NCT07722117

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Sep 2025Jun 2028

Study Start

First participant enrolled

September 10, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

July 20, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

scoliosisNSAIDssurgery for lumbar herniated discReikienergy therapythe positive effect of energy therapy on pain reductionalternative to reduce analgesic dependence

Outcome Measures

Primary Outcomes (1)

  • 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)

    30 days

Secondary Outcomes (5)

  • Clinical Global Impression (CGI) Score

    30 days

  • Daily Pain Score via Daily Diary

    30 days

  • Wound Healing Phase Evaluation

    30 days

  • Quality of Life Assessed by SF-12 Questionnaire

    30 days

  • Daily Antalgic Medication Consumption

    30 days

Study Arms (2)

Group A treated with Reiki

EXPERIMENTAL

Standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki).

Other: Reiki treatment and chirurgy

Groupe B control treated with Sham

SHAM COMPARATOR

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

Other: Sham treatment and chirurgy

Interventions

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.

Groupe B control treated with Sham

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.

Group A treated with Reiki

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Benkessou

Paris, 75016, France

RECRUITING

Bizet Clinic

Paris, 75016, France

RECRUITING

Related Publications (8)

  • Guo X, Long Y, Qin Z, Fan Y. Therapeutic effects of Reiki on interventions for anxiety: a meta-analysis. BMC Palliat Care. 2024 Jun 13;23(1):147. doi: 10.1186/s12904-024-01439-x.

    PMID: 38872168BACKGROUND
  • Kocoglu F, Zincir H. The Effect of Reiki on Pain, Fatigue, and Quality of Life in Adolescents With Dysmenorrhea. Holist Nurs Pract. 2021 Nov-Dec 01;35(6):306-314. doi: 10.1097/HNP.0000000000000477.

    PMID: 34647912BACKGROUND
  • Jahantiqh F, Abdollahimohammad A, Firouzkouhi M, Ebrahiminejad V. Effects of Reiki Versus Physiotherapy on Relieving Lower Back Pain and Improving Activities Daily Living of Patients With Intervertebral Disc Hernia. J Evid Based Integr Med. 2018 Jan-Dec;23:2515690X18762745. doi: 10.1177/2515690X18762745.

    PMID: 29536776BACKGROUND
  • Vitale AT, O'Connor PC. The effect of Reiki on pain and anxiety in women with abdominal hysterectomies: a quasi-experimental pilot study. Holist Nurs Pract. 2006 Nov-Dec;20(6):263-72; quiz 273-4.

    PMID: 17099413BACKGROUND
  • Thrane S, Cohen SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain Manag Nurs. 2014 Dec;15(4):897-908. doi: 10.1016/j.pmn.2013.07.008. Epub 2014 Feb 28.

    PMID: 24582620BACKGROUND
  • Jones J. (2018). Use of Reiki for Pain Control in Post-Surgical Patients: A Critical Review of the literature. Thése de Master of Science in the Physician Assistant Program. University of North Carolina.

    BACKGROUND
  • Notte BB, Fazzini C, Mooney RA. Reiki's effect on patients with total knee arthroplasty: A pilot study. Nursing. 2016 Feb;46(2):17-23. doi: 10.1097/01.NURSE.0000476246.16717.65.

    PMID: 26760383BACKGROUND
  • Maqbool M., Javed S., Ahmed A. B. (2019). Assessment of Pain management in PostOperative Cases Using Different Scales and Questionnaires. Indo American Journal of Pharmaceutical Sciences, 6(1): 983-987. doi:

    BACKGROUND

MeSH Terms

Conditions

AnkylosisIntervertebral Disc DisplacementScoliosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesSpinal DiseasesBone DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSpinal Curvatures

Central Study Contacts

Bouchra BENKESSOU Chef de projet Recherche Clinique

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A comparative (intervention versus placebo), prospective, double-blind, single-centered pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

September 10, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Locations