Achilles Tendinopathy RCT
Achilles Tendinopathy RCT
SUMMARY 2009 RCT by Yelland et al.
Dr. Yelland and colleagues reported a study in 2009, with reference listed below. This RCT is a high-quality study, meaning there were low (good) ratings for bias. This study compared dextrose injection with a tiny needle about the Achilles tendon with a specialized form of physical therapy that involves painful repeated stretching of the Achilles tendon called eccentric lengthening exercises. Both treatments resulted in substantial functional benefit measured by a standard measure of Achilles tendon function called the VISA-A(Achilles). Eccentric lengthening exercise is an effective form of therapy, well respected by sports medicine physicians. Therefore, this study shows dextrose injection is equally effective. It is essential to be aware that dextrose methods to treat the Achilles tendon have improved considerably since the study, but dextrose injection studies typically have little or no financial support, and procedures must be kept simple. For those that grade studies using the Strength of Recommendation (SOR) criteria, this would be considered a favorable treatment comparison study (B- level of evidence). Evidence B- or above is sufficient that evidence-based physicians should be referring their patients to receive it.
Yelland MJ, Sweeting KR, Lyftogt JA, Ng SK, Scuffham PA, Evans KA. Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial. Br J Sports Med 2009;45:421-8. (The study abstract is listed at the bottom of this page for medical readers
Dr. Yelland and colleagues reported a study in 2009, with reference listed below. This RCT is a high-quality study, meaning there were low (good) ratings for bias. This study compared dextrose injection with a tiny needle about the Achilles tendon with a specialized form of physical therapy that involves painful repeated stretching of the Achilles tendon called eccentric lengthening exercises. Both treatments resulted in substantial functional benefit measured by a standard measure of Achilles tendon function called the VISA-A(Achilles). Eccentric lengthening exercise is an effective form of therapy, well respected by sports medicine physicians. Therefore, this study shows dextrose injection is equally effective. It is essential to be aware that dextrose methods to treat the Achilles tendon have improved considerably since the study, but dextrose injection studies typically have little or no financial support, and procedures must be kept simple. For those that grade studies using the Strength of Recommendation (SOR) criteria, this would be considered a favorable treatment comparison study (B- level of evidence). Evidence B- or above is sufficient that evidence-based physicians should be referring their patients to receive it.
Yelland MJ, Sweeting KR, Lyftogt JA, Ng SK, Scuffham PA, Evans KA. Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial. Br J Sports Med 2009;45:421-8. (The study abstract is listed at the bottom of this page for medical readers
Further randomized trials have not been pubioshed since Dr. Yelland's work.
RCT #1: Yelland MJ, Sweeting KR, Lyftogt JA, et al. Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial. Br J Sports Med. 2009;45(5):421-428.
ABSTRACT
OBJECTIVE: To compare the effectiveness and cost-effectiveness of eccentric loading exercises (ELE) with prolotherapy injections used singly and in combination for painful Achilles tendinosis.
DESIGN: A single-blinded randomized clinical trial. The primary outcome measure was the VISA-A questionnaire with a minimum clinically important change (MCIC) of 20 points on a 100 point scale.
SETTING: Five Australian private primary care centres.
PARTICIPANTS: 43 patients with painful mid-portion Achilles tendinosis commenced and 40 completed the treatment protocols.
INTERVENTIONS: Participants were randomized to a 12 week program of ELE (n=15), or prolotherapy injections of hypertonic glucose with lidocaine alongside the affected tendon (n=14) or combined treatment (n=14). Main outcome measurements: VISA-A, pain, stiffness and limitation of activity scores and treatment costs were assessed prospectively over 12 months.
RESULTS: At 12 months, the proportions of participants achieving the MCIC for VISA-A scores were 73% for ELE, 79% for prolotherapy and 86% for combined treatment. Mean (95% CI) increases in VISA-A scores at 12 months were 23.7 (15.6 to 31.9) for ELE, 27.5 (12.8 to 42.2) for prolotherapy and 41.1 (29.3 to 52.9) for combined treatment. At 6 weeks and 12 months, these increases were significantly less for ELE than for combined treatment. Compared with ELE, reductions in stiffness and limitation of activity occurred earlier with prolotherapy and reductions in pain, stiffness and limitation of activity occurred earlier with combined treatment. Combined treatment had the lowest incremental cost per additional responder (AU$1539) compared with ELE.
CONCLUSIONS: For Achilles tendinosis, prolotherapy and particularly ELE combined with prolotherapy give more rapid improvements in symptoms than ELE alone but long term VISA-A scores are similar.
SUPPLEMENTARY NOTES BY DR REEVES: ELE is a standard care of treatment for Achilles tendinosis with a high success rate so this study compared peri-tendinous injection of dextrose with a treatment with already well documented effectiveness. Patients had semiacute or chronic symptoms with 6 weeks or more of symptomatic mid-substance Achilles tendinopathy with at least moderate severity with a Victorian Institute of Sport Assessment-Achilles (VISA-A) score of <80 for athletes and <70 for non-athletes, (Higher scores are better). Statistically, participants had statistically similar baseline characteristics.
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 compare the effectiveness and cost-effectiveness of eccentric loading exercises (ELE) with prolotherapy injections used singly and in combination for painful Achilles tendinosis.
DESIGN: A single-blinded randomized clinical trial. The primary outcome measure was the VISA-A questionnaire with a minimum clinically important change (MCIC) of 20 points on a 100 point scale.
SETTING: Five Australian private primary care centres.
PARTICIPANTS: 43 patients with painful mid-portion Achilles tendinosis commenced and 40 completed the treatment protocols.
INTERVENTIONS: Participants were randomized to a 12 week program of ELE (n=15), or prolotherapy injections of hypertonic glucose with lidocaine alongside the affected tendon (n=14) or combined treatment (n=14). Main outcome measurements: VISA-A, pain, stiffness and limitation of activity scores and treatment costs were assessed prospectively over 12 months.
RESULTS: At 12 months, the proportions of participants achieving the MCIC for VISA-A scores were 73% for ELE, 79% for prolotherapy and 86% for combined treatment. Mean (95% CI) increases in VISA-A scores at 12 months were 23.7 (15.6 to 31.9) for ELE, 27.5 (12.8 to 42.2) for prolotherapy and 41.1 (29.3 to 52.9) for combined treatment. At 6 weeks and 12 months, these increases were significantly less for ELE than for combined treatment. Compared with ELE, reductions in stiffness and limitation of activity occurred earlier with prolotherapy and reductions in pain, stiffness and limitation of activity occurred earlier with combined treatment. Combined treatment had the lowest incremental cost per additional responder (AU$1539) compared with ELE.
CONCLUSIONS: For Achilles tendinosis, prolotherapy and particularly ELE combined with prolotherapy give more rapid improvements in symptoms than ELE alone but long term VISA-A scores are similar.
SUPPLEMENTARY NOTES BY DR REEVES: ELE is a standard care of treatment for Achilles tendinosis with a high success rate so this study compared peri-tendinous injection of dextrose with a treatment with already well documented effectiveness. Patients had semiacute or chronic symptoms with 6 weeks or more of symptomatic mid-substance Achilles tendinopathy with at least moderate severity with a Victorian Institute of Sport Assessment-Achilles (VISA-A) score of <80 for athletes and <70 for non-athletes, (Higher scores are better). Statistically, participants had statistically similar baseline characteristics.
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 |
High |
Low |
Low |
Unclear |
Computer generated random table |
Randomization generated and administered by a separate statistics center |
Open label trial |
Outcome assessor blinded |
4/43 [<10%] dropped out, but intention to treat utilized. |
No protocol was pre-announced |