Single Level Spinal FusionI-MASSNCT06429072
Integration of Mindfulness and Acupuncture After Spine Surgery
A study testing Mindfulness training, Acupuncture and Enhanced education in people with Single Level Spinal Fusion and Discetomy, run by Duke University at 1 site in United States.
Trial summary
The Integration of Mindfulness and Acupuncture for individuals undergoing Spine Surgery (I-MASS) is a novel combination of integrative treatments to improve post-surgical recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Single Level Spinal Fusion, Discetomy, Laminectomy
- What is being tested?
- Mindfulness training, Acupuncture and Enhanced education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing single level fusion, discectomy or laminectomy of the cervical or lumbar spine for management of pain
- 18 years of age or older
- has access to a smartphone or mobile device (with android or iOS operating system) and internet to complete training and questionnaires.
Who cannot join
- have conditions making consent, follow-up data collection and/or use of the intervention prohibitive (e.g., Non-English speaking, serious psychiatric conditions [i.e., schizophrenia], traumatic brain injury, or dementia-type illness)
- undergoing surgery for neoplastic disease
- current daily opioid use greater than 100mg morphine equivalents
- unable to receive acupuncture due to injury, infection, or other contraindication to the use of needles at acupuncture sites
- not possible to attend outpatient clinic for AA follow-up (e.g., from out-of-state)
- currently practicing mindfulness or receiving acupuncture
- in Hospice, receiving palliative care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Sports Science Institute
Durham, North Carolina, 27705
About this study
Official title: Integration of Mindfulness and Acupuncture After Spine Surgery: Aim 2
The Integration of Mindfulness and Acupuncture for individuals undergoing Spine Surgery (I-MASS) is a novel combination of integrative treatments to improve post-surgical recovery.
This is a single-site, two-arm randomized feasibility and acceptability pilot trial of the I-MASS program plus enhanced patient education compared to enhanced patient education alone in patients undergoing spine surgery. Outcomes data will come from a combination of passive electronic health record data augmented with patient-reported data collected through the Pattern Health app (the mHealth platform used for delivering mindfulness training and collecting data). Outcomes will focus on feasibility and acceptability of I-MASS, feasibility of recruitment and retention strategies, and data collection procedures through both the Pattern Health app and electronic health record. Feasibility will be supported by mindfulness module completion rates, acupuncture visits attended, participant retention, and questionnaire completion rates. Acceptability will be supported by patient-reported satisfaction, acceptability and usability thresholds.
Read the detailed description
Participants will be randomized to one of two study arms: 1) the I-MASS program plus enhanced education or 2) the enhanced education intervention only.
I-MASS program plus enhanced education (Intervention) Arm: This arm begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app, discuss the benefits of combining mindfulness and acupuncture, discuss how to access the Healthwise educational content, and lead a brief (~10 min) mindfulness exercise, as desired. Thereafter, participants will complete 4 self-directed mindfulness modules through the Pattern Health app (1 prior to surgery, 3 following surgery). The modules will include a guided series of videos, audio files and interactive text features. Each week-long module includes daily sessions comprised of a short (4-5 min) background video, a 6-8 min guided mediation (users could choose either a female or male voice) and interactive suggestions for how to apply mindfulness within their daily routine (~10-12 min total per session). The pre-operative training (module 1) focuses on developing an awareness of breath, which is a fundamental mindfulness technique. Following surgery, participants will initiate training module 2, building awareness of body systems, followed by modules 3 and 4 over the subsequent 2 weeks. Automated activity reminders in the app will alert the participant to complete the daily session. Each module builds upon skills learned in the previous module and participants are encouraged to continue using learned skills and resources within the app after completion of the modules.
The initial acupuncture session will occur within one week prior to surgery. The second acupuncture session will occur within the first week following surgery. Afterwards, participants will receive acupuncture in participating community outpatient clinics for up to 8 sessions total within 12 weeks of surgery. The investigators will allow flexibility in scheduling these visits with a window of 5-10 days between acupuncture sessions. Acupuncturists will also be trained to facilitate discussion about mindful awareness and non-judgmental thoughts regarding pain, giving participants an opportunity to reflect on their experiences during the acupuncture session. Auricular acupuncture will be the preferred form of acupuncture used. If participants are unable to tolerate auricular acupuncture, they will have the option to receive peripheral acupuncture.
The program consists of enhanced education prior to and after surgery for all participants. All of the educational material is delivered via the Pattern Health App. All educational content is from the Healtwise.net Duke Health Library (https://www.healthwise.net/dukehealth/Content) and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery. Educational topics include learning how to lift and sit when experiencing pain, proper precautions following surgery, how to ease back into daily activities following surgery, and ways to self-manage pain. Education is in the form of short reading materials or videos, all designed to help safely and effectively recover from surgery.
Enhanced Education Arm: Participants in this arm will receive an introductory call from study staff to introduce the participant to the Pattern Health app, discuss how to access the Healthwise educational content, and answer any questions about the program. They will then receive the same course of enhanced educational material as the Intervention arm in the Pattern Health app.
All trial participants will not be prevented from receiving any other care deemed necessary by their health care team and surgeon. This program is designed to complement their usual care, not replace it. Participant involvement with the study will be complete at 3 months following surgery. All follow-up questionnaires will be administered through the Pattern Health app for participants in both study arms.
- Conditions
- Single Level Spinal Fusion, Discetomy, Laminectomy
- Being tested
- Mindfulness training, Acupuncture, Enhanced education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
- I-MASS begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app, discuss the benefits of combining mindfulness and acupuncture, discuss how to access the Healthwise educational content, and lead a brief (~10 min) mindfulness exercise, as desired. Thereafter, participants will complete 4 self-directed mindfulness modules through the Pattern Health app (1 prior to surgery, 3 following surgery). Each mindfulness module is anticipated to last one week and includes a short (4-5 min) introductory video, daily sessions comprised of a 6-8 min guided mediation, and interactive suggestions for how to apply mindfulness within a daily routine (~10-12 min total per daily session).
AcupunctureOther
This arm also includes up to 8 total acupuncture treatments (1 prior to surgery and up to 7 treatments in the 12 weeks after surgery). Auricular acupuncture will be the preferred form of acupuncture used. This technique involves inserting tiny needles in specific areas of the outer ear to target points believed to influence pain. If participants are unable to tolerate auricular acupuncture, they will have the option to receive peripheral acupuncture.
Enhanced educationBehavioural
- The program consists of education prior to and after surgery for all participants. All of the educational material is delivered via the Pattern Health App. All educational content is from the Healthwise.net Duke Health Library (https://www.healthwise.net/dukehealth/Content) and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery. Education is in the form of short reading materials or videos, all designed to help safely and effectively recover from surgery. Educational topics include learning how to lift and sit when experiencing pain, proper precautions following surgery, how to ease back into daily activities following surgery, and ways to self-manage pain.
| Study group | Role | What they receive |
|---|---|---|
| I-MASS Program plus Enhanced Education | Experimental | Not described Receives: Behavioral: Mindfulness training; Other: Acupuncture; Behavioral: Enhanced education |
| Enhanced Education Intervention Only | Active comparator | Not described Receives: Behavioral: Enhanced education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 assesses credibility and satisfaction with health-related services (8 items, 4-point Likert, with higher scores indicating higher credibility/satisfaction).
Measured: up to 3 months post-surgery
Recruitment
Percentage of contacted patients that are eligible and agree to participate
Measured: up to 3 months post-surgery
Data Collection
Percentage of participants who complete self-report follow-up questionnaires at each of the 4 timepoints.
Measured: up to 3 months post-surgery
Number of completed acupuncture visits
Percentage of acupuncture visits completed out of 8 possible visits
Measured: up to 3 months post-surgery
Number of completed mindfulness modules
Percentage of completed mindfulness modules out of 4 possible in the Pattern Health app
Measured: up to 3 months post-surgery
Secondary outcomes (6)
PROMIS-29 v2. 0
This profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain and a one-item measure of pain intensity. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.
Measured: Baseline (prior to surgery), 2weeks, 6weeks, 3 months post-surgery
Daily Pain Intensity
Daily pain intensity during the week prior to surgery and for two weeks following surgery will be measured with the following two questions: 1) Please rate your worst pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst possible pain), and 2) Please rate your average pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst possible pain). These measures will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.
Measured: week before surgery, for 2 weeks after surgery
SPARE Fear Avoidance Short-form
The SPARE-FA short form is a 4 item questionnaires that measures characteristics of pain-related fear avoidance, catastrophizing, and kinesiophobia. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.
Measured: Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery
Medication Prescriptions
We will collect self-reported information on medication prescriptions for pain (e.g., Opioids, Benzodiazepines, Gabapentin/Neurontin, NSAIDs) at baseline, 6 weeks, and 3 months. We will also collect self-reported pain medication use daily during the first 2 weeks following surgery. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.
Measured: Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery
Number of hospital readmission's related to spine surgery
ADT alerts in the Epic EHR and periodic chart reviews through 3 months. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.
Measured: up to 3 months post-surgery
Number of emergency room visits related to Spine.
ADT alerts in the Epic EHR and periodic chart reviews through 3 months. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.
Measured: up to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 Aug 2024
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single Level Spinal FusionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trevor Lentz, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429072
- Sponsor's protocol ID
- Pro00114814
- Acronym
- I-MASS
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lentz TA, Porter LS, McGarvey L, Rhodes C, Rocos B, Gremore T, Reinke EK, Eucker SA, Green CL, Poehlein E, Dixon A, Mill M, Finley S, Goertz CM. Integration of Mindfulness and Acupuncture After Spine Surgery: Protocol for a Randomized Acceptability and Feasibility Trial. JMIR Res Protoc. 2025 Nov 17;14:e77236. doi: 10.2196/77236.
PubMed 41247820
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Mindfulness and Acupuncture After Spine Surgery: Aim 2
- ClinicalTrials.gov ID
- NCT06429072
- Acronym / sponsor ID
- I-MASS / Pro00114814
- Conditions
- Single Level Spinal Fusion, Discetomy, Laminectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 24 May 2024 (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.
The Integration of Mindfulness and Acupuncture for individuals undergoing Spine Surgery (I-MASS) is a novel combination of integrative treatments to improve post-surgical recovery.
This is a single-site, two-arm randomized feasibility and acceptability pilot trial of the I-MASS program plus enhanced patient education compared to enhanced patient education alone in patients undergoing spine surgery. Outcomes data will come from a combination of passive electronic health record data augmented with patient-reported data collected through the Pattern Health app (the mHealth platform used for delivering mindfulness training and collecting data). Outcomes will focus on feasibility and acceptability of I-MASS, feasibility of recruitment and retention strategies, and data collection procedures through both the Pattern Health app and electronic health record. Feasibility will be supported by mindfulness module completion rates, acupuncture visits attended, participant retention, and questionnaire completion rates. Acceptability will be supported by patient-reported satisfaction, acceptability and usability thresholds.
Detailed description
Participants will be randomized to one of two study arms: 1) the I-MASS program plus enhanced education or 2) the enhanced education intervention only.
I-MASS program plus enhanced education (Intervention) Arm: This arm begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app, discuss the benefits of combining mindfulness and acupuncture, discuss how to access the Healthwise educational content, and lead a brief (~10 min) mindfulness exercise, as desired. Thereafter, participants will complete 4 self-directed mindfulness modules through the Pattern Health app (1 prior to surgery, 3 following surgery). The modules will include a guided series of videos, audio files and interactive text features. Each week-long module includes daily sessions comprised of a short (4-5 min) background video, a 6-8 min guided mediation (users could choose either a female or male voice) and interactive suggestions for how to apply mindfulness within their daily routine (~10-12 min total per session). The pre-operative training (module 1) focuses on developing an awareness of breath, which is a fundamental mindfulness technique. Following surgery, participants will initiate training module 2, building awareness of body systems, followed by modules 3 and 4 over the subsequent 2 weeks. Automated activity reminders in the app will alert the participant to complete the daily session. Each module builds upon skills learned in the previous module and participants are encouraged to continue using learned skills and resources within the app after completion of the modules.
The initial acupuncture session will occur within one week prior to surgery. The second acupuncture session will occur within the first week following surgery. Afterwards, participants will receive acupuncture in participating community outpatient clinics for up to 8 sessions total within 12 weeks of surgery. The investigators will allow flexibility in scheduling these visits with a window of 5-10 days between acupuncture sessions. Acupuncturists will also be trained to facilitate discussion about mindful awareness and non-judgmental thoughts regarding pain, giving participants an opportunity to reflect on their experiences during the acupuncture session. Auricular acupuncture will be the preferred form of acupuncture used. If participants are unable to tolerate auricular acupuncture, they will have the option to receive peripheral acupuncture.
The program consists of enhanced education prior to and after surgery for all participants. All of the educational material is delivered via the Pattern Health App. All educational content is from the Healtwise.net Duke Health Library (https://www.healthwise.net/dukehealth/Content) and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery. Educational topics include learning how to lift and sit when experiencing pain, proper precautions following surgery, how to ease back into daily activities following surgery, and ways to self-manage pain. Education is in the form of short reading materials or videos, all designed to help safely and effectively recover from surgery.
Enhanced Education Arm: Participants in this arm will receive an introductory call from study staff to introduce the participant to the Pattern Health app, discuss how to access the Healthwise educational content, and answer any questions about the program. They will then receive the same course of enhanced educational material as the Intervention arm in the Pattern Health app.
All trial participants will not be prevented from receiving any other care deemed necessary by their health care team and surgeon. This program is designed to complement their usual care, not replace it. Participant involvement with the study will be complete at 3 months following surgery. All follow-up questionnaires will be administered through the Pattern Health app for participants in both study arms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-MASS Program plus Enhanced Education | Experimental | Behavioral: Mindfulness training, Other: Acupuncture, Behavioral: Enhanced education |
| Enhanced Education Intervention Only | Active comparator | Behavioral: Enhanced education |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing single level fusion, discectomy or laminectomy of the cervical or lumbar spine for management of pain
- 18 years of age or older
- has access to a smartphone or mobile device (with android or iOS operating system) and internet to complete training and questionnaires.
Key exclusion criteria (7 listed)
- have conditions making consent, follow-up data collection and/or use of the intervention prohibitive (e.g., Non-English speaking, serious psychiatric conditions [i.e., schizophrenia], traumatic brain injury, or dementia-type illness)
- undergoing surgery for neoplastic disease
- current daily opioid use greater than 100mg morphine equivalents
- unable to receive acupuncture due to injury, infection, or other contraindication to the use of needles at acupuncture sites
- not possible to attend outpatient clinic for AA follow-up (e.g., from out-of-state)
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 |
|---|---|---|
| Mindfulness training• I-MASS begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app, discuss the benefits of combining mindfulness and acupuncture, discuss how to access the Healthwise educational content, and lead a brief (~10 min) mindfulness exercise, as desired. Thereafter, participants will complete 4 self-directed mindfulness modules through the Pattern Health app (1 prior to surgery, 3 following surgery). Each mindfulness module is anticipated to last one week and includes a short (4-5 min) introductory video, daily sessions comprised of a 6-8 min guided mediation, and interactive suggestions for how to apply mindfulness within a daily routine (~10-12 min total per daily session). | Behavioural | I-MASS Program plus Enhanced Education |
| AcupunctureThis arm also includes up to 8 total acupuncture treatments (1 prior to surgery and up to 7 treatments in the 12 weeks after surgery). Auricular acupuncture will be the preferred form of acupuncture used. This technique involves inserting tiny needles in specific areas of the outer ear to target points believed to influence pain. If participants are unable to tolerate auricular acupuncture, they will have the option to receive peripheral acupuncture. | Other | I-MASS Program plus Enhanced Education |
| Enhanced education• The program consists of education prior to and after surgery for all participants. All of the educational material is delivered via the Pattern Health App. All educational content is from the Healthwise.net Duke Health Library (https://www.healthwise.net/dukehealth/Content) and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery. Education is in the form of short reading materials or videos, all designed to help safely and effectively recover from surgery. Educational topics include learning how to lift and sit when experiencing pain, proper precautions following surgery, how to ease back into daily activities following surgery, and ways to self-manage pain. | Behavioural | Enhanced Education Intervention Only, I-MASS Program plus Enhanced Education |
Primary outcome
Client Satisfaction Questionnaire (CSQ-8)
Time frame: up to 3 months post-surgery
The CSQ-8 assesses credibility and satisfaction with health-related services (8 items, 4-point Likert, with higher scores indicating higher credibility/satisfaction).
Recruitment
Time frame: up to 3 months post-surgery
Percentage of contacted patients that are eligible and agree to participate
Data Collection
Time frame: up to 3 months post-surgery
Percentage of participants who complete self-report follow-up questionnaires at each of the 4 timepoints.
Number of completed acupuncture visits
Time frame: up to 3 months post-surgery
Percentage of acupuncture visits completed out of 8 possible visits
Number of completed mindfulness modules
Time frame: up to 3 months post-surgery
Percentage of completed mindfulness modules out of 4 possible in the Pattern Health app
6 secondary outcomes
PROMIS-29 v2. 0
Time frame: Baseline (prior to surgery), 2weeks, 6weeks, 3 months post-surgery
Daily Pain Intensity
Time frame: week before surgery, for 2 weeks after surgery
SPARE Fear Avoidance Short-form
Time frame: Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery
Medication Prescriptions
Time frame: Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery
Number of hospital readmission's related to spine surgery
Time frame: up to 3 months post-surgery
Number of emergency room visits related to Spine.
Time frame: up to 3 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 41247820Lentz TA, Porter LS, McGarvey L, Rhodes C, Rocos B, Gremore T, Reinke EK, Eucker SA, Green CL, Poehlein E, Dixon A, Mill M, Finley S, Goertz CM. Integration of Mindfulness and Acupuncture After Spine Surgery: Protocol for a Randomized Acceptability and Feasibility Trial. JMIR Res Protoc. 2025 Nov 17;14:e77236. doi: 10.2196/77236.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Trevor Lentz, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training, Acupuncture and Enhanced education in people with Single Level Spinal Fusion and Discetomy, run by Duke University at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 19 Nov 2025. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (CSQ-8) (time frame: up to 3 months post-surgery). The study lists 5 primary outcomes in all. 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 NCT06429072, which also lists 1 linked publication.
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 19 Nov 2025.