Back to resultsNutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care
Primary Purpose
Low Back Pain, Nutrition Poor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combination: Nutrition AND Chiropractic Adjustment
Chiropractic Adjustment: Spinal Manipulation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Chiropractic manipulation, spinal manipulation therapy, osteopathic manipulation
Eligibility Criteria
Inclusion Criteria:
BMI 25-40, Experiencing LBP (VAS>4, mechanical, chronic), not pregnant
Exclusion Criteria:
Sites / Locations
- Katie Pohlman
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nutrition and Chiropractic
Chiropractic Adjustment ONLY
Arm Description
LBP chiropractic adjustment per protocol and 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)
LBP chiropractic adjustment per protocol
Outcomes
Primary Outcome Measures
Low back pain evaluation using NPRS
Reduces Low Back Pain
Weight loss being measured using scale in pounds
Promotes weight loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04134013
Brief Title
Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care
Official Title
Nutrition Plus Chiropractic Care for Low Back Pain: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
November 23, 2019 (Actual)
Study Completion Date
November 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parker University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The nutritional intervention will reduce LBP and cause 10% weight loss.
Detailed Description
This feasibility study will assess a two-armed low-back pain (LBP) randomized, prospective clinical trial with nutritional offerings provided for one-arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Nutrition Poor
Keywords
Chiropractic manipulation, spinal manipulation therapy, osteopathic manipulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Project manager, participants, and investigator will be blinded to study. The registered dietitian will not be blinded.
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition and Chiropractic
Arm Type
Experimental
Arm Description
LBP chiropractic adjustment per protocol and 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)
Arm Title
Chiropractic Adjustment ONLY
Arm Type
Active Comparator
Arm Description
LBP chiropractic adjustment per protocol
Intervention Type
Dietary Supplement
Intervention Name(s)
Combination: Nutrition AND Chiropractic Adjustment
Intervention Description
LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)
Intervention Type
Other
Intervention Name(s)
Chiropractic Adjustment: Spinal Manipulation Therapy
Intervention Description
LBP chiropractic adjustment per protocol
Primary Outcome Measure Information:
Title
Low back pain evaluation using NPRS
Description
Reduces Low Back Pain
Time Frame
Maximum six weeks of care
Title
Weight loss being measured using scale in pounds
Description
Promotes weight loss
Time Frame
Beginning of study and re-evaluation at the end of six weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 25-40, Experiencing LBP (VAS>4, mechanical, chronic), not pregnant
Exclusion Criteria:
Facility Information:
Facility Name
Katie Pohlman
City
Plano
State/Province
Texas
ZIP/Postal Code
75025
Country
United States
12. IPD Sharing Statement
Links:
URL
https://nutrientfoods.com/
Description
Nutrient Foods
Learn more about this trial
Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care
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