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Recruiting NCT07062146

Evaluation of the Effect of Reiki on Pain After Spinal Fusion

No phase Interventional Chirurgical Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: reiki, Sham (No Treatment).
Who it may be relevant to
Registry conditions: Chirurgical Intervention. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of the Effect of Reiki on Pain After Spinal Fusion: A Comparative, Randomized, Pilot Study

Overview

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

  • Other reiki
    Reiki sessions for 30 minutes, on Day-7 before the surgery and on D15 after the surgery
  • Other Sham (No Treatment)
    Sham sessions for 30 minutes, on D-7 before the surgery and on D15 after the surgery,

Primary outcome measures

  • pain will be assessed at Day 15 using the VAS ( Visial Analog Scale) [Time frame: DAY 15]
Secondary outcome measures (5)
  • Quality of life will be assessed using the SF12 [Time frame: DAY 30]
  • Daily pain intensity will be reported [Time frame: from Day 1 to Day 30]
  • evaluation of patient's overall satisfaction and treatment response [Time frame: at Day 30]
  • Assessment of the condition of the scar at the lumbar level [Time frame: at Day 15 and Day 30]
  • antalgic consumption will be reported [Time frame: from day 1 to day 30]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

France · 1 center
  • Clinique Bizet — Paris

Identifiers

NCT: NCT07062146 · 2024-A02685-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