Evaluation of the Effect of Reiki on Pain After Spinal Fusion

NCT07062146 | Recruiting

• 1 other identifier: 2024-A02685-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chirurgical Intervention

Outcome Measures

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

  DAY 15

Secondary Outcomes (5)

• Quality of life will be assessed using the SF12

  DAY 30

• Daily pain intensity will be reported

  from Day 1 to Day 30

• evaluation of patient's overall satisfaction and treatment response

  at Day 30

• Assessment of the condition of the scar at the lumbar level

  at Day 15 and Day 30

• antalgic consumption will be reported

  from day 1 to day 30

Study Arms (2)

standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki)

EXPERIMENTAL

treatment with reiki session

Other: reiki

standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)

PLACEBO COMPARATOR

treatment with sham session

Other: Sham (No Treatment)

Interventions

Sham (No Treatment) OTHER

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

standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)

reiki OTHER

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

standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Bizet: lead

Study Sites (1)

Clinique Bizet

Paris, 75016, France

RECRUITING

MeSH Terms

Interventions

Therapeutic Touch; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Central Study Contacts

Bouchra BENKESSOU, PM

CONTACT

0033140693525; b.benkessou@hexagone-sante-paris.fr

georges ABI LAHOUD, Professeur

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 28, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)