Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care

December 28, 2021 updated by: Parker University

Nutrition Plus Chiropractic Care for Low Back Pain: a Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Plano, Texas, United States, 75025
        • Katie Pohlman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low back pain evaluation using NPRS
Time Frame: Maximum six weeks of care
Reduces Low Back Pain
Maximum six weeks of care
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
Beginning of study and re-evaluation at the end of six weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parker University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2019

Primary Completion (Actual)

November 23, 2019

Study Completion (Actual)

November 26, 2020

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Parker19_04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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