Author Names

Bond, B. M., Kinslow, C. D., Yoder, A. W., & Liu, W.

Reviewer Name

Bonnie Leung

Reviewer Affiliation(s)

Duke University School of Medicine, Physical Therapy Division

 

Paper Abstract

Objectives: The long-term goal of this study is to improve the understanding of the biological mechanisms associated with spinal manipulative therapy (SMT) in low back pain. Methods: This project involved a pilot randomized, blinded clinical trial (ClinicalTrials.gov registration number NCT03078114) of 3-week SMT in chronic nonspecific low back pain (CNSLBP) patients. Researchers recruited 29 participants and randomly assigned them into either a SMT (n = 14) or sham SMT (n = 15) group. Pre- and post intervention, we quantified the effect of SMT on clinical outcomes (Numeric Pain Rating Scale and Oswestry Disability Index) and pressure pain threshold (PPT) at local (lumbar spine), regional (lower extremity), and remote (upper extremity) anatomical sites. Results: We observed a significant main effect for time signifying reduced hypersensitivity (increased PPT) at local (p = .015) and regional (p = .014) locations at 3 weeks. Furthermore, there were significant main effects of time indicating improvements in pain (p < .001) and disability (p = .02) from baseline among all participants regardless of intervention. However, no between-group differences were observed in PPT, clinical pain, or disability between the SMT and sham SMT groups over 3 weeks. Conclusions: After 3 weeks of SMT or sham SMT in CNSLBP patients, we found hypoalgesia at local and remote sites along with improved pain and low back-related disability.

 

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

  1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
  • Yes
  1. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
  • Yes
  1. Was the treatment allocation concealed (so that assignments could not be predicted)?
  • Yes
  1. Were study participants and providers blinded to treatment group assignment?
  • Yes
  1. Were the people assessing the outcomes blinded to the participants’ group assignments?
  • Yes
  1. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
  • Yes
  1. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
  • No
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • No
  1. Was there high adherence to the intervention protocols for each treatment group?
  • Yes
  1. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
  • No
  1. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
  • Yes
  1. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
  • Yes
  1. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
  • Yes
  1. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
  • Yes

 

Key Finding #1

Both SMT and sham SMT had reduced hypersensitivity (increased PPT) at local and regional locations from pre-intervention to 3 weeks.

Key Finding #2

No immediate or 3-week hypoalgesia at a remote testing site—suggesting SMT may not have a widespread hypoalgesic effect on CNSLBP patients.

Key Finding #3

Regardless of intervention, there was an observed mean decrease in low back pain-related disability from baseline.

 

Please provide your summary of the paper

Following a 3-week course of SMT or sham SMT in CNSLBP patients, researchers found hypoalgesia at local and regional sites along with improved pain and low back- related disability. However, both groups (SMT and sham SMT) achieved similar outcomes in terms of PPT and clinical outcomes (NPRS and ODI). Therefore, this study suggests the method of SMT force application may not play a large influence on biological outcomes. However, the results should be interpreted with caution, as researchers acknowledge the sample does not accurately reflect the CNSLBP population. Furthermore, monitoring subjects over a longer period of time (i.e. 6 m/o) may help us discover if SMT produces long-term benefits for individuals experiencing CNSLBP.

Please provide your clinical interpretation of this paper.  Include how this study may impact clinical practice and how the results can be implemented.

The study suggests that within a short-term period (3 weeks), individuals with CNSLBP who receive SMT achieve the same results as those who do not receive it. Therefore, clinicians should conduct more research on the topic to determine if it is clinically necessary (and beneficial) for their respective patient populations. In the future, more longitudinal studies are required to develop hypotheses regarding the long-term effects of SMT for various patient populations.