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Phantom Limb Pain clinical trials

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NCT ID: NCT05684445 Completed - Phantom Limb Pain Clinical Trials

The Effect of Distant Reiki on Pain and Holistic Well-being

Start date: October 20, 2022
Phase: N/A
Study type: Interventional

Phantom limb pain is a condition characterized by painful sensations in the missing part of the amputated limb, which reduces the quality of life of the individual. It has been reported that approximately 85% of patients undergoing amputation experience phantom limb pain, and chronic pain is the most common symptom in individuals who have undergone limb amputation. These problems negatively affect individuals physically, mentally and socially and lead to deterioration of holistic well-being. This study will be examined the effect of distant reiki on pain and holistic well-being of ındividuals with phantom pain after amputation.

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: NCT05083611 Completed - Phantom Limb Pain Clinical Trials

Graded Motor Imagery in Phantom Limb Pain (GraMI Protocol)

GraMI
Start date: January 15, 2023
Phase: N/A
Study type: Interventional

The International Association for the Study of Pain defines phantom limb pain (PLP) as that pain referred to a part of the body that has been previously removed as if it were still present. It affects between 55-80% of the population who has suffered an amputation, but not in the same frequency and intensity. Graded motor imagery (GMI) is a progressive, physiotherapeutic treatment modality developed to train and reorganize the brain based on three consecutive techniques: laterality recognition, motor imagery, and mirror therapy. The scientific evidence on the implementation of GMI in PLP is scarce, noting that there is no standardized way to use it in this patient profile. Therefore, the need is generated to develop and validate a GMI protocol to address the PLP and test its effectiveness. The study hypothesis is that graded motor imagery is a conservative treatment method based on motor learning, neuroplasticity, and mirror neuron stimulation that may have positive effects in decreasing phantom limb pain in the amputated patient, and as a consequence, decrease the associated psychological factors and improve the quality of life and functionality of the person. A randomized clinical trial will be performed with simple blinding, following the CONSORT guide for this type of study. It will be carried out at the community level with supervision and follow-up by the principal investigator.

NCT ID: NCT04876989 Completed - Neuropathic Pain Clinical Trials

The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block

Start date: July 21, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of ultrasound-guided thoracic paravertebral block (TPVB) when performing sympathetic block for upper limb pain control.

NCT ID: NCT04538417 Completed - Phantom Limb Pain Clinical Trials

C-RFA of Residual Limb Neuroma

Start date: October 27, 2019
Phase: N/A
Study type: Interventional

To assess changes in pain, physical function, and health-related quality of life in patients with post-amputation neuroma-associated residual limb pain after cooled radiofrequency ablation.

NCT ID: NCT04060875 Completed - Clinical trials for Rheumatoid Arthritis

Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain

Start date: September 21, 2017
Phase:
Study type: Observational

The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.

NCT ID: NCT03588793 Completed - Phantom Limb Pain Clinical Trials

Reliability and Validity of Outcome Measures for Phantom Limb Pain

Start date: December 10, 2018
Phase:
Study type: Observational

Phantom limb pain (PLP) is experienced by 60-80% of all people who have had an amputation. This persistent pain condition can impact on independence, activities of daily living and overall quality of life. While there is some research into PLP there is no consensus on appropriate outcome measures and there is (to our knowledge) neither guideline nor literature evidence on the reliability and validity of outcomes measures for this patient group. Such measures are vital to the robust evaluation of any interventions and/or monitoring progression. The aim of the proposed study is to assess the reliability and validity of four self-report questionnaires (Visual Analog Scale (VAS) for pain, Short Form McGill Pain Questionnaire 2 (SFMPQ-2), Trinity Amputation and Prosthetic Evaluation Scale (TAPES), a health-related quality of life measure (EQ-5D-L), a pain diary, a left/right limb judgement task (Implicit Motor Imagery Testing - IMIT) and the two-point discrimination (TPD)test. The data will be collated and statistically analysed to assess how stable each of the measures are over time (intra session reliability) and how each measure co-relates with the others (validity).

NCT ID: NCT03484429 Completed - Chronic Pain Clinical Trials

Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.

NCT ID: NCT03372668 Completed - Phantom Limb Pain Clinical Trials

Massage Therapy for Phantom Limb Pain: Feasibility and Pilot Study

Start date: August 15, 2014
Phase: N/A
Study type: Interventional

Massage therapy is a treatment self-reported by those with phantom limb pain (PLP) as moderately to extremely effective, but no research to date has been specifically designed to examine such efficacy or effectiveness in this regard. The investigators propose that massage therapy can affect PLP by applying treatment to the corresponding intact limb for amputees. Theoretical underpinnings of massage and mirror therapy have guided this study's development to address PLP through the development of a novel massage intervention. The proof-of-concept experimental study examines the feasibility and outcomes of a combined massage and mirror therapy treatment for individuals with lower limb phantom limb pain. Phantom pain severity, intensity, and interference were measured with visual analogue scales (collected twice weekly for the study's duration) and the Brief Pain Index (collected 4 total times across 12 weeks) using a single-subject, withdrawal design with three, 4-week study phases. Intervention consisted of twice weekly, 20-minute treatments for four weeks. Tailored treatments addressed individual phantom pain experience as if occurring on the corresponding, non-removed limb. Participants viewed treatment as though it were being applied to the amputated limb. Specific Aim: Determine the extent to which massage therapy applied in combination with mirror therapy to the intact leg of an amputee addresses PLP severity, intensity, and interference. Hypothesis: massage and mirror treatment session(s) focused on an intact limb will have acute and cumulative benefits (more pronounced and lasting) for PLP severity, intensity, and interference. All study activity to occur on Indiana University's IUPUI campus.