The Pain in Amputees Reduced by Administration of Diet Examination
Public ClinicalTrials.gov record NCT05460845. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Low-Carbohydrate Diet to Reduce Pain and Increase Quality of Life in Amputees
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05460845
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2022
- Primary completion
- Aug 27, 2023
- Completion
- Aug 27, 2023
- Last update posted
- Aug 29, 2023
2022 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05460845, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 29, 2023 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05460845 live on ClinicalTrials.gov.