESULTS:The participants receiving PrT with dextrose and PrT with dextrose-morrhuate reported improved Patient-Rated Tennis ElbowEvaluation composite and subscale scores at 4, 8, and/or 16 wks compared with those in the wait-and-see group (P < 0.05). At 16 wks, compared with baseline, the PrT with dextrose and PrT with dextrose-morrhuate groups reported improved composite Patient-Rated TennisElbow Evaluation scores by a mean (SE) of 18.7 (9.6; 41.1%) and 17.5 (11.6; 53.5%) points, respectively. The grip strength of the participants receiving PrT with dextrose exceeded that of the PrT with dextrose-morrhuate and the wait and see at 8 and 16 wks (P < 0.05). There were no differences in magnetic resonance imaging scores. Satisfaction was high; there were no adverse events.
CONCLUSIONS:PrT resulted in safe, significant improvement of elbow pain and function compared with baseline status and follow-up data and the wait-and-see control group. This pilot study suggests the need for a definitive trial.
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 |
Low |
Unclear |
Low |
Low |
Low |
Computer-generated randomization |
Randomization generated and administered by a separate statistical center |
Relevant information was not reported |
Outcome assessor blinded, identical solution |
No data was lost to follow-up |
Measures agree with Clinical trial registration) |
SUMMARY of Rabago et al lateral epicondylosis RCT
Rabago et al. compared DPT versus injection of dextrose plus sodium morrhuate versus delayed treatment in a 3-arm trial with masked injection arms. (Fig 32, table 6) Participants received treatment at 1, 4 and 8 weeks with data collection at 16 weeks, at which time those in the wait and see group were offered DPT as their incentive for participation. The prolotherapy groups were then followed to 32 weeks. Effects were assessed using the composite Patient Rated Tennis Elbow Evaluation (PTREE) score, which has pain (5 item) and function (10 item) subscales, and dynamometer-measured grip strength in pounds.
At 16 weeks the dextrose-morrhuate group improved significantly more than the wait and see group on the composite PRTEE (17.5[54%] vs 9.3[18%]; p<.05), (Figure 33) and the dextrose group outperformed the wait and see group on the function subscale of the PRTEE.(7.3 vs 5.4; p < .05), and further improvement was noted at 32 weeks. Grip strength improvement at 16 weeks in the dextrose group was significantly greater than either the dextrose-morrhuate or wait and see groups (65.0 vs 0.9 vs 18.7 pounds; p < .05) (Figure 34). At 32 weeks the difference between the two injection groups was no longer significant for grip strength improvement (69.5 pounds [dextrose] vs 38.6 pounds [dextrose-morrhuate] p>.05). (Figure 34)
Rabago et al. compared DPT versus injection of dextrose plus sodium morrhuate versus delayed treatment in a 3-arm trial with masked injection arms. (Fig 32, table 6) Participants received treatment at 1, 4 and 8 weeks with data collection at 16 weeks, at which time those in the wait and see group were offered DPT as their incentive for participation. The prolotherapy groups were then followed to 32 weeks. Effects were assessed using the composite Patient Rated Tennis Elbow Evaluation (PTREE) score, which has pain (5 item) and function (10 item) subscales, and dynamometer-measured grip strength in pounds.
At 16 weeks the dextrose-morrhuate group improved significantly more than the wait and see group on the composite PRTEE (17.5[54%] vs 9.3[18%]; p<.05), (Figure 33) and the dextrose group outperformed the wait and see group on the function subscale of the PRTEE.(7.3 vs 5.4; p < .05), and further improvement was noted at 32 weeks. Grip strength improvement at 16 weeks in the dextrose group was significantly greater than either the dextrose-morrhuate or wait and see groups (65.0 vs 0.9 vs 18.7 pounds; p < .05) (Figure 34). At 32 weeks the difference between the two injection groups was no longer significant for grip strength improvement (69.5 pounds [dextrose] vs 38.6 pounds [dextrose-morrhuate] p>.05). (Figure 34)
A literature update as of December, 2020, revealed no additonal RCTs on lateral epicondylsis using dextrose prolotherapy
Metaanalysis: Dong W, Goost H, Lin XB, et al. Injection therapies for lateral epicondylalgia: a systematic review and Bayesian network meta-analysis. Br J Sports Med. 2016;50(15):900-908.
ABSTRACT
BACKGROUND: There are many injection therapies for lateral epicondylalgia but there has been no previous comprehensive comparison, based on the Bayesian method.
METHODS: The MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched for appropriate literature. The outcome measurement was the pain score. Direct comparisons were performed using the pairwise meta-analysis, and network meta-analysis, based on a Bayesian model, was used to calculate the results of all of the potentially possible comparisons and rank probabilities. A sensitivity analysis was performed by excluding low-quality studies. The inconsistency of the model was assessed by means of the node-splitting method. Metaregression was used to assess the relationship between the sample size and the treatment effect.
RESULTS: All of the injection treatments showed a trend towards better effects than placebo. Additionally, the peppering technique did not add additional benefits when combined with other treatments. No significant changes were observed by excluding low-quality studies in the sensitivity analysis. No significant inconsistencies were found according to the inconsistency analysis, and metaregression revealed that the sample size was not associated with the treatment effects.
CONCLUSIONS: Some commonly used injection therapies can be considered treatment candidates for lateral epicondylalgia, such as botulinum toxin, platelet-rich plasma and autologous blood injection, but corticosteroid is not recommended. Hyaluronate injection and prolotherapy might be more effective, but their superiority must be confirmed by more research. The peppering technique is not helpful in injection therapies.
SUMMARY: Dong et al lateral epicondylosis metaanalysis
Dong et al after a systematic review and Bayesian network meta-analysis of the literature on all treatments for lateral epicondylosis summarized that “Hyaluronate injection and prolotherapy are the most effective treatments according to our review, but more evidence for their superiority is still needed. ”
ABSTRACT
BACKGROUND: There are many injection therapies for lateral epicondylalgia but there has been no previous comprehensive comparison, based on the Bayesian method.
METHODS: The MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched for appropriate literature. The outcome measurement was the pain score. Direct comparisons were performed using the pairwise meta-analysis, and network meta-analysis, based on a Bayesian model, was used to calculate the results of all of the potentially possible comparisons and rank probabilities. A sensitivity analysis was performed by excluding low-quality studies. The inconsistency of the model was assessed by means of the node-splitting method. Metaregression was used to assess the relationship between the sample size and the treatment effect.
RESULTS: All of the injection treatments showed a trend towards better effects than placebo. Additionally, the peppering technique did not add additional benefits when combined with other treatments. No significant changes were observed by excluding low-quality studies in the sensitivity analysis. No significant inconsistencies were found according to the inconsistency analysis, and metaregression revealed that the sample size was not associated with the treatment effects.
CONCLUSIONS: Some commonly used injection therapies can be considered treatment candidates for lateral epicondylalgia, such as botulinum toxin, platelet-rich plasma and autologous blood injection, but corticosteroid is not recommended. Hyaluronate injection and prolotherapy might be more effective, but their superiority must be confirmed by more research. The peppering technique is not helpful in injection therapies.
SUMMARY: Dong et al lateral epicondylosis metaanalysis
Dong et al after a systematic review and Bayesian network meta-analysis of the literature on all treatments for lateral epicondylosis summarized that “Hyaluronate injection and prolotherapy are the most effective treatments according to our review, but more evidence for their superiority is still needed. ”