Trial Outcomes & Findings for Effectiveness of Astym Treatment For de Quervain's Tenosynovitis (NCT NCT02442622)

NCT ID: NCT02442622

Last Updated: 2020-10-09

Results Overview

This scale is a single point scale from 0-10. The participant picks one number to represent their pain, where 0 represents no pain and 10 represents worst pain imaginable.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 4.5 months
• Results posted on: 2020-10-09

Participant Flow

Participant milestones

Measure	Occupational Therapy Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis	Occupational Therapy With ASTYM Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
Overall Study STARTED	15	17
Overall Study COMPLETED	12	16
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Occupational Therapy Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis	Occupational Therapy With ASTYM Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Effectiveness of Astym Treatment For de Quervain's Tenosynovitis

Baseline characteristics by cohort

Measure	Occupational Therapy n=15 Participants Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis	Occupational Therapy With ASTYM n=17 Participants Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM	Total n=32 Participants Total of all reporting groups
Age, Continuous	43.85 years STANDARD_DEVIATION 12.57 • n=5 Participants	42.94 years STANDARD_DEVIATION 14.28 • n=7 Participants	43.40 years STANDARD_DEVIATION 13.43 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	12 Participants n=7 Participants	27 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 4.5 months

This scale is a single point scale from 0-10. The participant picks one number to represent their pain, where 0 represents no pain and 10 represents worst pain imaginable.

Outcome measures

Measure	Occupational Therapy n=12 Participants Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis	Occupational Therapy With ASTYM n=16 Participants Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
Numeric Rating Scale for Pain	3.2 score on a scale Standard Deviation 2.5	2.1 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 1.5 months

This is a test to measure dexterity and bimanual abilities in activities of daily living. It includes 12 tasks with participants being scored on their ability, difficulty and pain during the task. Scores on the individual tasks are summed, and the range of the total SODA score is 0-108. A higher score indicates a higher dexterity.

Outcome measures

Measure	Occupational Therapy n=12 Participants Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis	Occupational Therapy With ASTYM n=16 Participants Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
Sequential Occupational Dexterity Assessment (SODA) Score	107.33 score on a scale Standard Deviation 5.6	106.75 score on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: 4.5 months

It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level. QuickDASH Scoring Formula = ([(sum of n responses)/n] -1)(25) where n represents the number of completed items. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).

Outcome measures

Measure	Occupational Therapy n=12 Participants Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis	Occupational Therapy With ASTYM n=16 Participants Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
Quick Dash Score	4.72 score on a scale Standard Deviation 5.60	10.61 score on a scale Standard Deviation 12.05

Adverse Events

Occupational Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Occupational Therapy With ASTYM

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

Steve Vanlew, PhD

NYU Langone Health

Phone: 646-501-7707

Email: Steve.Vanlew@nyulangone.org

Results disclosure agreements

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