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Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients (D2P3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830596
First Posted: January 28, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Palmer College of Chiropractic
Results First Submitted: April 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Other: HVLA-SM
Other: LVVA-SM
Other: Sham Intervention

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with acute, subacute, or chronic low back pain were recruited from local communities.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HVLA-SM

High velocity, low amplitude lumbo-pelvic manipulation

HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation

LVVA-SM

Low velocity, variable amplitude lumbo-pelvic manipulation

LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation

Sham Intervention

Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks

light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation


Participant Flow:   Overall Study
    HVLA-SM   LVVA-SM   Sham Intervention
STARTED   74   74   73 
COMPLETED   72   72   67 
NOT COMPLETED   2   2   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HVLA-SM

High velocity, low amplitude lumbo-pelvic manipulation

HVLA-SM: High velocity, low amplitude lumbo-pelvic manipulation

LVVA-SM

Low velocity, variable amplitude lumbo-pelvic manipulation

LVVA-SM: Low velocity, variable amplitude lumbo-pelvic manipulation

Sham Intervention

Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks

light effleurage followed by SMT: 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation

Total Total of all reporting groups

Baseline Measures
   HVLA-SM   LVVA-SM   Sham Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 74   74   73   221 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.1  (10.6)   44.5  (10.2)   44.4  (10.5)   44.3  (10.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      34  45.9%      34  45.9%      33  45.2%      101  45.7% 
Male      40  54.1%      40  54.1%      40  54.8%      120  54.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Postural Sway   [ Time Frame: Baseline and 2 weeks ]

2.  Primary:   Postural Sway Speed   [ Time Frame: Baseline and 2 weeks ]

3.  Primary:   Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL   [ Time Frame: Baseline and 2 weeks ]

4.  Primary:   Response to Sudden Load, Peak Muscle Response Per Side   [ Time Frame: Baseline and 2 weeks ]

5.  Primary:   Response to Sudden Load Response Times   [ Time Frame: Baseline and 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Christine Goertz, DC, PhD, Principal Investigator
Organization: Palmer College of Chiropractic
phone: (563) 884-5150
e-mail: christine.goertz@palmer.edu


Publications of Results:
Other Publications:

Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT00830596     History of Changes
Other Study ID Numbers: D2P3
U19AT004137 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2009
First Posted: January 28, 2009
Results First Submitted: April 18, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017