An interventional study of Reiki treatment and chirurgy and Sham treatment and chirurgy in The Lumbar Spine Surgical Intervention, Arthrodesis and Severe Herniated Disc, sponsored by Clinique Bizet. Recruiting at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Clinique Bizet · Not applicable, Interventional, and Supportive care
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:
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:
Researchers will compare Group A (30 patients receiving two Reiki sessions alongside standard care) to Group B (30 patients receiving two Sham/placebo sessions alongside standard 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.
Participant Timeline and Interventions
Both groups will receive routine, standard postoperative care, which includes prescribed analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and standard physical rehabilitation/physiotherapy sessions.
Participants will follow a specific multi-step study process:
Visit 1 (Screening \& Presentation):Meet with the principal investigator to check study eligibility. Patients complete initial SF-12 (quality of life) and VAS (pain) assessments, receive the study information letter/consent form, and are given a 7-day reflection period.
Inclusion \& Randomization:After both the practitioner and patient sign the two copies of the consent form, the patient is randomly assigned in a 1:1 ratio to either Group A (Reiki) or Group B (Sham).
Visit 2 (Pre-Intervention Treatment - 1 Week Before Surgery):Group A: Receives their first Reiki session administered by a certified practitioner with hands positioned above the body in a quiet room.
Group B:Receives their first Sham session administered by a member of the medical staff who simulates the identical hand gestures without delivering energy, maintaining the double-blind setup.
Visit 3 (Intervention):** The scheduled lumbar surgery takes place. Visit 4 (Discharge Visit):The research team provides a recommended postoperative physical rehabilitation program, distributes the daily VAS questionnaire, and evaluates initial analgesic consumption.
Visit 5 (Day 15 Post-Op): Both groups return to the Bizet Clinic for their second designated session (Reiki for Group A; Sham for Group B). Patients complete a scar assessment questionnaire, a VAS pain evaluation, and record their medication intake.
Visit 6 (Day 21 Post-Op):Participants receive a follow-up phone call to record their current VAS pain scores and track analgesic consumption.
Visit 7 (Week 4 Post-Op Follow-Up):Participants undergo a routine radiological exam and a practitioner-led consultation involving a final series of tests: a final VAS pain score, a professional scar assessment, a quality of life questionnaire (SF-12), an analgesic consumption audit, and a patient satisfaction survey using the Clinical Global Impression (CGI) scale.
Note on Safety:Unscheduled visits can be conducted at any stage during the follow-up period if deemed clinically necessary by the surgeon, during which data will be collected directly from the patient's medical record.
83 studies on the registry are indexed under Ankylosis; 18 are open to participants now.
This study's planned enrollment of 60 is below the median of 99 across 34 interventional studies indexed under Ankylosis.
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Exclusion Criteria:
Standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki).
Other: Reiki treatment and chirurgy
standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)
Other: Sham treatment and chirurgy
Patients will receive a Reiki session one week before the intervention. The scheduled intervention will take place.In addition to the study treatments, a recommended postoperative physical rehabilitation program will be suggested to the patients and then they will have their second Reiki session at the Bizet Clinic and complete the scar questionnaire, VAS, and analgesic consumption.
Patients will receive a Sham session one week before the intervention. The scheduled intervention will take place.In addition to the study treatments, a recommended postoperative physical rehabilitation program will be suggested to the patients and then they will have their second Reiki session at the Bizet Clinic and complete the scar questionnaire, VAS, and analgesic consumption.
Change in Pain Intensity
Change in self-reported pain intensity measured using the Visual Analog Scale (VAS). The scale consists of 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate a worse outcome. Unit of Measure: Scale range (0 to 10)
Time frame: 30 days
Clinical Global Impression (CGI) Score
Evaluation of the patient's overall condition assessed by clinicians using the Clinical Global Impression (CGI) scale. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), where higher scores indicate a worse outcome. Unit of Measure: Score on a scale (0 to 7)
Time frame: 30 days
Daily Pain Score via Daily Diary
Daily pain severity reported by the patient in a daily diary using a Visual Analog Scale (VAS) from discharge to 30 days post-intervention. The score ranges from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate a worse outcome. Unit of Measure: Score on a scale (0 to 10)
Time frame: 30 days
Wound Healing Phase Evaluation
Assessment of wound healing progression using the International Visual Wound Color Scale. The scale categorizes the predominant tissue type into discrete stages: Necrosis, Infection, Fibrin, Granulation, and Epithelializing tissue, where progression toward Epithelializing tissue indicates a better outcome. Unit of Measure: Categorical / Nominal stage
Time frame: 30 days
Quality of Life Assessed by SF-12 Questionnaire
Impact of health on everyday life measured using the 12-Item Short Form Health Survey (SF-12). Scores range from 0 to 100, where higher scores indicate a better outcome (better health-related quality of life). (Note: Standard SF-12 uses converted domain scores ranging from 0 to 100 ;but in this study sub-items containing score range from 0 to 5 is used instead). And overall results it score up to 100.
Time frame: 30 days
Daily Antalgic Medication Consumption
Daily consumption of pain medication recorded by the patient in a daily diary from discharge to 30 days post-intervention. Unit of Measure: Milligrams per day (mg/day) (or Pills per day, depending on how you record it)
Time frame: 30 days
Plan to share: Undecided
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