Neuropathic Pain Clinical Trial
Official title:
Reiki for the Management of Neuropathic Pain in Service Members With Extremity Trauma
This is a prospective, randomized, double-blind, placebo-controlled, repeated measures study with intention-to-treat that involves exposure to Reiki therapy or a placebo control intervention for a total of six treatments, three treatments per week for two weeks, with a 2-week follow-up for the decrease of neuropathic pain in extremity trauma.
Sixty participants will be randomized to either receive three 30-minute standardized
treatments per week for two weeks of Reiki therapy (n=30) or a placebo intervention (n=30).
All participants will complete the same outcome measures (Brief Pain Inventory, Neuropathic
Pain Scale, Patient Global Impression of Improvement Scale, Pittsburgh Quality of Sleep
Scale, and McGill Pain Questionnaire-SF) at established times. Any opioid and other
analgesic requirements will also be collected.
Aim 1: Test the efficacy of a 2-week course of Reiki therapy on pain outcomes (present,
average and worst pain intensity levels and perceptions of pain relief from the Brief Pain
Inventory (BPI) and Patient Global Impression of Improvement-PGI-I) compared to placebo
Reiki interventions in combat-injured service members with major limb trauma experiencing
neuropathic pain.
Aim 2: Examine effects of a 2-week course of Reiki therapy compared to placebo Reiki
interventions on the quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI),
pain interference (BPI), character and quality of pain (Neuropathic Pain Scale and McGill
Pain Questionnaire-Short Form) in combat-injured service members with major limb trauma
experiencing neuropathic pain.
Aim 3: Describe the differences in pattern of responses to Reiki therapy and placebo Reiki
interventions for pain outcomes (pain intensity, perception of relief and PGI-I) based on
neuropathic pain type, pain duration, and the presence or absence of a diagnosis of PTSD.
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