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Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134013
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Nutrient Foods
Information provided by (Responsible Party):
Parker University

Brief Summary:
The nutritional intervention will reduce LBP and cause 10% weight loss.

Condition or disease Intervention/treatment Phase
Low Back Pain Nutrition Poor Dietary Supplement: Combination: Nutrition AND Chiropractic Adjustment Other: Chiropractic Adjustment: Spinal Manipulation Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Project manager, participants, and investigator will be blinded to study. The registered dietitian will not be blinded.
Primary Purpose: Treatment
Official Title: Nutrition Plus Chiropractic Care for Low Back Pain: a Randomized Clinical Trial
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutrition and Chiropractic
LBP chiropractic adjustment per protocol and 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)
Dietary Supplement: Combination: Nutrition AND Chiropractic Adjustment
LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)

Active Comparator: Chiropractic Adjustment ONLY
LBP chiropractic adjustment per protocol
Other: Chiropractic Adjustment: Spinal Manipulation Therapy
LBP chiropractic adjustment per protocol




Primary Outcome Measures :
  1. Low back pain evaluation using NPRS [ Time Frame: Maximum six weeks of care ]
    Reduces Low Back Pain

  2. Weight loss being measured using scale in pounds [ Time Frame: Beginning of study and re-evaluation at the end of six weeks. ]
    Promotes weight loss



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

BMI 25-40, Experiencing LBP (VAS>4, mechanical, chronic), not pregnant

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134013


Contacts
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Contact: Destiny Y McElroy, MLS, MS 9724386932 ext 1748 dyerby@parker.edu
Contact: Zak Monier, MS, RD 469-358-3802 zak.monier@nutrientfoods.com

Locations
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United States, Texas
Katie Pohlman Recruiting
Plano, Texas, United States, 75025
Contact: Katie Pohlman       kpohlman@parker.edu   
Contact: Zak Monier    469-358-3802      
Sponsors and Collaborators
Parker University
Nutrient Foods

Additional Information:
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Responsible Party: Parker University
ClinicalTrials.gov Identifier: NCT04134013     History of Changes
Other Study ID Numbers: Parker19_04
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parker University:
Chiropractic manipulation
spinal manipulation therapy
osteopathic manipulation
Additional relevant MeSH terms:
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Malnutrition
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Nutrition Disorders
Nutrients
Growth Substances
Physiological Effects of Drugs