Evaluation of the Effect of Reiki on Pain After Spinal Fusion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorClinique Bizet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

Neuropathic patient

Presence of neuropathic pain

Diagnosis of fibromyalgia

Received therapeutic touch, polarity therapy, or professional massage therapy in the past four weeks

Trial design

Design model

Parallel

Treatments tested in this trial

  • reiki

    Other intervention

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

  • Sham (No Treatment)

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki)Experimental treatment 1 intervention
Group B: standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
DAY 15

Secondary outcomes

1

Quality of life will be assessed using the SF12

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")

Time frame
DAY 30
2

Daily pain intensity will be reported

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

Time frame
from Day 1 to Day 30
3

evaluation of patient's overall satisfaction and treatment response

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 : 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse

Time frame
at Day 30
4

Assessment of the condition of the scar at the lumbar level

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

Time frame
at Day 15 and Day 30

Other outcomes

Sponsors and contacts

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