NCT01869140

Brief Summary

To study the immediate effect of spinal manual therapy on pain perception in normal subjects

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 17, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

6 months

First QC Date

May 17, 2013

Last Update Submit

October 4, 2013

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

  • the Pressure pain threshold in KPa/Cm2 will be measure with an Algometer (SOMEDIC)

    the pressure pain threshold will be measure immediately after intervention and every 15 minutes during 1 hour

Study Arms (3)

sham spinal manual therapy

SHAM COMPARATOR

activator set to zero

Device: spinal manual therapy

percussive spinal manual therapy

EXPERIMENTAL

activator set to the maximum force

Device: spinal manual therapy

Firm thoracic spinal manual therapy

EXPERIMENTAL

Firm thoracic manipulation

Device: spinal manual therapy

Interventions

spinal manual therapyDEVICE

spinal manipulation either manual or instrumental (activator)

Also known as: activator
Firm thoracic spinal manual therapypercussive spinal manual therapysham spinal manual therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Students who volunteer from Murdoch University

You may not qualify if:

  • contraindication to spinal manual therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Murdoch University

Perth, Western Australia, Australia

Location

MeSH Terms

Conditions

Back Pain

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, FunctionalOrthodontic AppliancesOrthodonticsDentistryOrthodontic Appliances, Removable

Study Officials

  • yannick audo, PhD student

    Institut Franco Europeen de Chiropratique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD stud

Study Record Dates

First Submitted

May 17, 2013

First Posted

June 5, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

AU(1)