Trial Outcomes & Findings for A Clinical Trial of Splinting for DeQuervain's Tenosynovitis (NCT NCT00438191)

NCT ID: NCT00438191

Last Updated: 2017-06-20

Results Overview

The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.

• Recruitment status: COMPLETED
• Target enrollment: 83 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2017-06-20

Participant Flow

Participant milestones

Measure	As-Desired Splinting Subjects who wear the splint as desired	Full Time Splinting Subjects who wear the splint as much as possible
Overall Study STARTED	43	40
Overall Study COMPLETED	32	26
Overall Study NOT COMPLETED	11	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Trial of Splinting for DeQuervain's Tenosynovitis

Baseline characteristics by cohort

Measure	As-Desired Splinting n=43 Participants Subjects who wear the splint as desired	Full Time Splinting n=40 Participants Subjects who wear the splint as much as possible	Total n=83 Participants Total of all reporting groups
Age, Continuous	49.93 years STANDARD_DEVIATION 14.58 • n=5 Participants	48.74 years STANDARD_DEVIATION 13.90 • n=7 Participants	49.26 years STANDARD_DEVIATION 14.55 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	40 participants n=7 Participants	83 participants n=5 Participants
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	36.5 units on a scale STANDARD_DEVIATION 19.0 • n=5 Participants	33.3 units on a scale STANDARD_DEVIATION 17.8 • n=7 Participants	34.96 units on a scale STANDARD_DEVIATION 18.40 • n=5 Participants
Pain Intensity	5.5 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants	5.8 units on a scale STANDARD_DEVIATION 2.4 • n=7 Participants	5.6 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants
Center for Epidemiologic Studies Depression Scale - Revised (CES-D)	16.3 units on a scale STANDARD_DEVIATION 6.5 • n=5 Participants	16.3 units on a scale STANDARD_DEVIATION 8.7 • n=7 Participants	16.3 units on a scale STANDARD_DEVIATION 7.6 • n=5 Participants
Pain Catastrophizing scale (PCS)	20.9 units on a scale STANDARD_DEVIATION 8.7 • n=5 Participants	17.5 units on a scale STANDARD_DEVIATION 9.5 • n=7 Participants	19.3 units on a scale STANDARD_DEVIATION 9.2 • n=5 Participants
Grip Strength	54.1 percentage of non-affected hand STANDARD_DEVIATION 22.9 • n=5 Participants	58.6 percentage of non-affected hand STANDARD_DEVIATION 18.7 • n=7 Participants	56.3 percentage of non-affected hand STANDARD_DEVIATION 21.0 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.

Outcome measures

Measure	As-Desired Splinting n=32 Participants Subjects who wear the splint as desired	Full Time Splinting n=26 Participants Subjects who wear the splint as much as possible
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire	28 units on a scale Standard Deviation 15	29 units on a scale Standard Deviation 20

SECONDARY outcome

Timeframe: 8 weeks

Grip strength is measured as a percentage of the non-affected or least affected side.

Outcome measures

Measure	As-Desired Splinting n=32 Participants Subjects who wear the splint as desired	Full Time Splinting n=26 Participants Subjects who wear the splint as much as possible
Grip Strength	86 percentage of non-affected hand Standard Deviation 25	87 percentage of non-affected hand Standard Deviation 18

SECONDARY outcome

Timeframe: 8 weeks

Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction

Outcome measures

Measure	As-Desired Splinting n=32 Participants Subjects who wear the splint as desired	Full Time Splinting n=26 Participants Subjects who wear the splint as much as possible
Treatment Satisfaction	6.3 units on a scale Standard Deviation 2.6	6.4 units on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: 8 weeks

Pain intensity was measured using the Numeric Rating Scale, on a scale from 0-10, where 0 is no pain and 10 is the most pain.

Outcome measures

Measure	As-Desired Splinting n=32 Participants Subjects who wear the splint as desired	Full Time Splinting n=26 Participants Subjects who wear the splint as much as possible
Pain Intensity	3.8 units on a scale Standard Deviation 2.0	4.4 units on a scale Standard Deviation 2.9

Adverse Events

As-Desired Splinting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Full Time Splinting

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

Massachusetts General Hospital

Email: tpong1@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place