The Pain in Amputees Reduced by Administration of Diet Examination

NCT05460845 | Completed

• 1 other identifier: IRB-300008971
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation; Phantom Limb Pain; Residual Limb Pain

Outcome Measures

Primary Outcomes (3)

• BPI Pain Severity Change

  BPI pain severity is an average score out of 10.

  Baseline (week 0), immediately after the intervention (week 6)

• BPI Pain Interference Change

  BPI pain interference is an average score from 9 items out of 10.

  Baseline (week 0), immediately after the intervention (week 6)

• SF-36 overall score change

  The Short Form 36 (SF-36) quality of life score is a 0-150 score with higher scores reflecting poorer quality of life. Scores in each of the 7 sections (general health, limitations, physical health, emotional health, social activities, pain and energy) are summed to provide an overall quality of life score. Change scores will be calculated.

  Baseline (week 0), immediately after the intervention (week 6)

Secondary Outcomes (9)

• NPQ score change

  Baseline (week 0), immediately after the intervention (week 6)

• CES-D score change

  Baseline (week 0), immediately after the intervention (week 6)

• PSQI change score

  Baseline (week 0), immediately after the intervention (week 6)

• NEADL change score

  Baseline (week 0), immediately after the intervention (week 6)

• PROMIS-57 domain change

  Baseline (week 0), immediately after the intervention (week 6)

Other Outcomes (1)

• Weight change

  Baseline (week 0), immediately after the intervention (week 6)

Study Arms (1)

Phase 2 Intervention

EXPERIMENTAL

Low-Carbohydrate Diet

Behavioral: Low-Carbohydrate Diet

Interventions

Low-Carbohydrate Diet BEHAVIORAL

Using a meal delivery service and a list of prepared meals and recipes, foods/meals will be delivered to participants weekly to maintain daily net carbohydrate intake to less than 40 grams.

Also known as: LCD

Phase 2 Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Amputation at least 6 months prior

You may not qualify if:

• Inability to read/understand English
• Active infection at amputation site
• PLP/RLP for at least 6 months (\>4/10 on visual analogue scale)
• Amputation at least 6 months prior
• Inability to read/understand English
• Current infection at amputation site
• Unmedicated diabetes
• Unwillingness to follow prescribed diet
• Recent weight change (\>4 kg in past month)
• Currently on a prescribed diet or consuming less than 100 g of daily carbohydrates
• History of eating disorders or other psychiatric disorders requiring hospitalization within the past 6 months
• Digestive diseases
• Difficulty chewing or swallowing
• Reliance on others for meal preparation
• Uncontrolled cardiovascular or pulmonary disease

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Phantom Limb

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 15, 2022
• Study Start: July 1, 2022
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For 5 years following final data analysis
• Access Criteria: De-identified data can be made available on encrypted servers for researchers whose research plans do not overlap with the aims of the current project. Requests will be assessed by the PI and Co-Is as needed.

Locations

US (1)