On 2014 Apr 03, Nicholas Henschke commented:

On behalf of the authors, thank you for your comment and interest in our study. The search strategy used for the systematic review did identify the trial cited in the above comment [1], however, this trial was originally excluded due to insufficient data to allow meta-analysis. It should have been added to the Table of Excluded Studies in the review, citing this reason.

By using a factorial design the trial provides an estimate of the effect of ultrasound therapy compared to sham ultrasound in the presence of other co-interventions (osteopathic manual therapy and sham osteopathic manual therapy). This comparison was deemed sufficiently different to those from other trials in the meta-analysis to warrant inclusion. If data for each cell in the factorial design had been reported [2] some comparisons may have been suitable for inclusion in the meta-analysis.

The trial authors will be contacted and given the opportunity to provide this data for the future updates of this review. This study has now been added to an amended version of the review under "Studies awaiting classification".

References

[1] Licciardone, JC, et al. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med 2013;11(2):122-129.

[2] McAlister, FA, et al. Analysis and reporting of factorial trials: a systematic review. JAMA 2003;289:2545-2553.

On 2014 Mar 17, JOHN LICCIARDONE commented:

It was interesting to read this Cochrane review on therapeutic ultrasound for chronic low back pain. The authors used a search strategy that was designed to be highly sensitive in retrieving the relevant randomized controlled trials that were reported through October 2013. The search identified seven small randomized controlled trials on therapeutic ultrasound for non-specific chronic low back pain involving a total of 362 patients. The authors concluded that there was moderate quality evidence that therapeutic ultrasound improves back-specific function compared with placebo in the short term. There was low quality evidence that therapeutic ultrasound is no better than placebo for short-term pain improvement.

It is unclear why their search strategy failed to identify the results of the OSTEOPATHIC Trial, which were reported in March 2013 1. Therein, 455 patients were randomized to ultrasound therapy or sham ultrasound therapy as part of a randomized controlled trial that used a 2x2 factorial design to assess outcomes at 12 weeks in patients with non-specific chronic low back pain. Osteopathic manual treatment was also compared with sham osteopathic manual treatment in this trial.

As measured by the Roland-Morris Disability Questionnaire, there was no evidence of any benefit with ultrasound therapy in improving back-specific function [1]. Correspondingly, using a visual analogue scale for low back pain and guidelines recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [2] and by the Cochrane Back Review Group [3], the OSTEOPATHIC Trial failed to identify even a small treatment effect with ultrasound therapy in any of its analyses for low back pain reduction [1]. By contrast, osteopathic manual treatment was associated with medium to large treatment effects in this domain [1].

The authors of this Cochrane review concluded that there are few high quality randomized controlled trials assessing the use of ultrasound for improving pain or quality of life in patients with non-specific chronic low back pain. They further commented that future large trials with valid methodology are likely to have an important impact on their confidence in the estimated effect and may change their estimate. Consequently, it would be worthwhile to assess the impact of these OSTEOPATHIC Trial results upon the Cochrane review and its conclusions given that a greater number of patients were enrolled in the OSTEOPATHIC Trial than in all other seven trials combined in the Cochrane review.

References

1. Licciardone, JC, et al. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med 2013;11(2):122-129.
2. Dworkin, RH, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9(2):105-121.
3. Furlan, AD, et al. 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa 1976) 2009;34(18):1929-1941.

On 2014 Mar 17, JOHN LICCIARDONE commented:

It was interesting to read this Cochrane review on therapeutic ultrasound for chronic low back pain. The authors used a search strategy that was designed to be highly sensitive in retrieving the relevant randomized controlled trials that were reported through October 2013. The search identified seven small randomized controlled trials on therapeutic ultrasound for non-specific chronic low back pain involving a total of 362 patients. The authors concluded that there was moderate quality evidence that therapeutic ultrasound improves back-specific function compared with placebo in the short term. There was low quality evidence that therapeutic ultrasound is no better than placebo for short-term pain improvement.

It is unclear why their search strategy failed to identify the results of the OSTEOPATHIC Trial, which were reported in March 2013 1. Therein, 455 patients were randomized to ultrasound therapy or sham ultrasound therapy as part of a randomized controlled trial that used a 2x2 factorial design to assess outcomes at 12 weeks in patients with non-specific chronic low back pain. Osteopathic manual treatment was also compared with sham osteopathic manual treatment in this trial.

As measured by the Roland-Morris Disability Questionnaire, there was no evidence of any benefit with ultrasound therapy in improving back-specific function [1]. Correspondingly, using a visual analogue scale for low back pain and guidelines recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [2] and by the Cochrane Back Review Group [3], the OSTEOPATHIC Trial failed to identify even a small treatment effect with ultrasound therapy in any of its analyses for low back pain reduction [1]. By contrast, osteopathic manual treatment was associated with medium to large treatment effects in this domain [1].

The authors of this Cochrane review concluded that there are few high quality randomized controlled trials assessing the use of ultrasound for improving pain or quality of life in patients with non-specific chronic low back pain. They further commented that future large trials with valid methodology are likely to have an important impact on their confidence in the estimated effect and may change their estimate. Consequently, it would be worthwhile to assess the impact of these OSTEOPATHIC Trial results upon the Cochrane review and its conclusions given that a greater number of patients were enrolled in the OSTEOPATHIC Trial than in all other seven trials combined in the Cochrane review.

References

1. Licciardone, JC, et al. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med 2013;11(2):122-129.
2. Dworkin, RH, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9(2):105-121.
3. Furlan, AD, et al. 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa 1976) 2009;34(18):1929-1941.