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Trial record 1 of 1 for:    NCT02328703
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Reiki for the Management of Neuropathic Pain (Reiki4Pain)

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ClinicalTrials.gov Identifier: NCT02328703
Recruitment Status : Terminated (Study closed due to substantial decrease in the desired patient population.)
First Posted : December 31, 2014
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Defense and Veterans Center for Integrative Pain Management
University of Pennsylvania
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
LTC MeLisa Gantt, Fort Belvoir Community Hospital

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Amputation, Traumatic Other: Reiki Therapy Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Reiki for the Management of Neuropathic Pain in Service Members With Extremity Trauma
Study Start Date : May 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Reiki Therapy by a Reiki Master
The Reiki Master will take approximately 30 minutes to perform a hand placement sequence that will allow the direction of energy toward the site of pain.
Other: Reiki Therapy
Reiki is a biofield energy therapy that is based on the idea that there is a universal energy that supports the body's innate healing abilities. A trained Reiki Master uses their hands as a conduit of the energy that goes naturally to any area of the recipient's body where it is needed. This provides a means for life force energy to recharge and rebalance the human energy fields, creating optimal conditions needed by the body's natural healing system.

Placebo Comparator: Sham Reiki Therapy by a Clinician
The Clinician, who has not trained in Reiki, will mimic the same 30 minute hand placement protocol as the Reiki Master.
Other: Reiki Therapy
Reiki is a biofield energy therapy that is based on the idea that there is a universal energy that supports the body's innate healing abilities. A trained Reiki Master uses their hands as a conduit of the energy that goes naturally to any area of the recipient's body where it is needed. This provides a means for life force energy to recharge and rebalance the human energy fields, creating optimal conditions needed by the body's natural healing system.




Primary Outcome Measures :
  1. 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])

  2. 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).

  3. 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.

  4. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Participants will be followed from start of treatment to up to 4 weeks ]
    The PSQI assesses sleep quality and disturbances over a 1-month time interval will be evaluated using the PSQI (Appendix J). Nineteen items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and day time dysfunction. The sum of scores yields one global score.

  5. Patient Global Impression of Improvement Scale (PGI-I) [ Time Frame: Participants will be followed from start of treatment to up to 4 weeks ]
    The PGI-I consists of a 7-point Likert scale with 1 = "very much improved" to 7 = "very much worse" to capture overall changes related to a study medication or intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be Active, Reserve, or National Guard with previous deployment(s) to OIF, OEF, or OND
  • Be age 18 years or older
  • Have ability to read and understand consent forms and study documents
  • Have sustained at least one traumatic combat extremity injury defined as: single or both arm or leg, above or below knee amputation, mangled limb(s)
  • Report, from a major traumatic extremity injury, an average and worst pain level ≥ 5 (numeric rating scale of 0 to 10) for at least one of three days prior to enrollment
  • Be receiving a stable pain medication regimen defined as a regimen that may include multimodal analgesia with opioids, anticonvulsants and/or antidepressants for neuropathic pain in relatively stable doses with no more than a 10 to 20% increase over the past week prior to enrollment
  • Have a cognitive performance evaluation that is consistent with an understanding of the proposed study as assessed by a "teach back" process
  • Be receiving a minimum of two hours of physical therapy per day

Exclusion Criteria:

  • Moderate to severe traumatic brain injury (TBI) as documented on the standardized evaluation completed by TBI Service providers
  • Active moderate to severe psychological distress or psychiatric condition such as active psychosis, suicidal or homicidal ideation as documented, on the standardized psychological evaluation completed by a behavioral health psychiatrist
  • Pregnancy
  • Any medical condition that in the opinion of the participant's health care provider or PI has the potential to interfere with the effects of Reiki treatments
  • Being pre-scheduled for additional surgeries or major painful and activity limiting procedures during the participant's participation in the study
  • Received Reiki therapy treatment within the last three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328703


Locations
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United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Fort Belvoir Community Hospital
Defense and Veterans Center for Integrative Pain Management
University of Pennsylvania
Walter Reed National Military Medical Center
Investigators
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Principal Investigator: MeLisa Gantt, PhD Fort Belvoir Community Hospital

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Responsible Party: LTC MeLisa Gantt, (former) Chief, Research Programs, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier: NCT02328703     History of Changes
Other Study ID Numbers: 375746
N12-P10 ( Other Grant/Funding Number: TriService Nursing Research Program )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by LTC MeLisa Gantt, Fort Belvoir Community Hospital:
Reiki
Neuropathic Pain
Military Service Members
Extermity Trauma

Additional relevant MeSH terms:
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Neuralgia
Amputation, Traumatic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries