Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care

NCT ID: NCT04134013

Last Updated: 2022-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2020-11-26

Brief Summary

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

Detailed Description

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This feasibility study will assess a two-armed low-back pain (LBP) randomized, prospective clinical trial with nutritional offerings provided for one-arm.

Conditions

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Low Back Pain Nutrition Poor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Project manager, participants, and investigator will be blinded to study. The registered dietitian will not be blinded.

Study Groups

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Nutrition and Chiropractic

LBP chiropractic adjustment per protocol and 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)

Group Type EXPERIMENTAL

Combination: Nutrition AND Chiropractic Adjustment

Intervention Type DIETARY_SUPPLEMENT

LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)

Chiropractic Adjustment ONLY

LBP chiropractic adjustment per protocol

Group Type ACTIVE_COMPARATOR

Chiropractic Adjustment: Spinal Manipulation Therapy

Intervention Type OTHER

LBP chiropractic adjustment per protocol

Interventions

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Combination: Nutrition AND Chiropractic Adjustment

LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)

Intervention Type DIETARY_SUPPLEMENT

Chiropractic Adjustment: Spinal Manipulation Therapy

LBP chiropractic adjustment per protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Parker University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Katie Pohlman

Plano, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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Parker19_04

Identifier Type: -

Identifier Source: org_study_id

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