NCT02828501

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

June 22, 2016

Last Update Submit

April 26, 2019

Conditions

Keywords

Pain Threshold

Outcome Measures

Primary Outcomes (1)

  • Pressure-Pain Threshold as assessed by a pressure algometer

    Two minutes

Study Arms (3)

Lumbar manipulation group

EXPERIMENTAL

Spinal Manipulation

Procedure: Spinal Manipulation

Cervical manipulation group

EXPERIMENTAL

Spinal Manipulation

Procedure: Spinal Manipulation

Control group

NO INTERVENTION

This 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.

Cervical manipulation groupLumbar manipulation group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

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