Trial Outcomes & Findings for Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles (NCT NCT03539211)

NCT ID: NCT03539211

Last Updated: 2020-09-07

Results Overview

Musculoskeletal ultrasound measured changes in muscle thickness

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline and 10 minutes post intervention
• Results posted on: 2020-09-07

Participant Flow

Participant milestones

Measure	Rotation Exercises 8 minute program of rotation based exercises Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each	Control Exercises 8 minute program of traditional exercises Control Exercises: The subjects received 7 traditional exercises x 10 reps each
Overall Study STARTED	16	15
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Rotation Exercises n=16 Participants 8 minute program of rotation based exercises Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each	Control Exercises n=15 Participants 8 minute program of traditional exercises Control Exercises: The subjects received 7 traditional exercises x 10 reps each	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants	0 Participants n=15 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=16 Participants	15 Participants n=15 Participants	31 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=16 Participants	0 Participants n=15 Participants	0 Participants n=31 Participants
Age, Continuous	21 years STANDARD_DEVIATION 1.5 • n=16 Participants	20.7 years STANDARD_DEVIATION 1.5 • n=15 Participants	20.8 years STANDARD_DEVIATION 1.7 • n=31 Participants
Sex: Female, Male Female	11 Participants n=16 Participants	10 Participants n=15 Participants	21 Participants n=31 Participants
Sex: Female, Male Male	5 Participants n=16 Participants	5 Participants n=15 Participants	10 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	16 participants n=16 Participants	15 participants n=15 Participants	31 participants n=31 Participants

PRIMARY outcome

Timeframe: Baseline and 10 minutes post intervention

Population: External Oblique

Musculoskeletal ultrasound measured changes in muscle thickness

Outcome measures

Measure	Rotation Exercises n=16 Participants 8 minute program of rotation based exercises Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each	Control Exercises n=15 Participants 8 minute program of traditional exercises Control Exercises: The subjects received 7 traditional exercises x 10 reps each
Changes in Muscle Thickness	.820 centimeters Interval 0.78 to 0.85	.671 centimeters Interval 0.6 to 0.7

SECONDARY outcome

Timeframe: Baseline and 10 minutes post intervention

Population: Anterior Sling

Clinician based assessment of muscle function using the sling screen tool; Kappa coefficients were calculated to examine agreement between the 2 physical therapists that completed the sling screen assessments and to account for chance effects in scoring.

A rating system was used for scoring performance. Min value on the scale is 2 and max value = 5; higher score is a better outcome.

Outcome measures

Measure	Rotation Exercises n=16 Participants 8 minute program of rotation based exercises Rotation Exercises: The subjects received 7 trunk rotation stability exercises x 10 reps each	Control Exercises n=15 Participants 8 minute program of traditional exercises Control Exercises: The subjects received 7 traditional exercises x 10 reps each
Changes in Clinical Muscle Assessment Using the Novel Sling Screen	-2.02 score on a scale Standard Deviation .04	-1.82 score on a scale Standard Deviation .07

Adverse Events

Rotation Exercises

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Exercises

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

Brian Catania

ChristianaCare

Phone: 302-838-4700

Email: bcatania@christianacare.org

Results disclosure agreements

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