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Black women for Osteoarthritis

N/A
Waitlist Available
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 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), immediately after the intervention (12 weeks)
Awards & highlights

Study Summary

This trial will study whether a low-carbohydrate diet can help reduce knee pain for African-American women, and whether the diet has a different effect on African-Americans compared to Non-Hispanic Whites.

Eligible Conditions
  • Osteoarthritis of the Knee

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), immediately after the intervention (12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), immediately after the intervention (12 weeks) 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
WOMAC pain change
Secondary outcome measures
BPI pain interference change
PHQ-9 Depression change
RCS pain intensity change
+3 more
Other outcome measures
RCS time to completion change
TBARS change
TUG time to completion change
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: White womenExperimental Treatment1 Intervention
White women aged 65-75 with knee OA
Group II: Black womenExperimental Treatment1 Intervention
Black women aged 65-75 with knee OA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-carbohydrate diet
2007
N/A
~160

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,588 Previous Clinical Trials
2,280,292 Total Patients Enrolled
8 Trials studying Osteoarthritis
44,658 Patients Enrolled for Osteoarthritis
Robert E Sorge, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Osteoarthritis
200 Patients Enrolled for Osteoarthritis

Media Library

Low-carbohydrate diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04343716 — N/A
Osteoarthritis Research Study Groups: Black women, White women
Osteoarthritis Clinical Trial 2023: Low-carbohydrate diet Highlights & Side Effects. Trial Name: NCT04343716 — N/A
Low-carbohydrate diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04343716 — N/A
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04343716 — N/A

Frequently Asked Questions

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

Who is eligible to be involved in this research endeavor?

"This research necessitates a cohort of 20 individuals with arthrosis aged between 65 and 75. Essential criteria include: age range, chronic pain over the last quarter year, and Body Mass Index falling within 25-40 kg/m2."

Answered by AI

Does this research protocol permit the inclusion of participants under 65 years old?

"This medical trial is looking for applicants aged 65 to 75. Out of the 38 studies that are available to those under 18, 657 trials are suitable for senior citizens."

Answered by AI

Is this research project presently looking for participants?

"The information posted on clinicaltrials.gov implies that this medical trial is no longer recruiting patients. The study was first published on October 1st 2020 and the most recent modification occurred on September 28th 2021. However, there are a multitude of other trials actively enrolling participants at present time."

Answered by AI

What is the aim of this investigation?

"The primary outcome evaluated over a Baseline (week 0) to immediately after intervention (12 weeks) period is the WOMAC pain change. Secondary assessments include SF-36 Quality of Life transformation, BPI pain interference alteration, and RCS pain intensity shift."

Answered by AI

Who else is applying?

What state do they live in?
California
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?
3+

Why did patients apply to this trial?

the amount of pain I am in with alternate 3 monthly injections steriod with Lidocaine and Synvisc and meloxican and all the OTC meds.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How often do you have to travel to Birmingham?
PatientReceived 2+ prior treatments
Recent research and studies
Pain MedicineJournal
The Effect of Low-carbohydrate and Low-fat Diets on Pain in Individuals with Knee Osteoarthritis
Strath, Larissa J, Catherine D Jones, Alan Philip George, Shannon L Lukens, Shannon A Morrison, Taraneh Soleymani, Julie L Locher, Barbara A Gower, and Robert E Sorge. 2019. “The Effect of Low-carbohydrate and Low-fat Diets on Pain in Individuals with Knee Osteoarthritis”. Pain Medicine. Oxford University Press (OUP). doi:10.1093/pm/pnz022.
clinicaltrials.govStudy
Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis
Robert Sorge 2020. "Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04343716.
~4 spots leftby Apr 2025
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