Importance: When randomized trials are unavailable or not feasible, observational studies can be used to answer causal questions about the comparative effects of interventions by attempting to emulate a hypothetical pragmatic randomized trial (target trial). Published guidance to aid reporting of these studies is not available.
Objective: To develop consensus based guidance for reporting observational studies performed to estimate causal effects by explicitly emulating a target trial.
Importance: When randomized trials are unavailable or not feasible, observational studies can be used to answer causal questions about the comparative effects of interventions by attempting to emulate a hypothetical pragmatic randomized trial (target trial). Published guidance to aid reporting of these studies is not available.
Objective: To develop consensus-based guidance for reporting observational studies performed to estimate causal effects by explicitly emulating a target trial.
Cochrane Database Syst Rev
August 2025
Rationale: N-methyl-D-aspartate (NMDA) receptor antagonists are a group of medicines classed according to their mechanism of action. Ketamine and other NMDA receptor antagonists are used to treat chronic pain, despite uncertain benefits and harms.
Objectives: To evaluate the benefits and harms of ketamine and other NDMA receptor antagonists compared to placebo, usual care, or other medicines for adults with chronic non-cancer, non-headache pain.
The 0-10 numerical rating scale (NRS) and 0-100 visual analogue scale (VAS) are commonly used to assess pain intensity in low back pain (LBP) trials, but their measurement properties remain unclear. AIMS: We aimed to determine the reliability and measurement error of the NRS and VAS in non-specific LBP. We used a test-retest design with online questionnaire administration.
View Article and Find Full Text PDFBackground And Objectives: The aim of the INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project is to develop a tool to identify problematic RCTs in systematic reviews. In stage 1 of the project, a list of potential trustworthiness checks was created. The checks on this list must be evaluated to determine which should be included in the INSPECT-SR tool.
View Article and Find Full Text PDFThere is increasing recognition of the need for routine measurement and reporting of data that can reveal social factors that contribute to health inequities for people with pain. Prioritising what data to collect and understanding how to collect it can be challenging, and no clear guidance exists. We conducted a 3-round Delphi study to develop consensus on the most important items to include in a minimum dataset of equity-relevant variables.
View Article and Find Full Text PDFCochrane Database Syst Rev
March 2025
Background: Low back pain (LBP) is a significant public health issue due to its high prevalence and associated disability burden. Clinical practice guidelines recommend non-pharmacological/non-surgical interventions for managing pain and function in people with LBP.
Objectives: To provide accessible, high-quality evidence on the effects of non-pharmacological and non-surgical interventions for people with LBP and to highlight areas of remaining uncertainty and gaps in the evidence regarding the effects of these interventions for people with LBP.
Objectives: To investigate the efficacy of non-surgical and non-interventional treatments for adults with low back pain compared with placebo.
Eligibility Criteria: Randomised controlled trials evaluating non-surgical and non-interventional treatments compared with placebo or sham in adults (≥18 years) reporting non-specific low back pain.
Information Sources: MEDLINE, CINAHL, EMBASE, PsychInfo and Cochrane Central Register of Controlled Trials were searched from inception to 14 April 2023.
Cochrane Database Syst Rev
March 2025
Background: Antidepressants are commonly used to treat low back pain and spine-related leg pain. However, their benefits and harms are uncertain. This is an update of a 2008 Cochrane review of antidepressants for non-specific low back pain.
View Article and Find Full Text PDFDisabil Rehabil
September 2025
Purpose: To investigate potential mechanisms of a digital rehabilitation intervention associated with improved mobility among adults undertaking rehabilitation.
Materials And Methods: Causal mediation analysis of the AMOUNT trial (ACTRN12614000936628). Participants were randomised to digitally-enabled rehabilitation (virtual reality video games, activity monitors, and handheld computer devices prescribed by a physiotherapist) and usual care or usual care alone.
Int Rev Neurobiol
November 2024
This chapter aims to explain and evaluate the evidence for psychological, physical and complementary therapies as part of a holistic plan for managing neuropathic pain. Psychological therapies refer to interventions targeting mental health, while physical therapies refer to interventions designed to target movement and functional ability, and complementary therapies are those that attempt to target key mechanisms of change to alter brain and body functioning, or thought processes related to the experience of pain. Each therapeutic modality is discussed to narratively report on the evidence and provide implications for clinicians.
View Article and Find Full Text PDFBraz J Phys Ther
December 2024
Background: Low back pain is a severe global health problem. To face this issue, testing interventions using rigorously performed randomized controlled trials is essential. However, it is unclear if a country's income level is related to the quality of trials conducted.
View Article and Find Full Text PDFIntroduction: The effect of pain education (PE) on pain intensity and function diminishes after a few months in people with chronic low back pain (CLBP). One possible explanation is the return of underlying fears and worries related to the condition.
Objective: To explore topics related to participants' beliefs and feelings that might explain why fears and worries persist after a PE-grounded intervention for CLBP.
Investigating how individual characteristics modify treatment effects can improve understanding, interpretation, and translation of trial findings. The purpose of this secondary analysis was to identify treatment effect modifiers of the MI-NAV trial, a 3 arm, parallel randomized controlled trial which compared motivational interviewing and stratified vocational advice intervention in addition to usual case management (UC), to UC alone. This study included (n = 514) participants with musculoskeletal disorders on sick leave for at least 50% of their contracted work hours for at least 7 consecutive weeks with the Norwegian Labour and Welfare Administration.
View Article and Find Full Text PDFJ Orthop Sports Phys Ther
June 2024
To estimate the difference in confidence to become active despite low back pain in people who were exposed to one of 2 video interventions delivered on social media, compared to no intervention. A proof-of-concept, 3-group randomized controlled trial, in a 1:1:1 ratio. Participants aged 18 years and over, with and without low back pain, were recruited via the social media channel Facebook, to view either a humorous video, a neutral video, or to no intervention.
View Article and Find Full Text PDFComplex regional pain syndrome (CRPS) is a rare pain disorder that usually occurs in a limb after trauma. The features of this disorder include severe pain and sensory, autonomic, motor, and trophic abnormalities. Research from the past decade has offered new insights into CRPS epidemiology, pathophysiology, diagnosis, and treatment.
View Article and Find Full Text PDFTo identify the smallest worthwhile effect (SWE) of exercise therapy for people with non-specific chronic low back pain (CLBP). Discrete choice experiment. The SWE was estimated as the lowest reduction in pain that participants would consider exercising worthwhile, compared to not exercising i.
View Article and Find Full Text PDFObjectives: To investigate the effect of emotion regulation skills-focused (ERSF) interventions to reduce pain intensity and improve psychological outcomes for people with chronic pain and to narratively report on safety and intervention compliance.
Methods: Six databases and four registries were searched for randomized controlled trials (RCTs) up to 29 April 2022. Risk of bias was evaluated using the Cochrane RoB 2.
BMJ Evid Based Med
November 2024