Sham treatment effects in manual therapy trials on back pain patients: a systematic review and pairwise meta-analysis.

OBJECTIVE: To assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development. DESIGN: Systematic review and meta-analysis. METHODS AND ANALYSIS: Different databases were screened up to 20 August 2020. Randomised controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included.Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology and reflexology) and to no treatment. Primary outcomes were BP improvement, success of blinding and adverse effect (AE). Secondary outcomes were number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score. RESULTS: 24 trials were included involving 2019 participants. Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique.Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55). CONCLUSIONS: MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings.Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects. PROSPERO REGISTRATION NUMBER: CRD42020198301.

How type and number of training sessions influence the reliability of palpation.

INTRODUCTION: Accurate and reliable palpation is needed to identify anatomical landmarks as well as to assess motion and dysfunctions. Although different trials suggested that training might increase reliability of palpation, the poor dependability of the examined tests may show the need to review the teaching methods to improve palpatory accuracy? The aims of this study were: METHODS: 82 examiners with different years of experience were enrolled from AIMO institute. Two different type of training sessions were performed (individual and group training). A total of 5 training sessions were performed during 5 weeks and 5 different models with a similar BMI were used. A uni-variated statistical analysis was used to evaluate the main effect of type and number of trainings, a multi-variated analysis was used to verify cross-effects. RESULTS: Overall results show moderate reliability for the correct detection of the position of the heel lift (Random probability being 33%, GT = 58.6% and SIPS = 57.1%, both P-value < 0.001). No difference was shown between the types of training (p-value GT = 0.503, p-value PSIS = 1) and no overall improvement was shown after the first training (P-value(GT) = 0.25, P-value(PSIS) = 0.96). The professional group improved the reliability during the training sessions starting from substantial reliability and ended with an almost perfect reliability (P-value GT = 0.0029, P-Value PSIS<0.001). Whereas the 3rd 4th and 5th showed a decreased performance. CONCLUSIONS: Type of training sessions seems not to influence reliability of palpation accuracy. The improvement of reliability during the training sessions seems to be related to the experience of examiners, which plays an important role in reliability and the learning experience.

Osteopathic Manual Treatment for Amyotrophic Lateral Sclerosis: A Feasibility Pilot Study.

BACKGROUND: Current interventions in amyotrophic lateral sclerosis (ALS) are focused on supporting quality of life (QoL) and easing pain with a multidisciplinary approach. OBJECTIVE: Primary aim of this pilot work assessed feasibility, safety, tolerability and satisfaction of osteopathic manual treatment (OMT) in 14 ALS outpatients. METHODS: Patients were randomized according to an initial single-blind design (12 weeks, T0-T1), in order to receive OMT (weekly for 4 weeks, and fortnightly for the following 8 weeks) versus usual-care (n=7 each group), followed by an OMT open period (T1-T2, once a week for 8 weeks, n=10). Secondary aims included blind osteopathic assessment of somatic dysfunctions (SD) for goal attainment scale (GAS) calculation, Brief Pain Inventory-short form and McGill QoL-16 items. RESULTS: OMT was demonstrated feasible and safe and patients displayed high satisfaction (T1-VAS=8.34 ± 0.46; T2-VAS=8.52 ± 0.60). Considering secondary aims no significant differences emerged. Finally, at study entry (T0), a cervico-dorsal SD was found in 78% of ALS patients versus 28% of healthy matched controls (p<0.01). CONCLUSION: OMT was found feasible, safe and satisfactory in ALS. The lack of secondary aim differences can be due to the limited sample size. OMT could be an interesting option to explore in ALS.