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Chiropractic Management of Chronic Lower Back Pain in Older Adults

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ClinicalTrials.gov Identifier: NCT00475787
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Low Back Pain
Interventions Procedure: Spinal Manipulation
Procedure: Detuned Ultrasound
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

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.

Detuned Ultrasound

Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Period Title: Overall Study
Started 69 67
Completed 61 60
Not Completed 8 7
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

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.

Detuned Ultrasound

Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Total of all reporting groups
Overall Number of Baseline Participants 69 67 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 67 participants 136 participants
77  (6.8) 77  (6.81) 77  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 67 participants 136 participants
Female
1
   1.4%
1
   1.5%
2
   1.5%
Male
68
  98.6%
66
  98.5%
134
  98.5%
1.Primary Outcome
Title Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)
Hide Description 100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".
Time Frame Baseline, 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Group
Hide Arm/Group Description:

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.

Detuned Ultrasound

Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Overall Number of Participants Analyzed 69 67
Mean (95% Confidence Interval)
Unit of Measure: percentage of change from baseline to 5
26.32
(20.48 to 32.16)
20.45
(14.18 to 26.71)
2.Secondary Outcome
Title Medical Outcome Study Short Form 36(SF-36) Bodily Pain
Hide Description 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.
Time Frame baseline and 5 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

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.

Detuned Ultrasound

Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Overall Number of Participants Analyzed 69 67
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-1.01
(-1.42 to -.6)
-.53
(-.95 to -.11)
3.Secondary Outcome
Title Oswestry Disability Index (ODI)
Hide Description Validated measure of disability associated with lower back pain.
Time Frame baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

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.

Detuned Ultrasound

Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Overall Number of Participants Analyzed 69 67
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
5.45
(2.82 to 8.07)
3.42
(.08 to 6.04)
4.Secondary Outcome
Title Performance of the Timed up and go Test
Hide Description 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.
Time Frame baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

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.

Detuned Ultrasound

Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Overall Number of Participants Analyzed 69 67
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-1.17
(-2.11 to -.23)
-.65
(-1.39 to .09)
5.Secondary Outcome
Title Medical Outcome Study Short Form Physical Functioning Subscale
Hide Description 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.
Time Frame baseline and 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Group
Hide Arm/Group Description:

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.

Detuned Ultrasound

Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Overall Number of Participants Analyzed 69 67
Mean (95% Confidence Interval)
Unit of Measure: percentage of change
-.06
(-.14 to .03)
-.05
(-015 to .04)
Time Frame Adverse event data were collected at each intervention/sham visit and at each of the data collection points (5 weeks, 12 weeks).
Adverse Event Reporting Description 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.
 
Arm/Group Title Spinal Manipulative Therapy Sham Intervention
Hide Arm/Group Description

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.

Detuned Ultrasound
All-Cause Mortality
Spinal Manipulative Therapy Sham Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Spinal Manipulative Therapy Sham Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/69 (7.25%)      1/67 (1.49%)    
Cardiac disorders     
Syncope  [1]  2/69 (2.90%)  2 0/67 (0.00%)  0
myocardial infarction  [2]  0/69 (0.00%)  0 1/67 (1.49%)  1
chest pain  [3]  1/69 (1.45%)  1 0/67 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  [4]  1/69 (1.45%)  1 0/67 (0.00%)  0
Nervous system disorders     
Myelopathy  [5]  1/69 (1.45%)  1 0/67 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Cardiac related syncope, not related to study
[2]
Unrelated MI
[3]
Unrelated chest pain
[4]
Patient fell on ice and injured lower back and neck
[5]
Patient was diagnosed with spondylotic myelopathy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Spinal Manipulative Therapy Sham Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/69 (36.23%)      30/67 (44.78%)    
Musculoskeletal and connective tissue disorders     
Back Pain   25/25 (100.00%)  50 30/67 (44.78%)  40
Joint Pain   9/69 (13.04%)  11 13/67 (19.40%)  18
leg pain   11/69 (15.94%)  18 4/67 (5.97%)  7
Indicates events were collected by systematic assessment
  1. Sham intervention was that it did involve some tactile stimulation
  2. Only VA sites/predominantly male
  3. Clinicians not blinded to invention delivered
  4. All received educational booklet
  5. Consideration of non-specific therapeutic effects
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul Dougherty, DC
Organization: Canandaigua VA Medical Center
Phone: 585-463-2673
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00475787     History of Changes
Other Study ID Numbers: CLIN-011-06F
First Submitted: May 17, 2007
First Posted: May 21, 2007
Results First Submitted: October 21, 2014
Results First Posted: December 30, 2014
Last Update Posted: December 30, 2014