Clinical Trial: Reiki for the Management of Neuropathic Pain

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Reiki for the Management of Neuropathic Pain in Service Members With Extremity Trauma

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Fort Belvoir Community Hospital

Current Primary Outcome:

  • Brief Pain Inventory (BPI) [ Time Frame: Participants will be followed from start of treatment to up to 4 weeks ]
    The BPI Short Form assesses the time relation sensory component of pain intensity (average over the last week, worst and least, and present pain) using a numeric rating scale (0 [No pain] to 10 [Pain as bad as you can imagine]), percentage of pain relief (0 [No relief] to 100% [Complete relief]), and 7 pain interferences concerning work, activity, mood, enjoyment, sleep, walk and relationships are assessed using 0-10 numeric scales (0 [No interference] to 10 [Complete interference])
  • Neuropathic Pain Scale (NPS) [ Time Frame: Participants will be followed from start of treatment to up to 4 weeks ]
    The NPS assesses two pain domains (intensity and unpleasantness), six qualities (sharp, hot, dull, cold, sensitive, and itchy) and two locations (deep and surface).
  • McGill Pain Questionnaire-Short Form (MPQ-SF) [ Time Frame: Participants will be followed from start of treatment to up to 4 weeks ]
    The MPQ-SF is a brief screening tool for pain and has 3 subscales: Sensory (11 word items), Affective (4 word items), and a composite Evaluative score. Fifteen words represent acute, intermittent and chronic pains, and are scored on a four-point Likert-type scale from 0 = none to 3 = severe. A total score of 45 is possible by summing the Sensory and Affective subscales and scoring them separately.
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Participants will be followed from start of treatment to up to 4 weeks ]
    The PSQI

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Fort Belvoir Community Hospital

    Dates:
    Date Received: December 18, 2014
    Date Started: May 2013
    Date Completion:
    Last Updated: May 25, 2017
    Last Verified: May 2017