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Dietary Interventions for Osteoarthritis Pain (DIRECTPain Trial)

N/A

Recruiting

Led By Robert E Sorge, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), immediately before the intervention (week 3), 3 weeks after initiating the intervention (week 6), immediately after the intervention (week 9)

Awards & highlights

DIRECTPain Trial Summary

This trial will investigate the efficacy of low-carb diets to reduce knee OA pain, with an emphasis on racial differences and interactions with biopsychosocial factors. #OA #RacialDisparities #PainRelief #LCD

Who is the study for?

This trial is for English-speaking adults aged 40-75 with knee osteoarthritis, who self-identify as either Non-Hispanic Black or White, have a BMI of 25-40, eat more than 100g of carbs daily, and experience pain most days. Excluded are those on opioids or certain other meds, with recent weight change, major surgery like knee replacement, severe diseases affecting heart/lungs/digestion/metabolism, extreme exercisers or dieters.Check my eligibility

What is being tested?

The study tests if a low-carbohydrate diet can reduce pain and improve quality of life in people with knee OA compared to the standard USDA diet. It will also look at how race might affect these outcomes by focusing on differences between Non-Hispanic Blacks and Whites.See study design

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects from dietary changes may include digestive discomforts such as constipation or diarrhea due to shifts in fiber intake; fatigue during initial adjustment periods; and possible nutrient deficiencies if not properly managed.

DIRECTPain Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), immediately before the intervention (week 3), 3 weeks after initiating the intervention (week 6), immediately after the intervention (week 9)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), immediately before the intervention (week 3), 3 weeks after initiating the intervention (week 6), immediately after the intervention (week 9)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), immediately before the intervention (week 3), 3 weeks after initiating the intervention (week 6), immediately after the intervention (week 9) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

BPI pain change

TUG pain intensity change

Western Ontario and McMaster Osteoarthritis Index pain change

Secondary outcome measures

BPI pain interference change

PHQ-9 Depression change

Repeated Chair Stand pain intensity change

+3 more

Other outcome measures

Repeated Chair Stand time to completion change

TBARS change

TUG time to completion change

+2 more

DIRECTPain Trial Design

2Treatment groups

Experimental Treatment

Group I: Non-Hispanic WhiteExperimental Treatment2 Interventions

White adults ages 40-75 with knee OA.

Group II: Non-Hispanic BlackExperimental Treatment2 Interventions

Black adults ages 40-75 with knee OA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low-carbohydrate diet

2007

N/A

~160

USDA Diet

2018

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,154 Total Patients Enrolled

8 Trials studying Osteoarthritis

44,478 Patients Enrolled for Osteoarthritis

Robert E Sorge, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

1 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Osteoarthritis

20 Patients Enrolled for Osteoarthritis

Media Library

Low-carbohydrate diet Clinical Trial Eligibility Overview. Trial Name: NCT05785884 — N/A

Osteoarthritis Clinical Trial 2023: Low-carbohydrate diet Highlights & Side Effects. Trial Name: NCT05785884 — N/A

Low-carbohydrate diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05785884 — N/A

Osteoarthritis Research Study Groups: Non-Hispanic Black, Non-Hispanic White

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being invited to participate in this research trial?

"This clinical trial only allows those between 40 and 75 years old to participate due to eligibility requirements."

Answered by AI

Who are the ideal candidates for this research endeavor?

"In order to take part in this medical experiment, the patient must be diagnosed with osteoarthritis and between 40-75 years old. Additionally, approximately 200 people are being admitted into this trial."

Answered by AI

How many participants are actively engaged in this trial?

"Affirmative. As per the information on clinicaltrials.gov, this medical study is actively seeking candidates - having been posted on February 1st 2023 and last updated March 14th 2023. 200 individuals are being recruited from a single site to take part in the trial."

Answered by AI

Is recruitment still open for participants in this trial?

"Per the records on clinicaltrials.gov, enrollment for this research is ongoing; it was initially posted February 1st 2023 and last revised March 14th 2023."

Answered by AI

What goals does this investigation aim to achieve?

"The primary outcome of this clinical study, which will be monitored over a 0-week Baseline, 3-weeks pre-intervention and post-intervention (3 weeks and 9 weeks respectively), is the alteration in WOMAC pain. Secondary outcomes include TS pain intensity change (determined by varying ratings on a 0 - 100 scale prior to/after Temporal Summation task) , WOMAC physical function (assessed using 17 questions graded between 0 – 4 with higher scores representing increased impairment in functioning) and RCS pain intensity change (evaluated through contrasts in ratings from 0 -100 before/after Repeated Chair Stand"

Answered by AI

Who else is applying?

What site did they apply to?

University of Alabama at Birmingham

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

Yes give me a call as soon as possible Maurice Henderson 205-709-0754. I suffer daily with OsteoArthritis and OsteoArthritis of the knee .I would like help with this problem and to be able to help others by way of research.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain

Robert Sorge 2023. "Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05785884.

All > American Chronic Pain > Knee Osteoarthritis