Neuropathic PainReiki4PainNCT02328703
Reiki for the Management of Neuropathic Pain
A study testing Reiki Therapy in people with Neuropathic Pain and Amputation, Traumatic, run by Fort Belvoir Community Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain, Amputation, Traumatic
- What is being tested?
- Reiki Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Reiki for the Management of Neuropathic Pain in Service Members With Extremity Trauma
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.
Read the 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
- Being tested
- Reiki Therapy
- Keywords
- Reiki, Neuropathic Pain, Military Service Members, Extermity Trauma
- Medical subject headings
- Neuralgia, Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reiki Therapy by a Reiki Master | Experimental | 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. Receives: Other: Reiki Therapy |
| Sham Reiki Therapy by a Clinician | Placebo comparator | The Clinician, who has not trained in Reiki, will mimic the same 30 minute hand placement protocol as the Reiki Master. Receives: Other: Reiki Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: Participants will be followed from start of treatment to up to 4 weeks
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).
Measured: Participants will be followed from start of treatment to up to 4 weeks
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.
Measured: Participants will be followed from start of treatment to up to 4 weeks
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.
Measured: Participants will be followed from start of treatment to up to 4 weeks
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
Measured: Participants will be followed from start of treatment to up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startMay 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Study closed due to substantial decrease in the desired patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fort Belvoir Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- Defense and Veterans Center for Integrative Pain Management, University of Pennsylvania, Walter Reed National Military Medical Center
- Responsible party
- Principal investigator, LTC MeLisa Gantt, Fort Belvoir Community Hospital
- Investigators
- MeLisa Gantt, PhD, Principal investigator, Fort Belvoir Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328703
- Sponsor's protocol ID
- 375746
- Other IDs
- N12-P10
- Acronym
- Reiki4Pain
- Status last verified
- May 2017
- First submitted
- 18 Dec 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reiki for the Management of Neuropathic Pain in Service Members With Extremity Trauma
- ClinicalTrials.gov ID
- NCT02328703
- Acronym / sponsor ID
- Reiki4Pain / 375746
- Conditions
- Neuropathic Pain, Amputation, Traumatic
- Keywords
- Reiki, Neuropathic Pain, Military Service Members, Extermity Trauma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to substantial decrease in the desired patient population.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Fort Belvoir Community HospitalUS federal agency
- Collaborators
- Defense and Veterans Center for Integrative Pain Management, University of Pennsylvania, Walter Reed National Military Medical Center
- Study start
- May 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiki Therapy by a Reiki Master | Experimental | Other: Reiki TherapyThe 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. |
| Sham Reiki Therapy by a Clinician | Placebo comparator | Other: Reiki TherapyThe Clinician, who has not trained in Reiki, will mimic the same 30 minute hand placement protocol as the Reiki Master. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki TherapyReiki 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. | Other | Reiki Therapy by a Reiki Master, Sham Reiki Therapy by a Clinician |
Primary outcome
Brief Pain Inventory (BPI)
Time frame: Participants will be followed from start of treatment to up to 4 weeks
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)
Time frame: Participants will be followed from start of treatment to up to 4 weeks
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)
Time frame: Participants will be followed from start of treatment to up to 4 weeks
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)
Time frame: Participants will be followed from start of treatment to up to 4 weeks
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)
Time frame: Participants will be followed from start of treatment to up to 4 weeks
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
Results and safety
The study was stopped early (reason given: Study closed due to substantial decrease in the desired patient population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MeLisa Gantt, PhD principal investigator
Fort Belvoir Community Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki Therapy in people with Neuropathic Pain and Amputation, Traumatic, run by Fort Belvoir Community Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed due to substantial decrease in the desired patient population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) (time frame: Participants will be followed from start of treatment to up to 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.