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Clinical Trial Summary

Physical therapists frequently use spinal manipulation therapy (SMT) to treat spinal pain. However, the methods by which SMT exerts its effects are not well understood. The aim of this study is to assess potential changes in pain pressure threshold following both a cervical and lumbar spine manipulation in a single treatment session at sites local and diffuse to the site of manipulation application. This study will also attempt to determine if the order of the cervical and lumbar manipulation application impacts pain pressure threshold changes.


Clinical Trial Description

The aim of the proposed study is to add to the literature pertaining to the effects of spinal manipulation on PPT. To date, no studies have assessed whether or not there is an additive effect of multiple manipulations during a single treatment session on PPT. The proposed study will assess potential changes in PPT between baseline measurements, following a single cervical or lumbar manipulation, and after the delivery of second spinal manipulation performed on a different segment. The study design will allow for the investigation of possible additive effects, as well as for the effect of the first manipulation to be assessed independently of the second. Order of delivery of the cervical and lumbar manipulation will be randomized among participants to allow investigators to consider the possibility that the order of the manipulations impacts PPT changes.

Research Questions

1. Is a single spinal manipulation of either the cervical or lumbar spine associated with an immediate increase in pain pressure threshold either locally or diffusely when compared to a no treatment control?

2. What is the effect of a second spinal manipulation at a different segment immediately following the first spinal manipulation on pain pressure threshold?

3. Is there a difference based on the order of which spinal manipulation is administered (cervical first, then lumbar; lumbar first, then cervical) on post-intervention local and diffuse pain pressure threshold?

Overview of Research Design This study will be a cross-sectional, single-blinded randomized control trial. This will be a single session, experimental approach in which participants who meet the inclusion/exclusion criteria will be divided into three groups: treatment group 1, treatment group 2, and control group. Group assignment will be performed using randomized concealed allocation. Participants will undergo pain pressure threshold testing using pressure algometry, followed by a cervical manipulation for treatment group 1 and a lumbar manipulation for treatment group 2. The control group will rest quietly for an allotted amount of time. Upon completion of the first intervention, a second pain pressure threshold assessment will be performed. Treatment group 1 will then receive a lumbar manipulation, while treatment group 2 receives a cervical manipulation. The control group will again rest quietly. Following the second intervention, a final pain pressure threshold assessment will be taken. The primary dependent measures will be 1) current pain intensity as reported by a verbal numeric pain rating scale, 2) self-reported stiffness, and 3) pain pressure threshold measured in Newtons. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02828501
Study type Interventional
Source University of South Carolina
Contact
Status Completed
Phase N/A
Start date March 2015
Completion date February 2016

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