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

NCT02493127 | Completed Results

• 1 other identifier: 2015P000879
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand and Upper Extremity Illness

Outcome Measures

Primary Outcomes (5)

• Pain Catastrophizing Scale (PCS)

  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)

  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

  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

  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

  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

Study Arms (2)

Standard PCS

EXPERIMENTAL

Grip strength measurements and completes standard PCS

Other: Standard PCS; Other: Grip Strength

Positive PCS

EXPERIMENTAL

Grip strength measurements and completes positively adjusted PCS

Other: Grip Strength; Other: Positively Adjusted PCS

Interventions

Standard PCS OTHER

Subject completes the standard version of the PCS Questionnaire

Standard PCS

Grip Strength OTHER

Research Assistant takes Grip Strength Measurements

Positive PCS; Standard PCS

Positively Adjusted PCS OTHER

Subject completes the positively-adjusted version of the PCS Questionnaire

Positive PCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Hand Strength

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Taylor Pong, Research Coordinator
• Organization: Massachusetts General Hospital

tpong1@partners.org

617-726-1569

Study Officials

• David C Ring, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 9, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Locations

US (1)