Trial Outcomes & Findings for The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness (NCT NCT02493127)
NCT ID: NCT02493127
Last Updated: 2017-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
enrollment
Results posted on
2017-04-13
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness
Baseline characteristics by cohort
| Measure |
Standard PCS
n=60 Participants
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
|
Positive PCS
n=60 Participants
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
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 16 • n=5 Participants
|
51 years
STANDARD_DEVIATION 16 • n=7 Participants
|
53 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Grip Strength affected hand
Mean grip strength
|
52 pounds
STANDARD_DEVIATION 24 • n=5 Participants
|
62 pounds
STANDARD_DEVIATION 32 • n=7 Participants
|
57 pounds
STANDARD_DEVIATION 28 • n=5 Participants
|
|
Grip Strength affected hand
Maximum grip strength
|
56 pounds
STANDARD_DEVIATION 25 • n=5 Participants
|
66 pounds
STANDARD_DEVIATION 32 • n=7 Participants
|
60 pounds
STANDARD_DEVIATION 29 • n=5 Participants
|
|
Grip Strength of non-affected hand
Mean grip strength
|
67 pounds
STANDARD_DEVIATION 28 • n=5 Participants
|
75 pounds
STANDARD_DEVIATION 32 • n=7 Participants
|
71 pounds
STANDARD_DEVIATION 30 • n=5 Participants
|
|
Grip Strength of non-affected hand
Maximum grip strength
|
72 pounds
STANDARD_DEVIATION 30 • n=5 Participants
|
79 pounds
STANDARD_DEVIATION 33 • n=7 Participants
|
76 pounds
STANDARD_DEVIATION 33 • n=5 Participants
|
|
Grip strength of both hands
Mean grip strength
|
59 pounds
STANDARD_DEVIATION 23 • n=5 Participants
|
68 pounds
STANDARD_DEVIATION 30 • n=7 Participants
|
68 pounds
STANDARD_DEVIATION 30 • n=5 Participants
|
|
Grip strength of both hands
Maximum grip strength
|
73 pounds
STANDARD_DEVIATION 28 • n=5 Participants
|
81 pounds
STANDARD_DEVIATION 33 • n=7 Participants
|
78 pounds
STANDARD_DEVIATION 31 • n=5 Participants
|
PRIMARY outcome
Timeframe: enrollmentThe 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.
Outcome measures
| Measure |
Standard Pain Catastrophizing Scale (PCS)
n=60 Participants
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
|
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
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
|
8.2 units on a scale
Standard Deviation 8.7
|
—
|
PRIMARY outcome
Timeframe: enrollmentThe 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.
Outcome measures
| Measure |
Standard Pain Catastrophizing Scale (PCS)
n=60 Participants
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
|
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
|
|---|---|---|
|
Positive Pain Catastrophizing Scale (PCS)
|
36.4 units on a scale
Standard Deviation 9.8
|
—
|
PRIMARY outcome
Timeframe: Day 1Difference 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.
Outcome measures
| Measure |
Standard Pain Catastrophizing Scale (PCS)
n=60 Participants
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
|
Positive PCS
n=60 Participants
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
|
|---|---|---|
|
Difference in Grip Strength Measured With Dynamometer
Mean grip strength
|
0.31 pounds
Standard Deviation 5.3
|
2.2 pounds
Standard Deviation 5.1
|
|
Difference in Grip Strength Measured With Dynamometer
Maximum grip strength
|
-0.77 pounds
Standard Deviation 7.2
|
1.8 pounds
Standard Deviation 6.6
|
PRIMARY outcome
Timeframe: Day 1Difference 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.
Outcome measures
| Measure |
Standard Pain Catastrophizing Scale (PCS)
n=60 Participants
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
|
Positive PCS
n=60 Participants
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
|
|---|---|---|
|
Difference in Grip Strength Measured With Dynamometer
Mean grip strength
|
1.3 pounds
Standard Deviation 4.3
|
3.9 pounds
Standard Deviation 6.2
|
|
Difference in Grip Strength Measured With Dynamometer
Maximum grip strength
|
-0.17 pounds
Standard Deviation 5.4
|
4.0 pounds
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: Day 1Difference 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.
Outcome measures
| Measure |
Standard Pain Catastrophizing Scale (PCS)
n=60 Participants
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
|
Positive PCS
n=60 Participants
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
|
|---|---|---|
|
Difference in Grip Strength Measured With Dynamometer
Mean grip strength
|
0.71 pounds
Standard Deviation 4.1
|
3.1 pounds
Standard Deviation 4.5
|
|
Difference in Grip Strength Measured With Dynamometer
Maximum grip strength
|
-1.2 pounds
Standard Deviation 6.9
|
2.7 pounds
Standard Deviation 6.5
|
Adverse Events
Standard PCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Positive PCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Taylor Pong, Research Coordinator
Massachusetts General Hospital
Phone: 617-726-1569
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place