NCT04134013

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2020

Completed
Last Updated

January 14, 2022

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

October 16, 2019

Last Update Submit

December 28, 2021

Conditions

Keywords

Chiropractic manipulationspinal manipulation therapyosteopathic manipulation

Outcome Measures

Primary Outcomes (2)

  • Low back pain evaluation using NPRS

    Reduces Low Back Pain

    Maximum six weeks of care

  • Weight loss being measured using scale in pounds

    Promotes weight loss

    Beginning of study and re-evaluation at the end of six weeks.

Study Arms (2)

Nutrition and Chiropractic

EXPERIMENTAL

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

Dietary Supplement: Combination: Nutrition AND Chiropractic Adjustment

Chiropractic Adjustment ONLY

ACTIVE COMPARATOR

LBP chiropractic adjustment per protocol

Other: Chiropractic Adjustment: Spinal Manipulation Therapy

Interventions

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

Nutrition and Chiropractic

LBP chiropractic adjustment per protocol

Chiropractic Adjustment ONLY

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katie Pohlman

Plano, Texas, 75025, United States

Location

Related Links

MeSH Terms

Conditions

Low Back PainMalnutrition

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Project manager, participants, and investigator will be blinded to study. The registered dietitian will not be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 21, 2019

Study Start

October 14, 2019

Primary Completion

November 23, 2019

Study Completion

November 26, 2020

Last Updated

January 14, 2022

Record last verified: 2021-06

Locations