Hand and Upper Extremity Illness
Conditions
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.
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.
Interventions
OTHERStandard PCS
Subject completes the standard version of the PCS Questionnaire
OTHERGrip Strength
Research Assistant takes Grip Strength Measurements
OTHERPositively Adjusted PCS
Subject completes the positively-adjusted version of the PCS Questionnaire
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale (PCS) | 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. |
| Positive Pain Catastrophizing Scale (PCS) | 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. |
| Difference in Grip Strength Measured With Dynamometer | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| 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 | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Standard PCS | Positive PCS | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 16 | 51 years STANDARD_DEVIATION 16 | 53 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 57 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Grip Strength affected hand Maximum grip strength | 56 pounds STANDARD_DEVIATION 25 | 66 pounds STANDARD_DEVIATION 32 | 60 pounds STANDARD_DEVIATION 29 |
| Grip Strength affected hand Mean grip strength | 52 pounds STANDARD_DEVIATION 24 | 62 pounds STANDARD_DEVIATION 32 | 57 pounds STANDARD_DEVIATION 28 |
| Grip strength of both hands Maximum grip strength | 73 pounds STANDARD_DEVIATION 28 | 81 pounds STANDARD_DEVIATION 33 | 78 pounds STANDARD_DEVIATION 31 |
| Grip strength of both hands Mean grip strength | 59 pounds STANDARD_DEVIATION 23 | 68 pounds STANDARD_DEVIATION 30 | 68 pounds STANDARD_DEVIATION 30 |
| Grip Strength of non-affected hand Maximum grip strength | 72 pounds STANDARD_DEVIATION 30 | 79 pounds STANDARD_DEVIATION 33 | 76 pounds STANDARD_DEVIATION 33 |
| Grip Strength of non-affected hand Mean grip strength | 67 pounds STANDARD_DEVIATION 28 | 75 pounds STANDARD_DEVIATION 32 | 71 pounds STANDARD_DEVIATION 30 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 56 Participants | 55 Participants | 111 Participants |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 35 Participants | 26 Participants | 61 Participants |
| Sex: Female, Male Male | 25 Participants | 34 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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.
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Pain Catastrophizing Scale (PCS) | Difference in Grip Strength Measured With Dynamometer | Mean grip strength | 0.31 pounds | Standard Deviation 5.3 |
| Standard Pain Catastrophizing Scale (PCS) | Difference in Grip Strength Measured With Dynamometer | Maximum grip strength | -0.77 pounds | Standard Deviation 7.2 |
| Positive PCS | Difference in Grip Strength Measured With Dynamometer | Mean grip strength | 2.2 pounds | Standard Deviation 5.1 |
| Positive PCS | Difference in Grip Strength Measured With Dynamometer | Maximum grip strength | 1.8 pounds | Standard Deviation 6.6 |
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.
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Pain Catastrophizing Scale (PCS) | Difference in Grip Strength Measured With Dynamometer | Mean grip strength | 1.3 pounds | Standard Deviation 4.3 |
| Standard Pain Catastrophizing Scale (PCS) | Difference in Grip Strength Measured With Dynamometer | Maximum grip strength | -0.17 pounds | Standard Deviation 5.4 |
| Positive PCS | Difference in Grip Strength Measured With Dynamometer | Mean grip strength | 3.9 pounds | Standard Deviation 6.2 |
| Positive PCS | Difference in Grip Strength Measured With Dynamometer | Maximum grip strength | 4.0 pounds | Standard Deviation 7.3 |
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.
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Pain Catastrophizing Scale (PCS) | Difference in Grip Strength Measured With Dynamometer | Mean grip strength | 0.71 pounds | Standard Deviation 4.1 |
| Standard Pain Catastrophizing Scale (PCS) | Difference in Grip Strength Measured With Dynamometer | Maximum grip strength | -1.2 pounds | Standard Deviation 6.9 |
| Positive PCS | Difference in Grip Strength Measured With Dynamometer | Mean grip strength | 3.1 pounds | Standard Deviation 4.5 |
| Positive PCS | Difference in Grip Strength Measured With Dynamometer | Maximum grip strength | 2.7 pounds | Standard Deviation 6.5 |
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.
Time frame: enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Pain Catastrophizing Scale (PCS) | Pain Catastrophizing Scale (PCS) | 8.2 units on a scale | Standard Deviation 8.7 |
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.
Time frame: enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Pain Catastrophizing Scale (PCS) | Positive Pain Catastrophizing Scale (PCS) | 36.4 units on a scale | Standard Deviation 9.8 |