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The Lumbar Spine Surgical InterventionREDALNCT07722117

Evaluation of the Effect of Reiki on Pain After Lumbar Surgery

A study testing Reiki treatment and chirurgy in people with The Lumbar Spine Surgical Intervention and Arthrodesis, run by Clinique Bizet at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Reiki treatment and chirurgy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesFrance
Study dates
10 Sep 2025to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bouchra BENKESSOU Chef de projet Recherche Clinique contact

+33 7 64 48 60 16

b.benkessou@hexagone-sante-paris.fr

France2 sites, 2 recruiting
  • Benkessou

    Paris, 75016

    benkessou BOUCHRA, 0764486016, b.benkessou@hexagone-sante-paris.fr

    Recruiting
  • Bizet Clinic

    Paris, 75016

    benkessou BOUCHRA, 0764486016, b.benkessou@cliniques-bltparis.fr

    Recruiting

Other trials in France

About this study

Official title: Evaluation of the Effect of Reiki on Pain After Lumbar Surgery: A Comparative Randomized, Double-blind, Pilot Study

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:

Read more

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).
Read the detailed description

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 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.

Being tested
Reiki treatment and chirurgy, Sham treatment and chirurgy
Keywords
scoliosis, NSAIDs, surgery for lumbar herniated disc, Reiki, energy therapy, the positive effect of energy therapy on pain reduction, alternative to reduce analgesic dependence
Medical subject headings
Ankylosis, Intervertebral Disc Displacement, Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reiki treatment and chirurgyOther

    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.

  • Sham treatment and chirurgyOther

    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.

Study groups in NCT07722117
Study groupRoleWhat they receive
Group A treated with ReikiExperimentalStandard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki).
Receives: Other: Reiki treatment and chirurgy
Groupe B control treated with ShamSham comparatorstandard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)
Receives: Other: Sham treatment and chirurgy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 30 days

Secondary outcomes (5)
  1. 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)

    Measured: 30 days

  2. 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)

    Measured: 30 days

  3. 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

    Measured: 30 days

  4. 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.

    Measured: 30 days

  5. 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)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2026
  2. Study start10 Sep 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A comparative (intervention versus placebo), prospective, double-blind, single-centered pilot study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07722117
Sponsor's protocol ID
2024-A02685-42-1
Acronym
REDAL
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38872168
  • 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.

    PubMed 34647912
  • 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.

    PubMed 29536776
  • 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.

    PubMed 17099413
  • 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.

    PubMed 24582620
  • 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.

  • 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.

    PubMed 26760383
  • 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:

Questions about this trial

What is this clinical trial studying?

A study testing Reiki treatment and chirurgy in people with The Lumbar Spine Surgical Intervention and Arthrodesis, run by Clinique Bizet at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bouchra BENKESSOU Chef de projet Recherche Clinique (+33 7 64 48 60 16, b.benkessou@hexagone-sante-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07722117, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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