Reiki for the Management of Neuropathic Pain

NCT02328703 | Terminated

• 2 other identifiers: 375746N12-P10
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Amputation, Traumatic

Keywords

Reiki; Neuropathic Pain; Military Service Members; Extermity Trauma

Outcome Measures

Primary Outcomes (5)

• Brief Pain Inventory (BPI)

  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 \[Complete interference\])

  Participants will be followed from start of treatment to up to 4 weeks

• Neuropathic Pain Scale (NPS)

  The NPS assesses two pain domains (intensity and unpleasantness), six qualities (sharp, hot, dull, cold, sensitive, and itchy) and two locations (deep and surface).

  Participants will be followed from start of treatment to up to 4 weeks

• McGill Pain Questionnaire-Short Form (MPQ-SF)

  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.

  Participants will be followed from start of treatment to up to 4 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  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.

  Participants will be followed from start of treatment to up to 4 weeks

• Patient Global Impression of Improvement Scale (PGI-I)

  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

  Participants will be followed from start of treatment to up to 4 weeks

Study Arms (2)

Reiki Therapy by a Reiki Master

EXPERIMENTAL

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

Sham Reiki Therapy by a Clinician

PLACEBO COMPARATOR

The Clinician, who has not trained in Reiki, will mimic the same 30 minute hand placement protocol as the Reiki Master.

Other: Reiki Therapy

Interventions

Reiki Therapy OTHER

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.

Reiki Therapy by a Reiki Master; Sham Reiki Therapy by a Clinician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fort Belvoir Community Hospital: lead
• Defense and Veterans Center for Integrative Pain Management: collaborator
• University of Pennsylvania: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Neuralgia; Amputation, Traumatic

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• MeLisa Gantt, PhD

  Fort Belvoir Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: (former) Chief, Research Programs

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 31, 2014
• Study Start: May 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)