Trial Outcomes & Findings for CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study (NCT NCT00705146)

Results Overview

Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-12-11

Participant Flow

Participants were recruited from 3 outpatient hand therapy departments on Vancouver Island from April 1, 2008 to April 30, 2009.

Participant milestones

Participant milestones
Measure	Hybrid Splint 4 Weeks, 1 Week Washout, Then Comfort Cool Splin Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks	Comfort Cool Splint 4 Weeks, 1 Week Washout, Then Hybrid Splin Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
Overall Study STARTED	32	24
Overall Study COMPLETED	31	23
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Hybrid Splint 4 Weeks, 1 Week Washout, Then Comfort Cool Splin Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks	Comfort Cool Splint 4 Weeks, 1 Week Washout, Then Hybrid Splin Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

CMC (Carpometacarpal) OA (Osteoarthritis) Thumb Splint Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hybrid Then Comfort Cool n=32 Participants Hybrid splint for 4 weeks, 1 wk washout, then Comfort Cool splint for 4 weeks	Comfort Cool Then Hybrid Splint n=24 Participants Comfort Cool splint for 4 weeks, 1 wk washout, then Hybrid splint for 4 weeks	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	11 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	62.84 years STANDARD_DEVIATION 8.48 • n=5 Participants	65.67 years STANDARD_DEVIATION 8.64 • n=7 Participants	64.05 years STANDARD_DEVIATION 8.61 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Canada	32 participants n=5 Participants	24 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Pooled participants from both arms from the phase they wore the hybrid splint, then from the phase they wore the comfort cool splint. Mean change scores are reported.

Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.

Outcome measures

Outcome measures
Measure	Hybrid Splint n=56 Participants Use of the hybrid splint for 4 weeks	Comfort Cool Splint n=56 Participants Use of the comfort cool splint for 4 weeks
Hand Function	5.54 units on a scale Interval 0.8 to 10.28	2.69 units on a scale Interval -1.73 to 7.11

SECONDARY outcome

Timeframe: 4 weeks

Population: Pooled all participants for the phase they wore the hybrid, then comfort cool splints, respectively. Mean change scores are reported

AUSCAN 3.1 pain subscale. Possible score range is 0 to 50. Lower scores indicate less pain. Change scores are reported (baseline to 4 weeks splint wear) for each of the two splints.

Outcome measures

Outcome measures
Measure	Hybrid Splint n=56 Participants Use of the hybrid splint for 4 weeks	Comfort Cool Splint n=56 Participants Use of the comfort cool splint for 4 weeks
Pain	5.69 units on a scale Interval 2.66 to 8.71	2.05 units on a scale Interval -0.53 to 4.63

Adverse Events

Hybrid Then Comfort Cool

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfort Cool Then Hybrid Splint

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

Helia Sillem MScOT

VIHA

Phone: 2507557611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place