Chirurgical Intervention
Conditions
Brief summary
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.
Interventions
OTHERreiki
Reiki sessions for 30 minutes, on Day-7 before the surgery and on D15 after the surgery
OTHERSham (No Treatment)
Sham sessions for 30 minutes, on D-7 before the surgery and on D15 after the surgery,
Sponsors
Clinique Bizet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain will be assessed at Day 15 using the VAS ( Visial Analog Scale) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of life will be assessed using the SF12 | 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") |
| Daily pain intensity will be reported | 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 |
| evaluation of patient's overall satisfaction and treatment response | 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 : 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse |
| Assessment of the condition of the scar at the lumbar level | 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 |
| antalgic consumption will be reported | 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) |
Countries
France
Contacts
CONTACTBouchra BENKESSOU, PM
CONTACTgeorges ABI LAHOUD, Professeur
Outcome results
None listed