Chirurgical InterventionREDALNCT07062146
Evaluation of the Effect of Reiki on Pain After Spinal Fusion
A study testing reiki in people with Chirurgical Intervention, run by Clinique Bizet at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chirurgical Intervention
- What is being tested?
- reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2025to 31 Jan 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
georges ABI LAHOUD, Professeur contact
France1 site, 1 recruiting
- Recruiting
Clinique Bizet
Paris, 75016
Bouchra BENKESSOU, PM, 0764486016, b.benkessou@hexagone-sante-paris.fr
Georges ABI LAHOUD, Principal Investigator
About this study
Official title: Evaluation of the Effect of Reiki on Pain After Spinal Fusion: A Comparative, Randomized, Pilot Study
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
- Being tested
- reiki, Sham (No Treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reikiOther
Reiki sessions for 30 minutes, on Day-7 before the surgery and on D15 after the surgery
Sham (No Treatment)Other
Sham sessions for 30 minutes, on D-7 before the surgery and on D15 after the surgery,
| Study group | Role | What they receive |
|---|---|---|
| standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki) | Experimental | treatment with reiki session Receives: Other: reiki |
| standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham) | Placebo comparator | treatment with sham session Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: DAY 15
Secondary outcomes (5)
Quality of life will be assessed using the SF12
The SF-12 (Short-Form Health Survey) a validated questionnaire designed to assess health-related quality of life across physical and mental domains. It is a shortened version of the SF-36, containing 12 items that cover eight key health dimensions.
Scoring:
- Higher scores indicate better health status in each domain
- Each item uses Likert-type responses ("Excellent" to "Poor", or "All of the time" to "None of the time")
Measured: DAY 30
Daily pain intensity will be reported
This daily diary was designed by the research team to record pain intensity using the Visual Analog Scale (VAS), from the day of discharge up to 30 days post-intervention.
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
Measured: from Day 1 to Day 30
evaluation of patient's overall satisfaction and treatment response
the Clinical Global Impression (CGI) is a clinician-rated scale used to assess the global change in a patient's condition following a medical or therapeutic intervention, compared to their state at baseline.
Evaluated on a 7-point scale :
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
Measured: at Day 30
Assessment of the condition of the scar at the lumbar level
The International Visual Wound Color Scale (IVWCS) This scale is a visual assessment tool that helps clinicians evaluate wound healing by identifying and interpreting the dominant colors present in the wound bed.
Each color corresponds to a specific tissue type or healing stage.
Color Categories and Their Meanings:
- Red: Indicates healthy granulation tissue, which is essential for wound repair. Suggests active healing and good blood supply Requires protection and monitoring for infection
- Yellow: Often associated with slough or exudate, which may signal infection or delayed healing.
Requires cleaning and possibly debridement May indicate microbial presence or inflammation
- Black: Represents necrotic tissue (dead tissue), often due to poor blood supply.
Requires urgent medical attention Typically treated with debridement and moist dressings
Measured: at Day 15 and Day 30
antalgic consumption will be reported
This daily diary was designed by the research team and records the daily consumption of analgesics from the day of discharge to 30 days post-intervention.
Classification of Analgesics in the Daily Diary Analgesic consumption will be categorized according to the standard analgesic step classification:
- Step 1: Non-opioid analgesics (paracetamol, NSAIDs)
- Step 2: Weak opioids (codeine, tramadol)
- Step 3: Strong opioids (morphine, fentanyl)
Measured: from day 1 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start9 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chirurgical InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062146
- Sponsor's protocol ID
- 2024-A02685-42
- Acronym
- REDAL
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Reiki on Pain After Spinal Fusion: A Comparative, Randomized, Pilot Study
- ClinicalTrials.gov ID
- NCT07062146
- Acronym / sponsor ID
- REDAL / 2024-A02685-42
- Conditions
- Chirurgical Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki) | Experimental | Other: reikitreatment with reiki session |
| standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham) | Placebo comparator | Other: Sham (No Treatment)treatment with sham session |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reikiReiki sessions for 30 minutes, on Day-7 before the surgery and on D15 after the surgery | Other | standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki) |
| Sham (No Treatment)Sham sessions for 30 minutes, on D-7 before the surgery and on D15 after the surgery, | Other | standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham) |
Primary outcome
pain will be assessed at Day 15 using the VAS ( Visial Analog Scale)
Time frame: DAY 15
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
georges ABI LAHOUD, Professeur contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reiki in people with Chirurgical Intervention, run by Clinique Bizet at 1 site 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 9 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 1 site 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, PM (0033140693525, 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?
pain will be assessed at Day 15 using the VAS ( Visial Analog Scale) (time frame: DAY 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.