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Chronic Lumbosacral Radiculopathy: Impact of an Analgesic Dietary Intervention on Pain & Function

NCT02531711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-10-08

No results posted yet for this study

Summary

The goal of this proposed research is to assess the preliminary efficacy of dietary interventions that change dietary fats in improving clinical outcomes related to lumbar radicular pain. After a two-week baseline, consented participants are randomized to one of two diets. Key foods consistent with the diet are provided for 12 weeks along with extensive dietary counseling and support from the study-provided materials. Participants are encouraged to follow the assigned diet for another 6 weeks without provision of food.

Participants complete questionnaires at baseline, randomization, and after 6 weeks, 12 weeks, and 18 weeks on the diet. They provide blood samples at randomization (2 weeks) and after 12 and 18 weeks on the diet.

Conditions

Interventions

OTHER

Diet A

Experimental analgesic dietary intervention

OTHER

Diet B

Healthy comparator diet

Sponsors & Collaborators

  • North American Spine Society (NASS)

    collaborator UNKNOWN

  • Mayday Fund

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Kevin Carneiro, DO · Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-12-30
Completion
2019-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02531711 on ClinicalTrials.gov