Clinical trial NCT02328703: Reiki for the Management of Neuropathic Pain
Official title: Reiki for the Management of Neuropathic Pain in Service Members With Extremity Trauma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neuropathic Pain
Amputation, Traumatic
Keywords: Reiki
Neuropathic Pain
Military Service Members
Extermity Trauma
Lead sponsor: Fort Belvoir Community Hospital
Sponsor class: FED
Collaborators: name: Defense and Veterans Center for Integrative Pain Management
name: University of Pennsylvania
name: Walter Reed National Military Medical Center
First posted: 2014-12-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Participants will be followed from start of treatment to up to 4 weeks
measure: Neuropathic Pain Scale (NPS)
timeFrame: Participants will be followed from start of treatment to up to 4 weeks
measure: McGill Pain Questionnaire-Short Form (MPQ-SF)
timeFrame: Participants will be followed from start of treatment to up to 4 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Participants will be followed from start of treatment to up to 4 weeks
measure: Patient Global Impression of Improvement Scale (PGI-I)
timeFrame: Participants will be followed from start of treatment to up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Fort Belvoir Community Hospital
name: MeLisa Gantt, PhD
role: PRINCIPAL_INVESTIGATOR
References: