Neuropathic Pain Clinical Trial
— Reiki4PainOfficial title:
Reiki for the Management of Neuropathic Pain in Service Members With Extremity Trauma
Verified date | May 2017 |
Source | Fort Belvoir Community Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Fort Belvoir Community Hospital | Defense and Veterans Center for Integrative Pain Management, University of Pennsylvania, Walter Reed National Military Medical Center |
United States,
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 |
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