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Residual Limb Pain clinical trials

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NCT ID: NCT05460845 Completed - Amputation Clinical Trials

The Pain in Amputees Reduced by Administration of Diet Examination

PARADE
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05392803 Completed - Phantom Limb Pain Clinical Trials

Pulsed Electromagnetic Fields for Post-Amputation Pain

Start date: August 5, 2022
Phase: N/A
Study type: Interventional

Pulsed electromagnetic field therapy is a possible method of pain control involving the application of electromagnetic energy (also termed nonthermal, pulsed, shortwave radiofrequency therapy). Food and Drug Administration-cleared devices have been in clinical use for over 70 years. For decades, available devices consisted of a large signal generator and bulky coil applicator that were not portable and produced significant electromagnetic interference, making them impractical for common use. However, small, lightweight, relatively inexpensive, noninvasive, Food and Drug Administration-cleared devices that function for 30 days are now available to treat acute and chronic pain, decrease inflammation and edema, and hasten wound healing and bone regeneration. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements, only without the limitations of opioids and peripheral nerve blocks. The purpose of this pilot study is to explore the possibility of treating chronic post-amputation pain with nonthermal, pulsed shortwave (radiofrequency) therapy, optimize the study protocol, and estimate the treatment effect in preparation for developing subsequent definitive clinical trials.

NCT ID: NCT01996254 Completed - Phantom Limb Pain Clinical Trials

Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System

Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).