Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article II): a meta-analysis relating methods to trial results

Hohenschurz-Schmidt, David; Draper-Rodi, Dr Jerry; Vase, Prof Lene; Scott, Dr Whitney; McGregor, Prof Alison; Soliman, Dr Nadia; MacMillan, Andrew; Olivier, Axel; Cherian, Cybill Ann; Corcoran, Daniel; Abbey, Dr Hilary; Freigang, Sascha; Chan, Jessica; Phalip, Jules; Sørensen, Lea Nørgaard; Delafin, Maite; Baptista, Margarida; Medforth, Naomi R; Ruffini, Nuria; Andresen, Stephanie Skøtt; Ytier, Sylvain; Ali, Dorota; Hobday, Harriet; Santosa, Anak Agung Ngurah Agung Adhiyoga; Vollert, Dr Jan; Rice, Prof Andrew SC

doi:10.1097/j.pain.0000000000002730

Cited by 21 publications

(30 citation statements)

References 91 publications

(156 reference statements)

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“… 70 The inability to distinguish the placebo from the real treatment is desirable to limit interpretation bias, particularly in a mechanistic trial as in the present study. 99 However, the sham SMT may rely on specific mechanisms that overlap with those of real SMT, leading to treatment effects. 20 99 Accordingly, the sham SMT should not be considered as an inert placebo and the lack of between-group differences should be interpreted with caution, with a potential risk for type II errors.…”

Section: Discussionmentioning

confidence: 99%

Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial

2023

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IntroductionChronic low back pain (CLBP) is a highly prevalent and disabling condition. Identifying subgroups of patients afflicted with CLBP is a current research priority, for which a classification system based on pain mechanisms was proposed. Spinal manipulative therapy (SMT) is recommended for the management of CLBP. Yet, little data are available regarding its mechanisms of action, making it difficult to match this intervention to the patients who may benefit the most. It was suggested that SMT may influence mechanisms associated with central sensitisation. Therefore, classifying patients with CLBP according to central sensitisation mechanisms may help predict their response to SMT.Methods and analysisThis protocol describes a randomised placebo-controlled trial aiming to examine which variables linked to central sensitisation may help predict the clinical response to SMT in a cohort of patients with CLBP. One hundred patients with chronic primary low back pain will be randomised to receive 12 sessions of SMT or placebo SMT over a 4-week period. Pain intensity and disability will be assessed as primary outcomes after completing the 4-week treatment (primary endpoint), and at 4-week and 12-week follow-ups. Baseline values of two pain questionnaires, lumbar pressure pain thresholds, concentrations of an inflammatory cytokine and expectations of pain relief will be entered as predictors of the response to SMT in a multiple regression model. Changes in these variables after treatment will be used in a second multiple regression model. The reference values of these predictors will be measured from 50 age and sex-matched healthy controls to allow interpretation of values in patients. Mixed analyses of variance will also be conducted to compare the primary outcomes and the predictors between groups (SMT vs placebo) over time (baseline vs post-treatment).Ethics and disseminationEthical approval was granted by the Fundación Jiménez Díaz Clinical Research Ethics Committee.Trial registration numberNCT05162924.

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Section: Discussionmentioning

confidence: 99%

Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial

2023

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“…A notable challenge in trial design in the field of manual therapy and exercise therapy research is the intrinsic difficulty in patient and therapist blinding, and a limitation to this systematic review is that the included trials rarely evaluated the patient-blinding effectiveness. Consequently, even in sham-controlled trials it remains unclear whether the influence of patient expectations was adequately controlled [20][21][22]. Some Fig.…”

Section: Discussionmentioning

confidence: 99%

“…A common concern in manual and exercise therapy studies is the lack of blinding of patients, providers, or both [ 20 , 21 ]. Obscuring treatment allocation from patients, and in particular therapists, is inherently difficult due to the complex and participatory nature of most interventions [ 22 ].…”

Section: Methodsmentioning

confidence: 99%

The effectiveness of manual and exercise therapy on headache intensity and frequency among patients with cervicogenic headache: a systematic review and meta-analysis

et al. 2022

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Background Cervicogenic headache is a secondary headache, and manual therapy is one of the most common treatment choices for this and other types of headache. Nonetheless, recent guidelines on the management of cervicogenic headache underlined the lack of trials comparing manual and exercise therapy to sham or no-treatment controls. The main objective of this systematic review and meta-analysis was to assess the effectiveness of different forms of manual and exercise therapy in people living with cervicogenic headache, when compared to other treatments, sham, or no treatment controls. Methods Following the PRISMA guidelines, the literature search was conducted until January 2022 on MEDLINE, CENTRAL, DOAJ, and PEDro. Randomized controlled trials assessing the effects of manual or exercise therapy on patients with cervicogenic headache with headache intensity or frequency as primary outcome measures were included. Study selection, data extraction and Risk of Bias (RoB) assessment were done in duplicate. GRADE was used to assess the quality of the evidence. Results Twenty studies were included in the review, with a total of 1439 patients. Common interventions were spinal manipulation, trigger point therapy, spinal mobilization, scapulo-thoracic and cranio-cervical exercises. Meta-analysis was only possible for six manual therapy trials with sham comparators. Data pooling showed moderate-to-large effects in favour of manual therapy for headache frequency and intensity at short-term, small-to-moderate for disability at short-term, small-to-moderate for headache intensity and small for headache frequency at long-term. A sensitivity meta-analysis of low-RoB trials showed small effects in favor of manual therapy in reducing headache intensity, frequency and disability at short and long-term. Both trials included in the sensitivity meta-analysis studied spinal manipulation as the intervention of interest. GRADE assessment showed moderate quality of evidence. Conclusion The evidence suggests that manual and exercise therapy may reduce headache intensity, frequency and disability at short and long-term in people living with cervicogenic headache, but the overall RoB in most included trials was high. However, a sensitivity meta-analysis on low-RoB trials showed moderate-quality evidence supporting the use of spinal manipulation compared to sham interventions. More high-quality trials are necessary to make stronger recommendations, ideally based on methodological recommendations that enhance comparability between studies. Trial registration The protocol for this meta-analysis was pre-registered on PROSPERO under the registration number CRD42021249277.

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“…The material here presented is the first part of this protocol (including the results of the following analyses: descriptives and subgroups, trial reporting, degree of similarity between control intervention and treatment, blinding indices); a second article includes the meta-analysis. 81 …”

Section: Methodsmentioning

confidence: 99%

“…In addition, we identify studies that report on blinding effectiveness and control intervention validation studies. In a parallel publication, 81 the potential impact of these control methods on trial results are formally examined.…”

Section: Introductionmentioning

confidence: 99%

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods

Hohenschurz-Schmidt

Draper-Rodi

Vase

et al. 2022

Pain

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Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article II): a meta-analysis relating methods to trial results

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 21 publications

References 91 publications

Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial

Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial

The effectiveness of manual and exercise therapy on headache intensity and frequency among patients with cervicogenic headache: a systematic review and meta-analysis

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods

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