Author Names

Puentedura, E. et al.

Reviewer Name

Miranda Frohlich, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

 

Paper Abstract

Background: A CPR had been proposed to identify patients with neck pain who would likely respond favorably to thoracic spine TJM. Research on validation of that CPR had not been completed when this trial was initiated. In our clinical experience, though many patients with neck pain responded favorably to thoracic spine TJM, they often reported that their symptomatic cervical spine area had not been adequately addressed.

 

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)?
  • Cannot Determine, Not Reported, or Not Applicable
  1. Were study participants and providers blinded to treatment group assignment?
  • No
  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?
  • Yes
  1. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
  • Yes
  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)?
  • Yes
  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?
  • Cannot Determine, Not Reported, or Not Applicable
  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

Patients who were treated with a combination of cervical spine TJM (thrust joint manipulation) and exercises showed significant improvements in pain and disability compared to patients who were treated with thoracic spine TJM and exercises.

Key Finding #2

Findings showed fewer and shorter post-treatment side effects for patients who were treated with a combination of cervical spine TJM and exercise versus thoracic spine TJM and exercise.

Key Finding #3

The clinical prediction rule (CPR) criteria for the success of thoracic spine TJM combined with exercise for the treatment of patients with neck pain, may actually be a more useful tool in identifying patients who would benefit from cervical spine TJM and exercise.

 

Please provide your summary of the paper

This study was performed to assess if patients who met the CPR criteria for the success of thoracic spine thrust joint manipulation (TJM) for the treatment of neck pain would have a different/improved outcome if they were treated with a cervical spine TJM.  This study consisted of 2 treatment groups for which all patients were randomly assigned, with a primary complaint of neck pain, and meeting 4 out of 6 CPR criteria for thoracic TJM . The thoracic spine group was treated with thoracic TJM and cervical range-of-motion (ROM) exercise. The cervical spine group was treated with cervical TJM and the same cervical range-of-motion (ROM) exercises. A standardized exercise program was given to both groups after the first 2 sessions for the following 3 sessions. There were several methods used to compare changes in pain and function, including the Neck Disability Index (NDI), numeric pain rating scale (NPRS), and Fear-Avoidance Beliefs Questionnaire – physical activity and work (FABQ-PA and FABQ-W). These outcome measures are reliable and were collected at week 1, week 4, and 6 months.  It can be strongly suggested from the results of this study that patients with neck pain of less than 30 days, who meet 4 out of 6 CPR criteria for thoracic spine TJM, may demonstrate better outcomes and benefit more from cervical than thoracic TJM. Furthermore, patients receiving cervical TJM presented with fewer transient post treatment side-effects (neck pain, headache, fatigue).   There are important limitations concerning the results of this study including: small sample size (24 participants), generalization of acute neck pain (neck pain for less than 30 days), recruitment from 1 of 2 clinics in Las Vegas, use of Bonferroni correction, and all interventions provided by 1 physical therapist. Future testing with appropriate sample sizes, more diversity, and an increased number of practitioners will be needed to better apply these findings to the neck pain population as a whole.

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

I believe the study was conducted diligently and with good intention to better a clinical prediction rule (CPR) that’s validity has recently been questioned. I find the results of this study to be very enlightening and hope future studies are conducted for better application in clinical practice.