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Improving methodology when analyzing shockwave evidence: evidence holds the key
The Spine Journal 15 (2015) 1703
Letter to the Editor Improving methodology when analyzing shockwave evidence: evidence holds the key To the Editor: We thank Dr. Ramon et al. for their interest in our systematic review (SR). Answers to the points raised are as follows: 1. This SR focused on randomized clinical trials (RCTs) assessing the efficacy, effectiveness, and cost/effectiveness of technologies applying ‘‘mechanical vibration for treating low back pain’’ (‘‘ie, vibrotherapy’’) [1]. It did not intend to provide data on ‘‘ESWT costs’’ or information related to the ‘‘mechanism of action’’ for procedures ‘‘known to the ESWT scientific world.’’ 2. The SR found no data on cost/effectiveness because none of the RCTs had assessed cost-effectiveness. Moreover, data on cost/effectiveness are likely to be irrelevant for a therapy, which has not proven effective. 3. The literature on vibrotherapy included the use of vibration at high frequency (above 20,000 Hz, which generates heat and is called ‘‘ultrasound’’) and low frequency (10–250 Hz, which causes an oscillatory pressured‘‘shock waves’’), as generated by ‘‘muscle relaxation machines,’’ vibratory platforms, and the ‘‘Fair-Med.’’ Only three RCTs on ultrasound and one on the ‘‘Fair-Med’’ were found [1]. Therefore, conclusions on the efficacy, effectiveness, and cost/effectiveness of ‘‘shockwave therapy’’ were based on the latter [2]. 4. The RCT on the Fair-Med device was published in 2008 [2]. It is unfortunate that it did not comply with the treatment standards which the ‘‘International Society for Medical Shockwave Treatment’’ issued 6 years later, in November 2014 [3]. This may indeed disqualify Fair-Med from being labeled as ‘‘shockwave therapy’’ according to the current International Society for Medical Shockwave Treatment’s standards, but it does not challenge the conclusions of the SR. 5. The SR concluded that, by 2011, there was no evidence supporting the clinical use of vibrotherapy. This conclusion remains valid in 2015, as no new RCTs on the effect of ultrasound or shockwave therapy (irrespective of how the latter is defined) for LBP are available. Therefore, we do not see the practical implications of the comments from Dr. Ramon et al. 6. We welcome the commitment of EWST promoters to standardize the definition for ‘‘shockwave therapy,’’ and encourage them to implement this definition in high-quality
1529-9430/Ó 2015 Elsevier Inc. All rights reserved.
RCTs assessing the efficacy, efficiency, and also effectiveness of this technology for treating LBP. This approach is likely to be the best way of effectively promoting ‘‘a better research excellence framework,’’ which ‘‘benefits evidence-based medicine,’’ and to ensure ‘‘that our patients receive the best care.’’ In the absence of such evidence, we think that debate is futile.
References [1] Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost/effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J 2011;11:966–77. [2] Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord 2008;9:97. [3] International Society for Medical Shockwave Treatment (ISMST). In: Principles. Basics physics. Available at: http://www.ismst.com/start. htm. Accessed November 10, 2014.
