The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness

March 1, 2017 updated by: David C. Ring, MD, Massachusetts General Hospital

Objectives:

To determine the association between priming and measurements of hand function such as grip strength

Primary null hypothesis:

There is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to patients that complete the positively adjusted PCS.

Secondary null hypotheses:

There is no difference in grip strength (last of three attempts) as a percent of the opposite hand between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.

There is no difference in grip strength (best of three attempts) before and after completing the questionnaires between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.

Study Overview

Detailed Description

Priming affects all aspects of human behavior. Prior research by the investigators' group determined that completing a positively phrased version of the pain catastrophizing scale (PCS) primed patients to report less disability on average than completing the standard PCS. The influence of priming can be better understood by determining if it also affects direct measurements of hand function such as grip strength measures.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All English-speaking adult patients visiting the Orthopaedic Hand and Upper Extremity Service

Exclusion Criteria:

  • Unable to complete enrollment forms due to mental status or language problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard PCS
Grip strength measurements and completes standard PCS
Subject completes the standard version of the PCS Questionnaire
Research Assistant takes Grip Strength Measurements
Experimental: Positive PCS
Grip strength measurements and completes positively adjusted PCS
Research Assistant takes Grip Strength Measurements
Subject completes the positively-adjusted version of the PCS Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing Scale (PCS)
Time Frame: enrollment
The pain catastrophizing scale is a 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a lower score indicates less catastrophic thinking about pain.
enrollment
Positive Pain Catastrophizing Scale (PCS)
Time Frame: enrollment
The positive pain catastrophizing scale (PCS) is a positively-phrased 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a higher score indicates less catastrophic thinking about pain.
enrollment
Difference in Grip Strength Measured With Dynamometer
Time Frame: Day 1
Difference in Grip strength of the non-affected hand after completing intervention. Each participant completed the grip strength measurement 3 times on the non-affected hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Day 1
Difference in Grip Strength Measured With Dynamometer
Time Frame: Day 1
Difference in Grip strength of the injured hand after completing intervention. Each participant completed the grip strength measurement 3 times on the injured hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Day 1
Difference in Grip Strength Measured With Dynamometer
Time Frame: Day 1
Difference in Grip strength of both hands after completing intervention. Each participant completed the grip strength measurement 3 times with both hands at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2015P000879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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