Research Digest

Background: Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials
(RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was
independently observed in observational studies. However, there is an assumption that the clinical course of
symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of
our study was to compare the course of LBP in RCTs and observational studies.

Methods: Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of
systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP.
Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was
used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the
standardised mean change (SMC).

Results: 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms
followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a
smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between
RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7);
13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7);
52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6).

Conclusions: The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational
studies. In addition to a shared ‘natural history’, enrolment of LBP patients in clinical studies is likely to provoke responses
that reflect the nonspecific effects of seeking and receiving care, independent of the study design.

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Abstract

Spinal manipulative therapy (SMT) is effective for some individuals experiencing low back pain; however, the mechanisms are not established regarding the role of placebo. SMT is associated with changes in pain sensitivity, suggesting related altered central nervous system response or processing of afferent nociceptive input. Placebo is also associated with changes in pain sensitivity, and the efficacy of SMT for changes in pain sensitivity beyond placebo has not been adequately considered. We randomly assigned 110 participants with low back pain to receive SMT, placebo SMT, placebo SMT with the instructional set “The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people,” or no intervention. Participants receiving the SMT and placebo SMT received their assigned intervention 6 times over 2 weeks. Pain sensitivity was assessed prior to and immediately following the assigned intervention during the first session. Clinical outcomes were assessed at baseline and following 2 weeks of participation in the study. Immediate attenuation of suprathreshold heat response was greatest following SMT (P = .05, partial η² = .07). Group-dependent differences were not observed for changes in pain intensity and disability at 2 weeks. Participant satisfaction was greatest following the enhanced placebo SMT. This study was registered at www.clinicaltrials.gov under the identifier NCT01168999.

Perspective

The results of this study indicate attenuation of pain sensitivity is greater in response to SMT than the expectation of receiving an SMT. These findings suggest a potential mechanism of SMT related to lessening of central sensitization and may indicate a preclinical effect beyond the expectations of receiving SMT.

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Objectives

To evaluate the association between episodic migraines and the prevalence of myofascial trigger points (MTrPs) in the sternocleidomastoid and upper trapezius, forward head posture (FHP), neck range of motion (ROM) and cervical facet joint stiffness.

Methods

20 physiotherapy students with episodic migraines and 20 age- and sex matched healthy controls were included in this observational case-control study. Demographics and headache status were evaluated through questionnaires. Active neck ROM, presence of MTrPs, and cervical facet joint mobility were assessed by physical examination. FHP was measured using a lateral digital photograph taken in a sitting position.

Results

No significant differences were found in neck ROM measurements and FHP between the migraine and control groups. Significant differences were found in the prevalence of cervical facet joints stiffness in Occiput-C1 (χ² = 4.444, p = 0.035) and C1–C2 (χ² = 10.157, p = 0.001), but not in other segments. Significant differences were found in the prevalence of active and latent MTrPs between the migraine and control subjects in the right trapezius (χ² = 11.649, p = 0.003) and right sternocleidomastoid (χ² = 8.485, p = 0.014).

Conclusions

Our findings support the hypothesis that the prevalence of MTrPs in neck muscles and hypomobility in the upper cervical facet joints are associated with migraines.

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Background

Placebo effect has been largely studied and debated in medicine. Research focused mainly on children and adults but not on newborns. In osteopathy, few studies documented this effect and no research has been conducted in newborns.

Objectives

To assess the presence of placebo effect in newborns using sham osteopathic manipulative treatment.

Design

Randomized control trial.

Setting

Neonatal Intensive Care Unit in Italy.

Interventions

Two groups (103 patients each) of preterm infants aged 29–36 weeks without medical complications received routine pediatric care and osteopathic sham therapy was administrated to the study group only for the entire period of hospitalization.

Main outcome measures

Primary end point was the mean reduction of length of stay at discharge. Secondary objective was the change in daily weight gain.

Results

206 newborns entered the study. No difference between sham and control group was found for the primary outcome length of stay (30.0 ± 20.3; 28.8 ± 18.9; p = 0.70). Multivariate analysis showed no difference between study and control group on length of stay. A negative association was found for gestational age (−2.33; 95% CI −3.81 to −0.85; p = 0.002), birth weight (−0.01; 95% CI −0.02 to −0.01; p < 0.001) and milk volume at study enrollment (−0.02; 95% CI −0.05 to −0.01; p = 0.01).

Conclusions

To the best of our knowledge, this study is the first in the field showing no placebo effect on newborns. Further discussions are opened concerning the age when placebo effect starts.

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Background

The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy. The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain. In addition women and men were compared regarding the occurrence of adverse events.

Methods

Participants were recruited among patients, ages 18–65, seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 767) were randomized to one of three treatment arms 1) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249), 2) manual therapy excluding spinal manipulation (n = 258) and 3) manual therapy excluding stretching (n = 260). Treatments were provided by students in the seventh semester of total eight. Adverse events were measured with a questionnaire after each return visit and categorized in to five levels; 1) short minor, 2) long minor, 3) short moderate, 4) long moderate and 5) serious adverse events, based on the duration and/or severity of the event. Generalized estimating equations were used to examine the association between adverse event and treatments arms.

Results

The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events (OR = 2.19 (95% CI: 1.52-3.15)), and long moderate adverse events (OR = 2.49 (95% CI: 1.77-3.52)) compared to men.

Conclusion

Adverse events after manual therapy are common and transient. Excluding spinal manipulation or stretching do not affect the occurrence of adverse events. The most common adverse event is soreness in the muscles. Women reports more adverse events than men.

Trial registration

This trial was registered in a public registry (Current Controlled Trials) (ISRCTN92249294).

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Abstract

Perspective

Objectives

Methods

Results

Conclusions

Background

Objectives

Design

Setting

Interventions

Main outcome measures

Results

Conclusions

Background

Methods

Results

Conclusion

Trial registration

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