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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard PCS | Experimental | Grip strength measurements and completes standard PCS |
|
| Positive PCS | Experimental | Grip strength measurements and completes positively adjusted PCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard PCS | Other | Subject completes the standard version of the PCS Questionnaire |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Ring, MD PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard PCS | Grip strength measurements and completes standard PCS Standard PCS: Subject completes the standard version of the PCS Questionnaire Grip Strength: Research Assistant takes Grip Strength Measurements |
| FG001 | Positive PCS | Grip strength measurements and completes positively adjusted PCS Grip Strength: Research Assistant takes Grip Strength Measurements Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard PCS | Grip strength measurements and completes standard PCS Standard PCS: Subject completes the standard version of the PCS Questionnaire Grip Strength: Research Assistant takes Grip Strength Measurements |
| BG001 | Positive PCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | enrollment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard PCS | Grip strength measurements and completes standard PCS Standard PCS: Subject completes the standard version of the PCS Questionnaire Grip Strength: Research Assistant takes Grip Strength Measurements |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taylor Pong, Research Coordinator | Massachusetts General Hospital | 617-726-1569 | tpong1@partners.org |
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| ID | Term |
|---|---|
| D018737 | Hand Strength |
| ID | Term |
|---|---|
| D053580 | Muscle Strength |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Grip Strength |
| Other |
Research Assistant takes Grip Strength Measurements |
|
| Positively Adjusted PCS | Other | Subject completes the positively-adjusted version of the PCS Questionnaire |
|
| Day 1 |
Grip strength measurements and completes positively adjusted PCS Grip Strength: Research Assistant takes Grip Strength Measurements Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Grip Strength affected hand | Three grip strength measurements were recorded with the Dynamometer and the mean and maximum grip strength was calculated and reported. | Mean | Standard Deviation | pounds |
|
| Grip Strength of non-affected hand | Three grip strength measurements were recorded with the Dynamometer and the mean and maximum grip strength was calculated and reported. | Mean | Standard Deviation | pounds |
|
| Grip strength of both hands | Three grip strength measurements were recorded with the Dynamometer and the mean and maximum grip strength was calculated and reported. | Mean | Standard Deviation | pounds |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | enrollment |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | pounds | Day 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | pounds | Day 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | pounds | Day 1 |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Positive PCS | Grip strength measurements and completes positively adjusted PCS Grip Strength: Research Assistant takes Grip Strength Measurements Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire | 0 | 60 | 0 | 60 |
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| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |