Spinal Stenosis LumbarNCT06935201
Evaluation of a Digital Person-Centered Rehabilitation Program Targeting Physical Activity in Spinal Stenosis Surgery (Get Back)
A study testing Get Back in people with Spinal Stenosis Lumbar, run by Sophiahemmet University at 4 sites in Sweden.
Trial summary
This study aims to investigate whether Get Back is more effective than standard rehabilitation in increasing the number of steps per day, improving physical activity levels, and functional ability for patients undergoing surgery for lumbar spinal stenosis (LSS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- Get Back
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 4 sitesSweden
- Study dates
- 12 May 2025to May 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for decompression surgery due to central lumbar spinal stenosis
Who cannot join
- Patients with malignancy under treatment or with metastases;
- History of neurological or other disorders resulting in severe movement dysfunction;
- Untreated or instable heart conditions that prohibits physical tests;
- Poor understanding of Swedish.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Ryggkirurgiskt centrum Stockholm
Stockholm, 11433
- Recruiting
Södersjukhuset
Stockholm, 11861
- Recruiting
Akademiska sjukhuset
Uppsala, 75185
- Recruiting
Capio Spine Center Göteborg
Västra Frölunda, 42130
About this study
Official title: Get Back, A Digital Person-Centered Rehabilitation Program to Increase Physical Activity After Lumbar Spinal Stenosis Surgery - a Randomized Controlled Trial
This study aims to investigate whether Get Back is more effective than standard rehabilitation in increasing the number of steps per day, improving physical activity levels, and functional ability for patients undergoing surgery for lumbar spinal stenosis (LSS). LSS is common, especially among older adults, leading to increased health risks and reduced quality of life. Despite its prevalence (about 60% of all spinal surgeries in Sweden), many LSS patients remain physically inactive post-surgery, worsening their health. Rehabilitation remains a global challenge with unequal access, and many patients feel disengaged from the process. Get Back is a digital rehabilitation program including three components: gradually increasing physical activity, managing fear and avoidance behaviors, and using behavior change techniques. It has shown promising results in a pilot study, increasing daily steps. The program uses a person-centered approach tailored to personal needs. This multicenter randomized controlled trial will assess efficacy, process, and cost-effectiveness. It will also explore how preoperative values such as physical capacity and psychological factors predict changes in daily steps after surgery. Data will be collected via questionnaires, functional tests, and interviews, with the primary outcome being daily steps measured with motion sensors. The study will involve 252 patients from four spinal clinics. Get Back promotes increased physical activity and accessible rehabilitation, contributing to better health for LSS patients.
Read the detailed description
The Get Back rehabilitation program has been developed using the Medical Research Councils (MRC) framework. A feasibility study (NCT05806593) has been completed involving 29 patients (mean age 67) who underwent surgery for LSS. The Get Back intervention (completely digital i.e. assessments and rehabilitation) was shown to be feasible and resulted in clinically significant improvements in daily steps at 12 weeks' post-surgery.
To evaluate the effectiveness and process of Get Back a multicenter randomized controlled trial including three sub-studies will be conducted. The specific research questions we aim to investigate in this RCT are:
- if Get Back is more effective than standard rehabilitation in increasing daily steps (primary outcome) and physical activity behavior, disability, or pain-related factors (secondary outcomes) after surgery for LSS
- if Get Back is more cost effective than standard rehabilitation after surgery for LSS
- how baseline values (psychological factors, physical capacity and physical activity) predict changes in daily steps after surgery for LSS
- how participants' experiences contribute to an enhanced understanding of what impact the intervention content had on their physical activity behavior.
Patients will be recruited from four clinical study sites (two private spine clinics and two hospitals). All patients undergo a clinical examination by an orthopedic surgeon as part of standard preoperative care. If a surgical decision is made and the patient is placed on the waiting list, a local recruiter at each site will hand out written study information to the patients meeting inclusion criteria and ask if a physical therapist from the study can make contact to provide further information about the study and ask for participation. As the intervention is fully digital, the patient information in written will also be sent to the patient digitally.
At baseline (approx. 2 weeks pre-surgery), participants meet with an assessor (physical therapist) via a digital care platform for collection of demographic data, personal goals, and to conduct physical capacity tests. Questionnaires are sent out through a digital application and patients wear an accelerometer for 7 days sent out by mail. Outcome variables are described more in detail under the heading Outcome Measures in the trial registration. The follow-ups are scheduled at 6 weeks, 3 months, 6 months, and 1-year post-surgery. Accelerometry and questionnaires will be collected at each follow-up, whereas physical capacity tests will be conducted at 3 and 12 months post-surgery. Clinical data such as type of surgery, complications, discharge destination will be collected from the patients' medical records at 3 months post-surgery.
After baseline assessments, patients are randomly assigned (1:1) to either control or intervention group. The randomization will be based on a computerized random list converted to concealed envelopes. The assessor will be blinded to group allocation.
Participants in the intervention group (Get Back, n=126) will have one pre-surgery video session with a physical therapist, followed by up to five core video sessions and five booster telephone sessions over 13 weeks. Session frequency is decided collaboratively, based on person-centered care. The intervention includes three components: graded physical activity, addressing fear avoidance beliefs, and promoting behavior change. A person-centered health plan is created at the first session, based on the patient's story and baseline assessment. The plan includes personalized activity goals, monitored using a weekly physical activity diary to track steps, barriers, and progress. A sub-sample of the intervention group, approximately 15-20 participants, will be interviewed regarding their experiences of the intervention and intervention content at 3 months post-surgery using a semi-structured interview guide.
Participants in the control group (n=126) will follow standard rehabilitation (physical therapy as provided at each site). Data on the frequency and content of rehabilitating sessions during the study will be collected as a control variable at each follow-up assessment.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- Get Back
- Keywords
- Rehabilitation, Person-centred care, Physical activity, Steps per day, Behavioral medicine, Telerehabilitation, Telehealth
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Get BackBehavioural
A rehabilitation program, targeting physical activity behavior, with a person-centered approach led by a physical therapist during 12 weeks (1 week before surgery until 12 weeks after surgery) in a digital format.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Get Back) | Experimental | The intervention includes up to 5 core sessions (video call) and 5 booster sessions (telephone) over 13 weeks (approx. 1 week before until 12 weeks after surgery). All sessions will be led by a physical therapist. The focus of each core session (1-5) is as follows:
1. To establish the patient as an active, equal partner in the treatment and to formulate a shared health plan according to person-centered care.
2. To follow up with postoperative analysis and activity initiation.
3. To support graded physical activity by analysis, problem-solving, and behavioral strategies.
4. To support graded physical activity by analysis, problem-solving, and behavioral strategies.
5. To support the patient to independently continue with activity progress towards long term health and to formulate a maintenance plan. Receives: Behavioral: Get Back |
| Control (standard physical therapy) | No intervention | The control group will follow standard physical therapy, meaning physical therapy as it is provided at each recruiting site when undergoing surgery due to spinal stenosis. As this may differ substantially between clinical sites nationally, data on frequency of physical therapy and the content of the physical therapy sessions during the study period will be collected as a control variable from the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+).
Reported as number of steps per day. The primary endpoint is 3 months postoperatively.
Measured: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up
Secondary outcomes (11)
Physical activity level collected with a activity tracker/accelerometer (Actigraph GT3X+).
Reported as time spent in light physical activity, moderate to vigorous physical activity (MVPA) and time spent sedentary.
Measured: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up
Physical function measured with the Timed-up-and-go test (TUG).
The time it takes for a participant to rise from a chair, walk 3 meters, turn, walk back to the chair and sit down. Reported in seconds.
Measured: At preoperative baseline, 3 and 12 months postoperative follow-up.
Postural balance measured with the One Leg Stand test.
The time a participant can stand on one leg, reported in seconds.
Measured: At preoperative baseline, 3 and 12 months postoperative follow-up.
Functional leg strength measured with the 30 seconds sit-to-stand test.
Reported as the number of chair rises a participant can complete during 30 seconds.
Measured: At preoperative baseline, 3 and 12 months postoperative follow-up.
Pain intensity level in the leg and back reported with the Numeric Rating Scale (NRS).
On a scale from 0 to 10, where a higher reported number means higher pain intensity.
Measured: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.
Self-reported back-related disability collected with the Oswestry Disability Index (ODI).
Score range from 0 to 50. Higher scores represent greater disability.
Measured: At preoperative baseline, 3 and 12 months postoperative follow-up.
The person's own goals regarding function collected with the Patient Specific Functional Scale (PSFS).
The participant will choose three activities of individual importance and rate the ability to perform each activity on a scale from 0 (not able to perform the activity) to 10 (can perform the activity unhindered).
Measured: At preoperative baseline, 3 and 12 months postoperative follow-up.
Catastrophizing thoughts related to pain collected with the Pain Catastrophizing Scale (PCS).
Score range from 0 to 52. Higher scores mean higher degree of catastrophizing thoughts related to pain.
Measured: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up
Patient-reported kinesiophobia collected with the Swedish version of the Tampa Scale of Kinesiophobia (TSK-SV).
Score range from 17 to 68. Higher scores mean higher degree of fear of movement.
Measured: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.
Depressed mood collected with the depression subscale of the Hospital Anxiety and Depression Scale.
Score range from 0 to 21. A score of 8 or more indicates depression.
Measured: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.
Pain self-efficacy collected with the 2-item Pain Self-Efficacy Questionnaire (PSEQ-2).
The questions are rated on a scale from 0 (not at all confident) to 6 (completely confident). A score of 5 or less indicates that the person might be in need of help with their confidence in functioning in the presence of their pain. A score of 8 or higher reflects a desirable level of pain self-efficacy or confidence in functioning in the presence of pain.
Measured: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start12 May 2025
- Primary completionAug 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophiahemmet University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Göteborg University
- Responsible party
- Principal investigator, Mari Lundberg, Sophiahemmet University
- Investigators
- Mari K Lundberg, Principal investigator, Sophiahemmet University/Sophiahemmet Högskola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935201
- Sponsor's protocol ID
- Get Back RCT
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data in the study will be pseudonymized (coded) personal data, and Swedish legislation prohibits us from sharing this completely open. Some data is available upon request, which will be handled according to the relevant legislation.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Back, A Digital Person-Centered Rehabilitation Program to Increase Physical Activity After Lumbar Spinal Stenosis Surgery - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06935201
- Acronym / sponsor ID
- Get Back RCT
- Conditions
- Spinal Stenosis Lumbar
- Keywords
- Rehabilitation, Person-centred care, Physical activity, Steps per day, Behavioral medicine, Telerehabilitation, Telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Sophiahemmet UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Göteborg University
- Study start
- 12 May 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 Apr 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 aims to investigate whether Get Back is more effective than standard rehabilitation in increasing the number of steps per day, improving physical activity levels, and functional ability for patients undergoing surgery for lumbar spinal stenosis (LSS). LSS is common, especially among older adults, leading to increased health risks and reduced quality of life. Despite its prevalence (about 60% of all spinal surgeries in Sweden), many LSS patients remain physically inactive post-surgery, worsening their health. Rehabilitation remains a global challenge with unequal access, and many patients feel disengaged from the process. Get Back is a digital rehabilitation program including three components: gradually increasing physical activity, managing fear and avoidance behaviors, and using behavior change techniques. It has shown promising results in a pilot study, increasing daily steps. The program uses a person-centered approach tailored to personal needs. This multicenter randomized controlled trial will assess efficacy, process, and cost-effectiveness. It will also explore how preoperative values such as physical capacity and psychological factors predict changes in daily steps after surgery. Data will be collected via questionnaires, functional tests, and interviews, with the primary outcome being daily steps measured with motion sensors. The study will involve 252 patients from four spinal clinics. Get Back promotes increased physical activity and accessible rehabilitation, contributing to better health for LSS patients.
Detailed description
The Get Back rehabilitation program has been developed using the Medical Research Councils (MRC) framework. A feasibility study (NCT05806593) has been completed involving 29 patients (mean age 67) who underwent surgery for LSS. The Get Back intervention (completely digital i.e. assessments and rehabilitation) was shown to be feasible and resulted in clinically significant improvements in daily steps at 12 weeks' post-surgery.
To evaluate the effectiveness and process of Get Back a multicenter randomized controlled trial including three sub-studies will be conducted. The specific research questions we aim to investigate in this RCT are:
- if Get Back is more effective than standard rehabilitation in increasing daily steps (primary outcome) and physical activity behavior, disability, or pain-related factors (secondary outcomes) after surgery for LSS
- if Get Back is more cost effective than standard rehabilitation after surgery for LSS
- how baseline values (psychological factors, physical capacity and physical activity) predict changes in daily steps after surgery for LSS
- how participants' experiences contribute to an enhanced understanding of what impact the intervention content had on their physical activity behavior.
Patients will be recruited from four clinical study sites (two private spine clinics and two hospitals). All patients undergo a clinical examination by an orthopedic surgeon as part of standard preoperative care. If a surgical decision is made and the patient is placed on the waiting list, a local recruiter at each site will hand out written study information to the patients meeting inclusion criteria and ask if a physical therapist from the study can make contact to provide further information about the study and ask for participation. As the intervention is fully digital, the patient information in written will also be sent to the patient digitally.
At baseline (approx. 2 weeks pre-surgery), participants meet with an assessor (physical therapist) via a digital care platform for collection of demographic data, personal goals, and to conduct physical capacity tests. Questionnaires are sent out through a digital application and patients wear an accelerometer for 7 days sent out by mail. Outcome variables are described more in detail under the heading Outcome Measures in the trial registration. The follow-ups are scheduled at 6 weeks, 3 months, 6 months, and 1-year post-surgery. Accelerometry and questionnaires will be collected at each follow-up, whereas physical capacity tests will be conducted at 3 and 12 months post-surgery. Clinical data such as type of surgery, complications, discharge destination will be collected from the patients' medical records at 3 months post-surgery.
After baseline assessments, patients are randomly assigned (1:1) to either control or intervention group. The randomization will be based on a computerized random list converted to concealed envelopes. The assessor will be blinded to group allocation.
Participants in the intervention group (Get Back, n=126) will have one pre-surgery video session with a physical therapist, followed by up to five core video sessions and five booster telephone sessions over 13 weeks. Session frequency is decided collaboratively, based on person-centered care. The intervention includes three components: graded physical activity, addressing fear avoidance beliefs, and promoting behavior change. A person-centered health plan is created at the first session, based on the patient's story and baseline assessment. The plan includes personalized activity goals, monitored using a weekly physical activity diary to track steps, barriers, and progress. A sub-sample of the intervention group, approximately 15-20 participants, will be interviewed regarding their experiences of the intervention and intervention content at 3 months post-surgery using a semi-structured interview guide.
Participants in the control group (n=126) will follow standard rehabilitation (physical therapy as provided at each site). Data on the frequency and content of rehabilitating sessions during the study will be collected as a control variable at each follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Get Back) | Experimental | Behavioral: Get BackThe intervention includes up to 5 core sessions (video call) and 5 booster sessions (telephone) over 13 weeks (approx. 1 week before until 12 weeks after surgery). All sessions will be led by a physical therapist. The focus of each core session (1-5) is as follows: 1. To establish the patient as an active, equal partner in the treatment and to formulate a shared health plan according to person-centered care. 2. To follow up with postoperative analysis and activity initiation. 3. To support graded physical activity by analysis, problem-solving, and behavioral strategies. 4. To support graded physical activity by analysis, problem-solving, and behavioral strategies. 5. To support the patient to independently continue with activity progress towards long term health and to formulate a maintenance plan. |
| Control (standard physical therapy) | No intervention | –The control group will follow standard physical therapy, meaning physical therapy as it is provided at each recruiting site when undergoing surgery due to spinal stenosis. As this may differ substantially between clinical sites nationally, data on frequency of physical therapy and the content of the physical therapy sessions during the study period will be collected as a control variable from the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients planned for decompression surgery due to central lumbar spinal stenosis
Key exclusion criteria (4 listed)
- Patients with malignancy under treatment or with metastases;
- History of neurological or other disorders resulting in severe movement dysfunction;
- Untreated or instable heart conditions that prohibits physical tests;
- Poor understanding of Swedish.
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 |
|---|---|---|
| Get BackA rehabilitation program, targeting physical activity behavior, with a person-centered approach led by a physical therapist during 12 weeks (1 week before surgery until 12 weeks after surgery) in a digital format. | Behavioural | Intervention (Get Back) |
Primary outcome
Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+).
Time frame: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up
Reported as number of steps per day. The primary endpoint is 3 months postoperatively.
11 secondary outcomes
Physical activity level collected with a activity tracker/accelerometer (Actigraph GT3X+).
Time frame: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up
Physical function measured with the Timed-up-and-go test (TUG).
Time frame: At preoperative baseline, 3 and 12 months postoperative follow-up.
Postural balance measured with the One Leg Stand test.
Time frame: At preoperative baseline, 3 and 12 months postoperative follow-up.
Functional leg strength measured with the 30 seconds sit-to-stand test.
Time frame: At preoperative baseline, 3 and 12 months postoperative follow-up.
Pain intensity level in the leg and back reported with the Numeric Rating Scale (NRS).
Time frame: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.
Self-reported back-related disability collected with the Oswestry Disability Index (ODI).
Time frame: At preoperative baseline, 3 and 12 months postoperative follow-up.
The person's own goals regarding function collected with the Patient Specific Functional Scale (PSFS).
Time frame: At preoperative baseline, 3 and 12 months postoperative follow-up.
Catastrophizing thoughts related to pain collected with the Pain Catastrophizing Scale (PCS).
Time frame: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up
Patient-reported kinesiophobia collected with the Swedish version of the Tampa Scale of Kinesiophobia (TSK-SV).
Time frame: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.
Depressed mood collected with the depression subscale of the Hospital Anxiety and Depression Scale.
Time frame: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.
Pain self-efficacy collected with the 2-item Pain Self-Efficacy Questionnaire (PSEQ-2).
Time frame: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up.
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 28 Apr 2026.
- Individual participant dataSharing planned: No. The data in the study will be pseudonymized (coded) personal data, and Swedish legislation prohibits us from sharing this completely open. Some data is available upon request, which will be handled according to the relevant legislation.
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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.
Mari K Lundberg principal investigator
Sophiahemmet University/Sophiahemmet Högskola
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Get Back in people with Spinal Stenosis Lumbar, run by Sophiahemmet University at 4 sites in Sweden.
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 1 inclusion and 4 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 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
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 Mari K Lundberg (+46 8-406 20 91, mari.lundberg@shh.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps per day collected with a activity tracker/accelerometer (Actigraph GT3X+). (time frame: At preoperative baseline, and at 6 weeks, 3 months, 6 months, 12 months postoperative follow-up). 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 28 Apr 2026.