Reiki for the Management of Neuropathic Pain

NCT ID: NCT02328703

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-03-31

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.

Conditions

Neuropathic Pain; Amputation, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Reiki Therapy

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Reiki Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Defense and Veterans Center for Integrative Pain Management

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Fort Belvoir Community Hospital

FED

Sponsor Role: lead

Responsible Party

LTC MeLisa Gantt

(former) Chief, Research Programs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MeLisa Gantt, PhD

Role: PRINCIPAL_INVESTIGATOR

Fort Belvoir Community Hospital

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

N12-P10

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

375746

Identifier Type: -

Identifier Source: org_study_id