Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care
Sponsor
Parker University (Other)
Overall Status
Completed
CT.gov ID
NCT04134013
Collaborator
(none)
9
1
2
13.4
0.7
Study Details
Study Description
Brief Summary
The nutritional intervention will reduce LBP and cause 10% weight loss.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
Actual Enrollment
:
9 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 onlyParticipants 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
:
Oct 14, 2019
Actual Primary Completion Date
:
Nov 23, 2019
Actual Study Completion Date
:
Nov 26, 2020
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Low back pain evaluation using NPRS [Maximum six weeks of care]
Reduces Low Back Pain
- Weight loss being measured using scale in pounds [Beginning of study and re-evaluation at the end of six weeks.]
Promotes weight loss
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
BMI 25-40, Experiencing LBP (VAS>4, mechanical, chronic), not pregnant
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Katie Pohlman | Plano | Texas | United States | 75025 |
Sponsors and Collaborators
- Parker University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Parker University
ClinicalTrials.gov Identifier:
NCT04134013
Other Study ID Numbers:
- Parker19_04
First Posted:
Oct 21, 2019
Last Update Posted:
Jan 14, 2022
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Parker University
Additional relevant MeSH terms: