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NCT Number: NCT03173872

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

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.

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Key information

Conditions

Pain, Chronic Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landstuhl Regional Medical Center

Landstuhl, 09018, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has chronic pain (defined as pain that lasts 3 months or more since first onset).
  • 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.
  • Is affiliated with at least one of the 13 installations within the Kaiserslautern Military Community area
  • Is eligible to receive healthcare at Landstuhl Regional Medical Center
  • Is 18 years and older
  • Can read and speak English
  • Is able to commit to 6 treatments (approximately 2-3 weeks)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Reiki Protocol Hand Placement Procedures

Procedure

Ten Reiki hand placement procedures will last 3 minutes each for a total Reiki session lasting 30 minutes long.

Primary outcomes

  1. 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]).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Landstuhl Regional Medical Center

Fed

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2017
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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