Trial Outcomes & Findings for The Effect of Osteopathic Manual Therapy on Vascular Supply (NCT NCT01020591)

Results Overview

Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day

Results posted on

2017-05-04

Participant Flow

Thirty subjects between the age of 48 and 80 years with radiographic confirmed knee OA were recruited. All data collection took place at the School of Health Sciences Room 658 Bethune building on South park St in Halifax Nova Scotia between January and March of 2010.

Participant milestones

Participant milestones
Measure	Osteopathic Evaluation osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation	Osteopathic Evaluation With Treatment osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Osteopathic Manual Therapy on Vascular Supply

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Osteopathic Evaluation n=15 Participants osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation	Osteopathic Evaluation With Treatment n=15 Participants osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants	7 Participants n=4 Participants	14 Participants n=27 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Age, Continuous	63.73 years STANDARD_DEVIATION 9.63 • n=93 Participants	63.20 years STANDARD_DEVIATION 7.97 • n=4 Participants	63.47 years STANDARD_DEVIATION 8.80 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Region of Enrollment Canada	15 participants n=93 Participants	15 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day

Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels.

Outcome measures

Outcome measures
Measure	Pre Test to the Osteopathic Evaluation n=15 Participants osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation	Pre Test to the Osteopathic Evaluation With Treatment n=15 Participants osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues	Same Day Post Test to Osteopathic Evaluation n=15 Participants osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation	Post Test to Osteopathic Evaluation With Treatment n=15 Participants osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
Resistive Index (RI)	1.30 ratio Standard Deviation 0.07	1.40 ratio Standard Deviation 0.09	1.30 ratio Standard Deviation 0.06	1.35 ratio Standard Deviation 0.08

SECONDARY outcome

Timeframe: Jan 2010 to March 2010

Outcome measures

Outcome data not reported

Adverse Events

Osteopathic Evaluation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Osteopathic Evaluation With Treatment

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

Wendy Jardine

CDHA

Phone: 902 429 6218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place