Trial Outcomes & Findings for Predicting Patients' Response to Spinal Manipulation (NCT NCT00285649)

NCT ID: NCT00285649

Last Updated: 2017-08-16

Results Overview

The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 192 participants
• Primary outcome timeframe: Mean change from baseline to week 3
• Results posted on: 2017-08-16

Participant Flow

Participants were recruited primarily through direct mail and local media services.

Participant milestones

Measure	HVLA-SM HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation	LVVA-SM LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation	Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
Overall Study STARTED	72	72	48
Overall Study COMPLETED	63	66	42
Overall Study NOT COMPLETED	9	6	6

Reasons for withdrawal

Measure	HVLA-SM HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation	LVVA-SM LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation	Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
Overall Study Lost to Follow-up	6	4	4
Overall Study Withdrawal by Subject	3	2	2

Baseline Characteristics

Predicting Patients' Response to Spinal Manipulation

Baseline characteristics by cohort

Measure	HVLA-SM n=72 Participants HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation	LVVA-SM n=72 Participants LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation	Usual Medical Care n=48 Participants Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)	Total n=192 Participants Total of all reporting groups
Age, Continuous	40.5 years STANDARD_DEVIATION 10.0 • n=5 Participants	39.3 years STANDARD_DEVIATION 8.8 • n=7 Participants	40.3 years STANDARD_DEVIATION 9.5 • n=5 Participants	40.0 years STANDARD_DEVIATION 9.4 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	33 Participants n=7 Participants	22 Participants n=5 Participants	89 Participants n=4 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	39 Participants n=7 Participants	26 Participants n=5 Participants	103 Participants n=4 Participants
Race/Ethnicity, Customized Participant Race · White	63 Participants n=5 Participants	63 Participants n=7 Participants	43 Participants n=5 Participants	169 Participants n=4 Participants
Race/Ethnicity, Customized Participant Race · Other	9 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	23 Participants n=4 Participants
Roland-Morris Disability Questionnaire (RMDQ)	9.8 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants	9.5 units on a scale STANDARD_DEVIATION 3.0 • n=7 Participants	9.7 units on a scale STANDARD_DEVIATION 3.0 • n=5 Participants	9.7 units on a scale STANDARD_DEVIATION 3.2 • n=4 Participants

PRIMARY outcome

Timeframe: Mean change from baseline to week 3

The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.

Outcome measures

Measure	HVLA-SM n=72 Participants HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation	LVVA-SM n=72 Participants LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation	Usual Medical Care n=48 Participants Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
Roland Morris Low Back Pain Disability Questionnaire (RMDQ)	4.0 units on a scale Standard Deviation 4.2	3.8 units on a scale Standard Deviation 4.1	1.0 units on a scale Standard Deviation 3.0

Adverse Events

HVLA-SM*

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LVVA-SM*

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Usual Medical Care*

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HVLA-SM* n=72 participants at risk HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation	LVVA-SM* n=72 participants at risk LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation	Usual Medical Care* n=48 participants at risk Usual Medical Care, Active Comparator, advice, exercises and medications Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
Musculoskeletal and connective tissue disorders Low back pain	4.2% 3/72 • From baseline to follow-up at week 3 Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	4.2% 3/72 • From baseline to follow-up at week 3 Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	10.4% 5/48 • From baseline to follow-up at week 3 Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
Musculoskeletal and connective tissue disorders Pain/stiffness in the extremities	0.00% 0/72 • From baseline to follow-up at week 3 Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	1.4% 1/72 • From baseline to follow-up at week 3 Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.	0.00% 0/48 • From baseline to follow-up at week 3 Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures. \*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.

Additional Information

Ting Xia, PhD (Principal Investigator)

Palmer College of Chiropractic

Phone: 563-884-5161

Email: Ting.Xia@palmer.edu

Results disclosure agreements

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