Reiki for the Management of Neuropathic Pain

Neuropathic Pain Clinical Trial

— Reiki4Pain  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02328703
• Other study ID #: 375746
• Secondary ID: N12-P10
• Status: Terminated
• Phase: N/A
• First received: December 18, 2014
• Last updated: May 25, 2017
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2017
• Source: Fort Belvoir Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Neuralgia
• Neuropathic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Fort Belvoir Community Hospital	Defense and Veterans Center for Integrative Pain Management, University of Pennsylvania, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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