NCT03855254

Brief Summary

This study explores how contextual effects in the fore of positive and negative communication can affect the effect of an osteopathic technique on pain pressure thresholds.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 21, 2019

Last Update Submit

February 24, 2019

Conditions

Positive Communication (Primary)Negative CommunicationControl Condition

Keywords

Contextual effects

Outcome Measures

Primary Outcomes (1)

  • Pain pressure threshold

    This is the degree to which the participant can tolerate pressure induced through an algometer.

    6 months

Study Arms (3)

Positive communication

EXPERIMENTAL
Behavioral: communication type

Control (neutral communication)

NO INTERVENTION

Negative communication

EXPERIMENTAL
Behavioral: communication type

Interventions

communication typeBEHAVIORAL

Positive and negative communication types are the way that the practitioner communicates to the participant about the potential effectiveness of the osteopathic treatment. The control is a neutral communication condition.

Also known as: Positive communication, Negative communication, Control
Negative communicationPositive communication

Eligibility Criteria

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

You may qualify if:

  • Health volunteers with no forms of existing pain.

You may not qualify if:

  • Participants with existing pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea University

Swansea, Wales, SA28PP, United Kingdom

Location

Study Design

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

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 26, 2019

Study Start

September 1, 2018

Primary Completion

December 5, 2018

Study Completion

January 10, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

GB(1)