Low-Carbohydrate Diet for Amputations

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
Amputations+3 More
Low-Carbohydrate Diet - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Phantom limb pain (PLP) is defined as pain or discomfort in a missing limb following amputation, whereas residual limb pain (RLP) is often experienced as pain at the site of amputation. Unfortunately, PLP can affect as many as 80% of upper- or lower-extremity amputees, with 40-60% also experiencing RLP. There are many theories regarding the mechanisms underlying these types of pain, but effective treatments remain elusive .Amputation of a limb is often accompanied by a traumatic event that can be emotionally devastating. Consequently, studies have reported high levels of depression in this population, up to 80%. Other studies have reported elevated levels of depression (70%), suicidality (30%) and posttraumatic stress disorder (PTSD, 20%) with PTSD being highly correlated with PLP. Thus, it is critical that effective treatments be employed that address, not only the chronic pain, but the comorbid conditions as well. Diet interventions have been utilized as a non-pharmacological method to reduce pain and/or inflammation. We have shown that a low-carbohydrate diet (LCD) reduced pain independent of weight loss. Importantly, we observed a reduction in depressive symptomology and improved quality of life (QOL) following the LCD. Thus, it is reasonable to expect that the LCD may have beneficial effects of pain experience and also on measures of QOL. Phase 1: To characterize the dietary habits, pain severity and psychological well-being of the local amputee population. Hypotheses: We expect that the local population will show high prevalence of phantom limb pain (PLP) and/or residual limb pain (RLP). Self-report of depressive symptomology, poor-quality diet, will coincide with low QOL reports. Phase 2: To assess the feasibility and efficacy of a low-carbohydrate diet (LCD) to reduce pain and increase QOL in amputees. Hypotheses: All participants will complete the 6-week LCD. Compared to baseline, a 6-week LCD will reduce self-reports of pain and depressive symptoms. Overall QOL will improve over 6 weeks with concomitant improved mood and sleep.

Eligible Conditions

  • Amputations
  • Pain
  • Residual Limb Pain

Treatment Effectiveness

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Baseline (week 0), immediately after the intervention (week 6)

Week 6
AAQ change score
BPI Pain Interference Change
BPI Pain Severity Change
CES-D score change
CFS score change
MPFI score change
NEADL change score
NPQ score change
PROMIS-57 domain change
PRS total and subscale score change
PSQI change score
SF-36 overall score change
Weight change

Trial Safety

Trial Design

1 Treatment Group

Phase 2 Intervention
1 of 1
Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Low-Carbohydrate Diet · No Placebo Group · N/A

Phase 2 Intervention
Behavioral
Experimental Group · 1 Intervention: Low-Carbohydrate Diet · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-Carbohydrate Diet
2012
N/A
~970

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 0), immediately after the intervention (week 6)
Closest Location: University of Alabama at Birmingham · Birmingham, AL
Photo of university of alabama at birmingham 1Photo of university of alabama at birmingham 2Photo of university of alabama at birmingham 3
1991First Recorded Clinical Trial
1 TrialsResearching Amputations
1070 CompletedClinical Trials

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,402 Previous Clinical Trials
2,211,013 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.