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NCT Number: NCT07062146

Evaluation of the Effect of Reiki on Pain After Spinal Fusion

This study involves patients undergoing lumbar spine surgery (lumbar arthrodesis). It compares the effects of Reiki, an energy-based therapy, with conventional approaches to relieve postoperative pain.

The goal is to determine whether this non-drug method can help reduce pain, limit the use of painkillers, and enhance patient comfort during recovery.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Bizet

Paris, 75016, France

Location status: Recruiting

Location contact

Bouchra BENKESSOU, PM

CONTACT

[email protected]

0764486016

Georges ABI LAHOUD, Principal Investigator

CONTACT

goerges ABI LAHOUD, Pr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - Subject aged 18 years or older;
  • Referred for a lumbar fusion of up to 3 levels.
  • Absence of participation in another clinical study.
  • Subject affiliated with a social security scheme or beneficiary of such a scheme

Exclusion criteria

  • Neuropathic patient
  • Presence of neuropathic pain
  • Diagnosis of fibromyalgia
  • Received therapeutic touch, polarity therapy, or professional massage therapy in the past four weeks
  • Unable to undergo medical follow-up for the study
  • Adult subject protected by law, under guardianship or trusteeship

Treatment and study plan

reiki

Other

Reiki sessions for 30 minutes, on Day-7 before the surgery and on D15 after the surgery

Sham (No Treatment)

Other

Sham sessions for 30 minutes, on D-7 before the surgery and on D15 after the surgery,

Primary outcomes

  1. pain will be assessed at Day 15 using the VAS ( Visial Analog Scale)

    Time frame: DAY 15

    The Visual Analog Scale is a subjective measurement tool commonly used to assess the intensity of pain. It consists of a horizontal 10-centimeter line on which the patient marks a point that reflects their experience.

    Minimum and maximum values:

    0 = complete absence of the symptom

    10 = the most severe imaginable intensity of the symptom

    Score interpretation:

    Higher scores indicate greater symptom intensity

    Lower scores indicate lesser intensity

Secondary outcomes

  1. Quality of life will be assessed using the SF12

    Time frame: DAY 30

    The SF-12 (Short-Form Health Survey) a validated questionnaire designed to assess health-related quality of life across physical and mental domains. It is a shortened version of the SF-36, containing 12 items that cover eight key health dimensions.

    Scoring:

    • Higher scores indicate better health status in each domain
    • Each item uses Likert-type responses ("Excellent" to "Poor", or "All of the time" to "None of the time")
  2. Daily pain intensity will be reported

    Time frame: from Day 1 to Day 30

    This daily diary was designed by the research team to record pain intensity using the Visual Analog Scale (VAS), from the day of discharge up to 30 days post-intervention.

    The Visual Analog Scale is a subjective measurement tool commonly used to assess the intensity of pain. It consists of a horizontal 10-centimeter line on which the patient marks a point that reflects their experience.

    • Minimum and maximum values:

    0 = complete absence of the symptom 10 = the most severe imaginable intensity of the symptom

    • Score interpretation:

    Higher scores indicate greater symptom intensity Lower scores indicate lesser intensity

  3. evaluation of patient's overall satisfaction and treatment response

    Time frame: at Day 30

    the Clinical Global Impression (CGI) is a clinician-rated scale used to assess the global change in a patient's condition following a medical or therapeutic intervention, compared to their state at baseline.

    Evaluated on a 7-point scale :

    • = Very much improved
    • = Much improved
    • = Minimally improved
    • = No change
    • = Minimally worse
    • = Much worse
    • = Very much worse
  4. Assessment of the condition of the scar at the lumbar level

    Time frame: at Day 15 and Day 30

    The International Visual Wound Color Scale (IVWCS) This scale is a visual assessment tool that helps clinicians evaluate wound healing by identifying and interpreting the dominant colors present in the wound bed.

    Each color corresponds to a specific tissue type or healing stage.

    Color Categories and Their Meanings:

    • Red: Indicates healthy granulation tissue, which is essential for wound repair. Suggests active healing and good blood supply Requires protection and monitoring for infection
    • Yellow: Often associated with slough or exudate, which may signal infection or delayed healing.

    Requires cleaning and possibly debridement May indicate microbial presence or inflammation

    • Black: Represents necrotic tissue (dead tissue), often due to poor blood supply.

    Requires urgent medical attention Typically treated with debridement and moist dressings

  5. antalgic consumption will be reported

    Time frame: from day 1 to day 30

    This daily diary was designed by the research team and records the daily consumption of analgesics from the day of discharge to 30 days post-intervention.

    Classification of Analgesics in the Daily Diary Analgesic consumption will be categorized according to the standard analgesic step classification:

    • Step 1: Non-opioid analgesics (paracetamol, NSAIDs)
    • Step 2: Weak opioids (codeine, tramadol)
    • Step 3: Strong opioids (morphine, fentanyl)

Study contacts

Contact information is provided by the study sponsor or research team.

Bouchra BENKESSOU, PM

CONTACT

[email protected]

0033140693525

georges ABI LAHOUD, Professeur

CONTACT

Sponsors and collaborators

Lead sponsor

Clinique Bizet

Other

Registry information

Official study title

Evaluation of the Effect of Reiki on Pain After Spinal Fusion: A Comparative, Randomized, Pilot Study

Acronym: REDAL

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 14, 2025
Registry last updated
Jul 9, 2026

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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