Jesus Seco, MD, PhD Institute of Biomedicine (IBIOMED) University of Le on Campus Universitario 24071, Leon, Spain University of the Basque Country, Spain Spanish Back Pain Research Network Francisco M. Kovacs, MD, PhD Research Department Kovacs Foundation Paseo de Mallorca 36, 3 , 1a. 07012 Palma de Mallorca, Spain Spanish Back Pain Research Network Gerard Urrutia, MD, PhD Iberoamerican Cochrane Center-Servei d’Epidemiologia Clınica i Salut P ublica Institut d’Investigacio Biomedica Sant Pau Sant Antoni M. Claret 171 Barcelona, Catalonia 08041, Spain CIBER Epidemiologıa y Salud Publica (CIBERESP), Spain FDA device/drug status: Not applicable. Author disclosures: JS: Nothing to disclose. FMK: Nothing to disclose. GU: Nothing to disclose. http://dx.doi.org/10.1016/j.spinee.2015.05.015
Letter to the Editor Improving methodology when analyzing shockwave evidence: evidence holds the key To the Editor: We thank Dr. Ramon et al. for their interest in our systematic review (SR). Answers to the points raised are as follows: 1. This SR focused on randomized clinical trials (RCTs) assessing the efficacy, effectiveness, and cost/effectiveness of technologies applying ‘‘mechanical vibration for treating low back pain’’ (‘‘ie, vibrotherapy’’) [1]. It did not intend to provide data on ‘‘ESWT costs’’ or information related to the ‘‘mechanism of action’’ for procedures ‘‘known to the ESWT scientific world.’’ 2. The SR found no data on cost/effectiveness because none of the RCTs had assessed cost-effectiveness. Moreover, data on cost/effectiveness are likely to be irrelevant for a therapy, which has not proven effective. 3. The literature on vibrotherapy included the use of vibration at high frequency (above 20,000 Hz, which generates heat and is called ‘‘ultrasound’’) and low frequency (10–250 Hz, which causes an oscillatory pressured‘‘shock waves’’), as generated by ‘‘muscle relaxation machines,’’ vibratory platforms, and the ‘‘Fair-Med.’’ Only three RCTs on ultrasound and one on the ‘‘Fair-Med’’ were found [1]. Therefore, conclusions on the efficacy, effectiveness, and cost/effectiveness of ‘‘shockwave therapy’’ were based on the latter [2]. 4. The RCT on the Fair-Med device was published in 2008 [2]. It is unfortunate that it did not comply with the treatment standards which the ‘‘International Society for Medical Shockwave Treatment’’ issued 6 years later, in November 2014 [3]. This may indeed disqualify Fair-Med from being labeled as ‘‘shockwave therapy’’ according to the current International Society for Medical Shockwave Treatment’s standards, but it does not challenge the conclusions of the SR. 5. The SR concluded that, by 2011, there was no evidence supporting the clinical use of vibrotherapy. This conclusion remains valid in 2015, as no new RCTs on the effect of ultrasound or shockwave therapy (irrespective of how the latter is defined) for LBP are available. Therefore, we do not see the practical implications of the comments from Dr. Ramon et al. 6. We welcome the commitment of EWST promoters to standardize the definition for ‘‘shockwave therapy,’’ and encourage them to implement this definition in high-quality
1529-9430/Ó 2015 Elsevier Inc. All rights reserved.
RCTs assessing the efficacy, efficiency, and also effectiveness of this technology for treating LBP. This approach is likely to be the best way of effectively promoting ‘‘a better research excellence framework,’’ which ‘‘benefits evidence-based medicine,’’ and to ensure ‘‘that our patients receive the best care.’’ In the absence of such evidence, we think that debate is futile.
References [1] Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost/effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. Spine J 2011;11:966–77. [2] Barker KL, Elliott CJ, Sackley CM, Fairbank JC. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet Disord 2008;9:97. [3] International Society for Medical Shockwave Treatment (ISMST). In: Principles. Basics physics. Available at: http://www.ismst.com/start. htm. Accessed November 10, 2014.
Jesus Seco, MD, PhD Institute of Biomedicine (IBIOMED) University of Le on Campus Universitario 24071, Leon, Spain University of the Basque Country, Spain Spanish Back Pain Research Network Francisco M. Kovacs, MD, PhD Research Department Kovacs Foundation Paseo de Mallorca 36, 3 , 1a. 07012 Palma de Mallorca, Spain Spanish Back Pain Research Network Gerard Urrutia, MD, PhD Iberoamerican Cochrane Center-Servei d’Epidemiologia Clınica i Salut P ublica Institut d’Investigacio Biomedica Sant Pau Sant Antoni M. Claret 171 Barcelona, Catalonia 08041, Spain CIBER Epidemiologıa y Salud Publica (CIBERESP), Spain FDA device/drug status: Not applicable. Author disclosures: JS: Nothing to disclose. FMK: Nothing to disclose. GU: Nothing to disclose. http://dx.doi.org/10.1016/j.spinee.2015.05.015