Additive Effects of Combined Spinal Manipulations on Pain Pressure Threshold
Additive Effects of Combined Cervical and Lumbar Manipulation on Pain Pressure Threshold in a Single Session
1 other identifier
interventional
57
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedApril 30, 2019
April 1, 2019
11 months
June 22, 2016
April 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pressure-Pain Threshold as assessed by a pressure algometer
Two minutes
Study Arms (3)
Lumbar manipulation group
EXPERIMENTALSpinal Manipulation
Cervical manipulation group
EXPERIMENTALSpinal Manipulation
Control group
NO INTERVENTIONThis group will receive a 2 minute supine rest between measurements
Interventions
A spinal manipulation is a high velocity, low amplitude thrust through a physiological barrier in order to elicit a cavitation.
Eligibility Criteria
You may qualify if:
- To be included in this study, consenting male and female participants must be between the ages of 18 and 60. This age range insures skeletal maturity with a reasonably low prevalence of severe osteoarthritis or osteopenia.
You may not qualify if:
- The presence of any of the following factors will exclude the participant from this study:
- Currently involved in a worker's compensation claim or in personal injury litigation.
- Currently on, or applying for, permanent or temporary disability due to a medical or mental health condition.
- Currently taking prescription analgesics.
- Activity-limiting pain arising from any site other than listed in the specific entry criteria.
- pregnancy or have been pregnant in the last year;
- spinal osteoporosis or osteopenia;
- inflammatory joint disease;
- an infection involving the spine;
- severe arthritis;
- any current (within 5 years) neoplastic condition;
- any history of vertebral fracture with current bony instability or measurable deformity;
- severe lumbar stenosis (defined as an A-P diameter of the thecal sac of less than 5 mm at any level, from mid-sagittal lumbar T2-weighted MRI);
- diagnosis of cervical spinal stenosis
- any abnormalities or compression of the spinal cord, cauda equine, or spinal nerves;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Jordon MK, Beattie PF, D'Urso S, Scriven S. Spinal manipulation does not affect pressure pain thresholds in the absence of neuromodulators: a randomized controlled trial. J Man Manip Ther. 2017 Sep;25(4):172-181. doi: 10.1080/10669817.2016.1230352. Epub 2016 Sep 12.
PMID: 28912629DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Candidate
Study Record Dates
First Submitted
June 22, 2016
First Posted
July 11, 2016
Study Start
March 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 30, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share