| Research Component | Evidence Gap | Future Research Recommendation |
|---|---|---|
| Study Design Methods and Reporting | Evidence on the sustainability of effects was sparse. There was limited information on adherence and need to maximize retention. | Traditional (explanatory) and pragmatic trials with long-term followup and use of methods to enhance recruitment, retention and adherence are needed as are documentation of adherence and studies with sufficient sample size designed to evaluate differential effectiveness and safety of treatments in subpopulations of interest are needed. Consider recommendations from IMMPACT,36 ACTTION,37 NIH Research Standards for Chronic Low Back Pain38 and Federal Pain Research Strategy.39 |
| Patient populations | Information on overlapping chronic pain conditions or psychosocial factors was generally not provided in included trials. There is a lack of evidence related to treatment of chronic pain in pregnant or breastfeeding women and on the extent to which patients with nociplastic pain may respond differently than those with nociceptive pain. | Documentation of coexisting conditions and factors in trials with sufficient sample-size to evaluate the differential impact of conditions and factors is needed. Studies in pregnant and breastfeeding women with chronic pain are needed as is the comparison of treatment effects between patients with nociplastic pain and those with other types of pain. |
| Interventions and comparators | There is a lack of information on optimal techniques, duration and frequency of treatment and lack of evidence comparing interventions to pharmacological agents or other active controls. | Research leading to standardization of techniques and their delivery to be used in future trials and understanding best combinations of interventions is needed. Pragmatic trials may provide valuable information. Trials comparing interventions with pharmacological treatments are needed. |
| Outcomes measures | There is a lack of consistency in types outcomes measures used for function and pain across trials which makes it challenging to compare results across trials. Commonly used VAS or NRS for pain do not capture the impact of pain or allow for accurate classification or evaluation of changes in chronic pain. Common or known harms are not routinely collected. | Standardized protocols for types of outcomes to be assessed (including harms) would facilitate evaluation and comparison across studies. Use of measures that incorporate understanding of pathophysiological mechanisms and address multiple domains of pain is important. Reporting of the proportions of patients achieving a clinically meaningful improvement for measures of pain and function (i.e., responders) as well as outcomes related to change in use of opioids, healthcare utilization and quality of life are needed. Consider recommendations from IMMPACT,36 ACTTION,37 NIH Research Standards for Chronic Low Back Pain38 and Federal Pain Research Strategy.39 |
From: Evidence Summary
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.