Evaluation of the Effect of Reiki on Pain After Spinal Fusion

Not Applicable

Recruiting

• Conditions: Chirurgical Intervention

• Registration Number: NCT07062146
• Lead Sponsor: Clinique Bizet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-10
• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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")
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)
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

Trial Locations

Locations (1)

Clinique Bizet; 🇫🇷 Paris, France