NCT05460845: PARADE

The Pain in Amputees Reduced by Administration of Diet Examination

Completed NA Last updated 30 August 2023

What this trial tests

NA trial testing Low-Carbohydrate Diet in Amputation in 28 participants. Completed in 28 August 2023.

Timeline

1 July 2022

Primary endpoint
28 August 2023

28 August 2023

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 July 2022
Primary completion	28 August 2023
Estimated completion	28 August 2023
Sites	1 location across United States

Drugs / interventions tested

• Low-Carbohydrate Diet

Conditions studied

• Amputation — all drugs for Amputation →
• Phantom Limb Pain — all drugs for Phantom Limb Pain →
• Residual Limb Pain — all drugs for Residual Limb Pain →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 65, any sex, with Amputation or Phantom Limb Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.