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NCT07722117
Evaluation of the Effect of Reiki on Pain After Lumbar Surgery
Conditions: The Lumbar Spine Surgical Intervention, Arthrodesis, Severe Herniated Disc, Scoliosis, the Positive Effect of Energy Therapy on Pain Reduction, Alternative to Reduce Analgesic Dependence
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Clinique Bizet
Location: Benkessou Paris
Summary
The goal of this clinical trial (prospective, comparative, and randomized double-blind study) is to learn if Reiki (a non-pharmacological intervention), when used alongside standard care, can treat and reduce postoperative pain in patients recovering from lumbar surgery (60 participants total, divided into two groups of 30).
The main questions it aims to answer are:
Does Reiki significantly reduce postoperative pain levels at day 15 (measured by a Visual Analog Scale) compared to a Sham (placebo) treatment? Does Reiki improve patient quality of life, enhance scar healing, lower daily analgesic consumption, and increase overall patient satisfaction compared to the Sham treatment?
Researchers will compare Group A (30 patients receiving Reiki sessions alongside usual care) to Group B (30 patients receiving Sham/placebo sessions alongside usual care) to see if the Reiki group experiences lower pain levels, reduced need for painkillers, better healing, and higher overall satisfaction and quality of life.
Participants will:
* Receive standard postoperative care following their lumbar surgery.
* Be randomly assigned to receive either two sessions of actual Reiki therapy or two sessions of a Sham (placebo) treatment.
* Evaluate their daily pain levels using a Visual Analog Scale (EVA).
* Complete follow-up assessments at specific intervals (Day 15, Day 21, and Day 30) to track pain levels, pain medication intake, scar healing (using a colorimetric scale), quality of life (via the SF-12 questionnaire), and overall satisfaction (via the Clinical Global Impression scale).
Eligibility Criteria
Inclusion Criteria:
* Subject aged 18 years or older.
* Referred for a lumbar surgery.
* 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
Source: ClinicalTrials.gov (NCT07722117). StuddyBuddy aggregates publicly available trial information.