The Acceptance of Reiki Therapy as a Complementary and Alternative Option for the Management of Chronic Pain

September 9, 2017 updated by: Dr MeLisa Gantt, Landstuhl Regional Medical Center

For the past few years, the military has been looking for an innovative way to decrease the use of opioids for chronic pain. This has prompted military treatment facilities to begin integrating complementary and/or alternative medicine modalities into their conventional plans of care. Reiki, a bio-field energy therapy, is one such modality. The purpose of this prospective repeated measure study is to: 1) introduce the concept Reiki therapy to military healthcare beneficiaries experiencing chronic pain, 2) assess pain outcome after receiving six treatments of Reiki therapy, and 3) assess participant's impression of Reiki therapy as a possible complementary and/or alternative option for the management of chronic pain.

Thirty military healthcare beneficiaries with the complaint of chronic pain will receive a brief introduction to Reiki therapy followed by six 30-minute Reiki sessions provided by trained Reiki Level 1 Practitioner. Participant's knowledge of Reiki will be assessed using pre and post questionnaires; pain will be assessed using the Brief Pain Inventory, Defense Veterans Pain Rating Scale, DoD (Department of Defense) VA (Veteran's Administration) Pain Supplementary Questionnaire, McGill Pain Questionnaire and pain medication diaries; and participant's impression will be assessed using the Patient Global Impression of Improvement Scale and along with a post study questionnaire. If it is found that Reiki therapy helped in decreasing chronic pain outcomes, this treatment modality may be added to Landstuhl Regional Medical (LRMC) Pain Clinic's pool of complementary and alternative medicine options.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Landstuhl, Germany, 09018
        • Landstuhl Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Has chronic pain (defined as pain that lasts 3 months or more since first onset).
  2. Is receiving a stable pain medication regimen (defined as a regimen that has not increased 10% to 20% in the past week prior to enrollment), if on pain medication.
  3. Is affiliated with at least one of the 13 installations within the Kaiserslautern Military Community area
  4. Is eligible to receive healthcare at Landstuhl Regional Medical Center
  5. Is 18 years and older
  6. Can read and speak English
  7. Is able to commit to 6 treatments (approximately 2-3 weeks)

Exclusion Criteria:

  1. Have had surgery or a painful procedure in the last 30 days or are being scheduled for any surgeries or painful procedures during the duration of the study
  2. Already have a working knowledge (e.g., credentialed Reiki Level I, II or III Practitioner or Reiki Master) of Reiki or have had Reiki therapy in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: One Group Study Arm
One group study arm assesses pre Reiki and post Reiki intervention measures
Procedure: Reiki Protocol Hand Placement Procedures
Ten Reiki hand placement procedures will last 3 minutes each for a total Reiki session lasting 30 minutes long.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Description, Relief and Interference with Daily Life (via Brief Pain Inventory)
Time Frame: From baseline measure to up to 3 weeks
This instrument 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]).
From baseline measure to up to 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensory and Affective Pain Perception (via McGill Pain Questionnaire)
Time Frame: From baseline measure to up to 3 weeks
This instrument 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.
From baseline measure to up to 3 weeks
Current Pain Level (Defense and Veteran Pain Rating Scale)
Time Frame: From baseline measure to up to 3 weeks
A Likert Scale graphic tool to describe one's "current" level of pain. The score ranges from 0 "no pain" to 10 "as bad as it could be nothing else matter". The scale is also colored coated depicting Mild 1-3 (Green), Moderate 4-7 (Yellow) and Severe 8-10 (Red).
From baseline measure to up to 3 weeks
Impression of current pain's affect on sleep, mood and stress (via DoD/VA Pain Supplemental Questionnaire)
Time Frame: From baseline measure to up to 3 weeks
This 4-item Likert Scale instrument is used in conjunction with the Defense and Veteran Pain Rating Scale to measure the biopsychosocial impact of "current" pain level on four areas… activity sleep mood and stress.
From baseline measure to up to 3 weeks
Impression of Improvement (via Patient Global Impression of Improvement Scale Questionnaire) Patient Global Impression of Improvement Scale
Time Frame: At mid-point measure and again at 3 weeks
This instrument 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.
At mid-point measure and again at 3 weeks
Knowledge About Reiki (via Reiki Knowledge Assessment Questionnaire)
Time Frame: From baseline measure to up to 3 weeks
This 5-item questionnaire to measure the participant's knowledge about Reiki. The instrument asks five of the most commonly missed questions regarding Reiki…the definition, history, credentials of practitioner, origin and usage.
From baseline measure to up to 3 weeks
Willingness to inform other about Reiki and to continue treatments (via Reiki Post Study Questionnaire)
Time Frame: At the conclusion of 3 weeks
This 5-item questionnaire assesses the participant's impression of Reiki, their willingness to tell a family member, friend or co-worker about the therapy; and their thought of Reiki being offered a permanent treatment option at their healthcare facility.
At the conclusion of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Landstuhl Regional Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: MeLisa A Gantt, PhD, Gantt Clinical Research Institute LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M-10617

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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