Author Names
Cook, C., Learman, K., Showalter, C., Kabbaz, V., O’ Halloran, B.
Reviewer Name
Aidan Gallagher, SPT
Reviewer Affiliation(s)
Duke University Doctor of Physical Therapy Division
Paper Abstract
The purpose of this study was to investigate the comparative effectiveness of early use of thrust (TM) and non-thrust manipulation (NTM) in sample of patients with mechanical low back pain (LBP). The randomized controlled trial included patients with mechanically reproducible LBP, ≥age 18-years who were randomized into two treatment groups. The main outcome measures were the Oswestry Disability Index (ODI) and a Numeric Pain Rating Scale (NPRS), with secondary measures of Rate of Recovery, total visits and days in care, and the work subscale of the Fears Avoidance Beliefs Questionnaire work subscale (FABQ-w). A two-way mixed model MANCOVA was used to compare ODI and pain, at baseline, after visit 2, and at discharge and total visits, days in care, and rate of recovery (while controlling for patient expectations and clinical equipoise). A total of 149 subjects completed the trial and received care over an average of 35 days. There were no significant differences between TM and NTM at the second visit follow-up or at discharge with any of the outcomes categories. Personal equipoise was significantly associated with ODI and pain. The findings suggest that there is no difference between early use of TM or NTM, and secondarily, that personal equipoise affects study outcome. Within-groups changes were significant for both groups.
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
2. Was the method of randomization adequate (i.e., use of randomly generated assignment)?
Yes
3. Was the treatment allocation concealed (so that assignments could not be predicted)?
Yes
4. Were study participants and providers blinded to treatment group assignment?
No
5. Were the people assessing the outcomes blinded to the participants’ group assignments?
Yes
6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
Yes
7. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
Yes
8. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
Yes
9. Was there high adherence to the intervention protocols for each treatment group?
Yes
10. Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
No
11. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
Yes
12. 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
13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
Yes
14. 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
There was no significant difference found between early use thrust and non thrust manipulations in pain and disability outcomes.
Key Finding #2
Both thrust and non thrust manipulations as part of a physical therapy plan of care can contribute to successful outcomes with improvements in outcome measures such as the FABQ-w, NPRS, and ODI.
Key Finding #3
No adverse effects were reported from either thrust or non thrust manipulations.
Key Finding #4
There is a source of variability in the study given that the physical therapists are encouraged to treat each patient with their own individualised plan following the second visit. This doesn’t affect differences noted after the second visit, but could influence differences found at discharge.
Please provide your summary of the paper
A group of patients with mechanical low back pain who were all over 18 years of age and had an in-session improvement in pain or ROM during the assessment phase of the clinical evaluation were recruited to the study. The clinicians all had relevant manual therapy experience. The patients were assigned to thrust or non thrust groups using the roll of a die, neither patients or clinicians were blinded. Clinicians selected appropriate thrust or non-thrust techniques to use based on which group the patient was in. All patients had a standard exercise program for the first two visits, but afterwards the clinicians were encouraged to design individualised plans for the patients. Outcome measures used included the FABQ-w, the NPRS, and the ODI which were done at baseline, after two visits, and at discharge, except the FABQ-w which was only done at baseline and after two visits. In conclusion it was found that there was no significant difference between thrust and non-thrust manipulations when used early in the treatment of lower back pain.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
This impacts clinical practice as if significant differences between thrust and non thrust manipulations were not found then they can perhaps be used interchangeably. The clinician could choose one or the other based on which they feel more confident in, which they feel the patient would be more comfortable with, or which one they believe the patient would respond better to- whether that is according to their impairment or psychosocial factors.
