Back to resultsmeasurINg forceS durInG cHiropractic Treatment (INSIGHT)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexion-Distraction (non-thrust) spinal manipulation
Sponsored by
About this trial
This is an interventional basic science trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Able to demonstrate the necessary abilities (English language, literacy) needed to provide informed consent without the assistance of another person (e.g., a proxy, spouse, family member or other support person)
- Self-reported low back pain (acute, subacute or chronic) at the time of examination and enrollment
Exclusion Criteria:
- Weight > 300lbs
- Spinal Pathology or conditions contraindicating study procedures or compromising participant safety
- Inflammatory arthropathy involving the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
- Spinal fracture in the past 6 months
- Other conditions requiring referral (e.g. self-reporting alcohol/substance dependence or abuse, unstable spinal segments, and cauda equina syndrome)
- Pregnant or planning to become pregnant within the next 5 weeks
- Unable to tolerate study procedures safely
- Altered Mental Capacity
- Sensitivity to adhesives used in the study
- Uncontrolled hypertension
- Co-morbidity requiring simultaneous clinical management that compromises ability to deliver study procedures or assess the participant's heath status or poses as a scheduling burden
- Retention of legal advice or seeking a health-related insurance claim
- Compliance concerns (e.g. scheduling conflicts, moving from the quad city area, unwilling to undergo required study procedures or receive treatment from study doctor(s))
- Quebec Task Force Classification of 10 or 11: (chronic pain syndrome, visceral/infectious source of LBP)
Sites / Locations
- Palmer Center for Chiropractic Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flexion-Distraction spinal manipulation
Arm Description
Participants will receive Flexion-Distraction treatment from a licensed doctor of chiropractic. During the procedure the participant lies prone on a specially designed treatment table. The table is equipped with a movable lower body section, which can be directed by the study doctor to lower the participants legs, move them from side to side, or in a traction motion. Table movements can occur in combination with other motions, depending on the diagnosis and characteristics specific to the participant's condition. During this procedure, the doctor will also touch the lower or upper part of the participants back or neck with their hands to direct treatment toward specific spinal regions.
Outcomes
Primary Outcome Measures
Traction forces
We will measure traction forces delivered to the participant by the clinician during all study visits over a 2-week time period. Traction forces will be summarized descriptively with means and standard deviations. Primary outcomes will compare changes in traction forces between the baseline and final treatment visit at 2 weeks.
Secondary Outcome Measures
Pain Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) will be used to assess the participant's current back pain level and their average back pain levels over the past 24hrs and week. Participants will be asked to rate their level of pain on a 100 millimeter continuum horizontal scale with no pain and worst imaginable pain anchors.
Full Information
NCT ID
NCT02409797
First Posted
March 12, 2015
Last Updated
March 28, 2017
Sponsor
Palmer College of Chiropractic
1. Study Identification
Unique Protocol Identification Number
NCT02409797
Brief Title
measurINg forceS durInG cHiropractic Treatment
Acronym
INSIGHT
Official Title
measurINg forceS durInG cHiropractic Treatment (INSIGHT): A Single-Arm Clinical Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palmer College of Chiropractic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during the delivery of a specific, manually based chiropractic treatment for participants with low back pain.
Detailed Description
Low back pain (LBP) is a well-recognized health problem. One common manual therapy available for the treatment of LBP is spinal manipulation (SM), which can be separated into 2 categories: High-Velocity Low-Amplitude (thrust) and Low-Velocity (non-thrust) SM according to their force-delivery profiles. One commonly utilized non-thrust SM technique is the Flexion-Distraction procedure. Several studies have reported manually applied forces during thrust SM; however, the forces used during non-thrust SM, specifically those used with Flexion-Distraction treatment are still unknown. The results of this pilot study will provide preliminary information on treatment forces and sample size justification for future full-scale trials, while also ascertaining the feasibility of the study protocol and patient recruitment methods for such trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexion-Distraction spinal manipulation
Arm Type
Experimental
Arm Description
Participants will receive Flexion-Distraction treatment from a licensed doctor of chiropractic. During the procedure the participant lies prone on a specially designed treatment table. The table is equipped with a movable lower body section, which can be directed by the study doctor to lower the participants legs, move them from side to side, or in a traction motion. Table movements can occur in combination with other motions, depending on the diagnosis and characteristics specific to the participant's condition. During this procedure, the doctor will also touch the lower or upper part of the participants back or neck with their hands to direct treatment toward specific spinal regions.
Intervention Type
Other
Intervention Name(s)
Flexion-Distraction (non-thrust) spinal manipulation
Intervention Description
Enrolled participants will receive chiropractic care over a 2-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach and treatment frequency based upon a participant's clinical presentation. If provided, treatments will include low-velocity (non-thrust) spinal manipulation using the Flexion-Distraction procedure. Recommendations for exercise, lifestyle modifications, or other therapies may also be provided.
Primary Outcome Measure Information:
Title
Traction forces
Description
We will measure traction forces delivered to the participant by the clinician during all study visits over a 2-week time period. Traction forces will be summarized descriptively with means and standard deviations. Primary outcomes will compare changes in traction forces between the baseline and final treatment visit at 2 weeks.
Time Frame
Baseline and 2 weeks
Secondary Outcome Measure Information:
Title
Pain Visual Analog Scale (VAS)
Description
The Visual Analog Scale (VAS) will be used to assess the participant's current back pain level and their average back pain levels over the past 24hrs and week. Participants will be asked to rate their level of pain on a 100 millimeter continuum horizontal scale with no pain and worst imaginable pain anchors.
Time Frame
Baseline and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to demonstrate the necessary abilities (English language, literacy) needed to provide informed consent without the assistance of another person (e.g., a proxy, spouse, family member or other support person)
Self-reported low back pain (acute, subacute or chronic) at the time of examination and enrollment
Exclusion Criteria:
Weight > 300lbs
Spinal Pathology or conditions contraindicating study procedures or compromising participant safety
Inflammatory arthropathy involving the spine (e.g. Ankylosing spondylitis, Rheumatoid arthritis)
Spinal fracture in the past 6 months
Other conditions requiring referral (e.g. self-reporting alcohol/substance dependence or abuse, unstable spinal segments, and cauda equina syndrome)
Pregnant or planning to become pregnant within the next 5 weeks
Unable to tolerate study procedures safely
Altered Mental Capacity
Sensitivity to adhesives used in the study
Uncontrolled hypertension
Co-morbidity requiring simultaneous clinical management that compromises ability to deliver study procedures or assess the participant's heath status or poses as a scheduling burden
Retention of legal advice or seeking a health-related insurance claim
Compliance concerns (e.g. scheduling conflicts, moving from the quad city area, unwilling to undergo required study procedures or receive treatment from study doctor(s))
Quebec Task Force Classification of 10 or 11: (chronic pain syndrome, visceral/infectious source of LBP)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Vining, DC
Organizational Affiliation
Palmer Center for Chiropractic Research (PCCR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palmer Center for Chiropractic Research
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Feasibility/pilot study
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