Trial Outcomes & Findings for Chiropractic Management of Chronic Lower Back Pain in Older Adults (NCT NCT00475787)

NCT ID: NCT00475787

Last Updated: 2014-12-30

Results Overview

100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 136 participants
• Primary outcome timeframe: Baseline, 5 weeks
• Results posted on: 2014-12-30

Participant Flow

Participant milestones

Measure	Arm 1 Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Arm 2 Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Overall Study STARTED	69	67
Overall Study COMPLETED	61	60
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chiropractic Management of Chronic Lower Back Pain in Older Adults

Baseline characteristics by cohort

Measure	Arm 1 n=69 Participants Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Arm 2 n=67 Participants Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Total n=136 Participants Total of all reporting groups
Age, Continuous	77 years STANDARD_DEVIATION 6.8 • n=5 Participants	77 years STANDARD_DEVIATION 6.81 • n=7 Participants	77 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	66 Participants n=7 Participants	134 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 5 weeks

100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".

Outcome measures

Measure	Spinal Manipulative Therapy n=69 Participants Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Sham Group n=67 Participants Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)	26.32 percentage of change from baseline to 5 Interval 20.48 to 32.16	20.45 percentage of change from baseline to 5 Interval 14.18 to 26.71

SECONDARY outcome

Timeframe: baseline and 5 Weeks

For the Bodily pain subscale, the higher the number the less self-reported pain. The computed SF-36 pain subscale scores range from 2 to 12.

Outcome measures

Measure	Spinal Manipulative Therapy n=69 Participants Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Sham Group n=67 Participants Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Medical Outcome Study Short Form 36(SF-36) Bodily Pain	-1.01 percentage of change Interval -1.42 to -0.6	-.53 percentage of change Interval -0.95 to -0.11

SECONDARY outcome

Timeframe: baseline and 5 weeks

Validated measure of disability associated with lower back pain.

Outcome measures

Measure	Spinal Manipulative Therapy n=69 Participants Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Sham Group n=67 Participants Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Oswestry Disability Index (ODI)	5.45 percentage of change Interval 2.82 to 8.07	3.42 percentage of change Interval 0.08 to 6.04

SECONDARY outcome

Timeframe: baseline and 5 weeks

The Timed Up and Go Test assesses the amount of time it takes an individual to rise from a standard arm chair, walk a distance of 3 meters, and return to the initial position resting against the back of the chair, in this case the measurement was performed utilizing lasers to assess the time to the three meter mark and also the return to sitting in the chair.

Outcome measures

Measure	Spinal Manipulative Therapy n=69 Participants Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Sham Group n=67 Participants Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Performance of the Timed up and go Test	-1.17 percentage of change Interval -2.11 to -0.23	-.65 percentage of change Interval -1.39 to 0.09

SECONDARY outcome

Timeframe: baseline and 5 weeks

For the Physical Functioning subscale, the higher the number the less self-reported limitations in physical function. The computed SF-36 physical function subscale scores range from 2 to 12.

Outcome measures

Measure	Spinal Manipulative Therapy n=69 Participants Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Sham Group n=67 Participants Detuned Ultrasound Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Medical Outcome Study Short Form Physical Functioning Subscale	-.06 percentage of change Interval -0.14 to 0.03	-.05 percentage of change Interval -15.0 to 0.04

Adverse Events

Spinal Manipulative Therapy

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Sham Intervention

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Spinal Manipulative Therapy n=69 participants at risk Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Sham Intervention n=67 participants at risk Detuned Ultrasound
Nervous system disorders Myelopathy	1.4% 1/69 • Number of events 1 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.	0.00% 0/67 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.
Cardiac disorders Syncope	2.9% 2/69 • Number of events 2 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.	0.00% 0/67 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.
Cardiac disorders myocardial infarction	0.00% 0/69 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.	1.5% 1/67 • Number of events 1 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/69 • Number of events 1 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.	0.00% 0/67 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.
Cardiac disorders chest pain	1.4% 1/69 • Number of events 1 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.	0.00% 0/67 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.

Other adverse events

Measure	Spinal Manipulative Therapy n=69 participants at risk Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.	Sham Intervention n=67 participants at risk Detuned Ultrasound
Musculoskeletal and connective tissue disorders Back Pain	100.0% 25/25 • Number of events 50 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.	44.8% 30/67 • Number of events 40 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.
Musculoskeletal and connective tissue disorders Joint Pain	13.0% 9/69 • Number of events 11 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.	19.4% 13/67 • Number of events 18 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.
Musculoskeletal and connective tissue disorders leg pain	15.9% 11/69 • Number of events 18 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.	6.0% 4/67 • Number of events 7 • Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks). Adverse event (AE) and serious adverse event (SAE) data were tracked for each group. An AE was defined as any undesirable medical event with new onset or significant exacerbation during the course of the study, regardless of whether or not it was considered to be related to study treatment.

Additional Information

Paul Dougherty, DC

Canandaigua VA Medical Center

Phone: 585-463-2673

Email: paul.dougherty@va.gov

Results disclosure agreements

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