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Reiki for the Management of Neuropathic Pain (Reiki4Pain)

Primary Purpose

Neuropathic Pain, Amputation, Traumatic

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reiki Therapy

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Reiki, Neuropathic Pain, Military Service Members, Extermity Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Walter Reed National Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reiki Therapy by a Reiki Master

Sham Reiki Therapy by a Clinician

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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])

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).

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.

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02328703

First Posted

December 18, 2014

Last Updated

May 25, 2017

Sponsor

Fort Belvoir Community Hospital

Collaborators

Defense and Veterans Center for Integrative Pain Management, University of Pennsylvania, Walter Reed National Military Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02328703

Brief Title

Reiki for the Management of Neuropathic Pain

Acronym

Reiki4Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Study closed due to substantial decrease in the desired patient population.

Study Start Date

May 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fort Belvoir Community Hospital

Collaborators

Defense and Veterans Center for Integrative Pain Management, University of Pennsylvania, Walter Reed National Military Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain, Amputation, Traumatic

Keywords

Reiki, Neuropathic Pain, Military Service Members, Extermity Trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reiki Therapy by a Reiki Master

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham Reiki Therapy by a Clinician

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Reiki Therapy

Intervention Description

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 Measure Information:

Title

Brief Pain Inventory (BPI)

Description

Time Frame