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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04134013
Other study ID # Parker19_04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date November 26, 2020

Study information

Verified date June 2021
Source Parker University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date November 26, 2020
Est. primary completion date November 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: BMI 25-40, Experiencing LBP (VAS>4, mechanical, chronic), not pregnant Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Combination: Nutrition AND Chiropractic Adjustment
LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)
Other:
Chiropractic Adjustment: Spinal Manipulation Therapy
LBP chiropractic adjustment per protocol

Locations

Country Name City State
United States Katie Pohlman Plano Texas

Sponsors (1)

Lead Sponsor Collaborator
Parker University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Low back pain evaluation using NPRS Reduces Low Back Pain Maximum six weeks of care
Primary Weight loss being measured using scale in pounds Promotes weight loss Beginning of study and re-evaluation at the end of six weeks.
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