Psychological Context Effects

Psychological Context Effects of Participant Expectation on Pain Pressure Thresholds Following Cervicothoracic HVLA Thrust Manipulation: A Double Blind, Crossover, Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Control Condition; Positive Communication (Primary); Negative Communication
• Intervention / Treatment: Behavioral: communication type

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Swansea, Wales, United Kingdom, SA28PP
      • Swansea University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Health volunteers with no forms of existing pain.

Exclusion Criteria:

• Participants with existing pain.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive communication	Behavioral: communication type; 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.; Other Names: Control; Positive communication; Negative communication
No Intervention: Control (neutral communication)
Experimental: Negative communication	Behavioral: communication type; 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.; Other Names: Control; Positive communication; Negative communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain pressure threshold	This is the degree to which the participant can tolerate pressure induced through an algometer.	6 months

Collaborators and Investigators

• Sponsor: Swansea University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 5, 2018
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 24, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Contextual effects
• Other Study ID Numbers: SwanseaU1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Participant data may be sheared to other researcher on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No