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

Completed · Not applicable

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02531711

Run by

University of North Carolina, Chapel Hill

People needed

44

Starts

2015-09-01

Expected to finish

2019-12-30

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• MRI-verified lumbosacral radiculopathy associated with herniated disc, spinal stenosis, or post-surgical fibrosis
• Pain reaching to the knee for at least 12 weeks
• Willing to complete daily diary for 20 weeks, as evidenced by completion of ≥12 of the first 14 days
• Possessing a mobile device (smart phone, tablet, laptop) capable of accessing the application and website
• Able to attend dietitian counseling sessions in Chapel Hill, NC
• Under care of a physician for LR
• Able to read and communicate in English

You may not qualify if…

• Psychosis or severe depression, anxiety, substance abuse disorder
• History of specific food allergies that would prevent adherence to study diet
• Aversion to eating fish
• Currently taking fish oil or other supplements that contain fatty acids under investigation
• Pregnancy or anticipated pregnancy
• Active treatment for a major medical illness, such as malignancy, autoimmune, immune deficiency disorder
• History of vasculitis, intracranial mass, clotting disorder (including medication-induced, e.g., warfarin)
• Cognitive dysfunction preventing informed consent
• Pending personal injury litigation, including worker's compensation
• Chronic long-term disability related to lumbosacral injury/symptoms

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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