Trial Outcomes & Findings for Patient Response to Spinal Manipulation

Results Overview

Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits

Results posted on

2017-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	HVLA-SM High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude spinal manipulation
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Response to Spinal Manipulation - Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HVLA-SM n=6 Participants High velocity, low amplitude lumbo-pelvic manipulation HVLA-SM: High velocity, low amplitude spinal manipulation
Region of Enrollment United States	6 participants n=99 Participants
Age, Continuous	53 years STANDARD_DEVIATION 10.5 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Race/Ethnicity, Customized White	5 Participants n=99 Participants
Race/Ethnicity, Customized Other	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits

Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.

Outcome measures

Outcome measures
Measure	Feasibility Outcomes n=6 Participants The feasibility outcomes (Primary outcomes 1 \& 2) for this study include participant recruitment, enrollment, and the duration of the study.
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study # Participants Recruited	19 participants
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study # Participants Consented	9 participants
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study # Participants Enrolled	6 participants
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study # Participants Completed	6 participants

PRIMARY outcome

Timeframe: Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits

Feasibility was measured by the study duration from study launch to collection of final study outcomes. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.

Outcome measures

Outcome measures
Measure	Feasibility Outcomes n=4 months The feasibility outcomes (Primary outcomes 1 \& 2) for this study include participant recruitment, enrollment, and the duration of the study.
Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.	4 months

Adverse Events

HVLA-SM

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

Ting Xia, PhD (Principal Investigator)

Palmer College of Chiropractic

Phone: 563-884-5161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place