Breast CancerNCT07068347
Comparison Of VR & CPT, With And Without Lifestyle Modification, On ULD In Breast Cancer Survivors
A study testing VR + lifestyle modification, VR only and Conventional physical therapy + lifestyle modification in people with Breast Cancer, run by Superior University at 3 sites in Pakistan.
Trial summary
The proposed study will compare the effect of an application of non-immersive virtual reality (VR) and conventional physical therapy (CPT) with and without lifestyle changes on upper limb dysfunction in breast cancer survivors, post-surgery. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- VR + lifestyle modification, VR only and Conventional physical therapy + lifestyle modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesPakistan
- Study dates
- 17 Apr 2025to 1 Jun 2026
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female breast cancer survivors aged 30-60 years.
- Women with breast cancer who have undergone any type of breast cancer surgery (e.g., mastectomy, lumpectomy, or breast reconstruction), regardless of the specific surgical procedure will be included.
- Participants able to carry on upper limb and whole-body physical activity will be included.
- Participants able to use smart devices such as mobile phones and computers will be included.
- Patients obtaining a physician's clearance for fitness testing and exercise will be included.
- Patients having no physical limitations prohibiting exercise will be included.
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- Patients diagnosed with grade 0-3 of breast cancer who had undergone surgery will be included.
- who were currently in the 2nd ~ 4th months after cancer surgery.
- Presence of upper limb dysfunction (e.g., pain, reduced range of motion and weakness).
Who cannot join
- Subjects suffering from active malignant tumors or bilateral breast cancer.
- Participants disabling physical or psychological ailments not allowing them to participate in the intervention .
- Patients who had lymphedema will be excluded.
- Participants with visual disorders that interfered with a video game- based exercise.
- Subjects with cognitive disorders, mental disorders, or cooperation issues will be excluded.Subjects with vascular or cardiopulmonary disorders.
- Subjects with previous breast cancer surgery on the present or contralateral side.
- Participants having upper extremity ROM limitation before the surgery will be excluded.
- Participants with presence of pace-maker, infection, open wounds, or wound drains will be excluded.
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Kinifit Physiotherapy Center
Islamabad
District Head Quarters Hospital
Rawalpindi, Punjab Province
Holy Family Hospital
Rawalpindi, Punjab Province
About this study
Official title: Comparison Of Virtual Reality And Conventional Physical Therapy, With And Without Life Style Modification, On Upper Limb Dysfunction In Post-Surgical Breast Cancer Survivors
The proposed study will compare the effect of an application of non-immersive virtual reality (VR) and conventional physical therapy (CPT) with and without lifestyle changes on upper limb dysfunction in breast cancer survivors, post-surgery. The purpose of this proposed RCT is to compare the effect of VR alone/in conjunction with lifestyle changes to that of CPT alone/in conjunction with lifestyle changes for the physical rehabilitation of female breast cancer survivors. Research will be conducted on 60 patients. This research employs parallel, randomized clinical trial design, which shall be conducted in NORI hospital, Shifa International Hospital and Kinifit physiotherapy in Islamabad/Rawalpindi over a period of 18 months. Thus, the type of sampling done in this study is purposive sampling.
Read the detailed description
Primary Objectives:
- To compare the effects of immersive virtual reality and conventional physical therapy, with and without lifestyle modification, on upper limb functional disability in post-surgical breast cancer survivors. Secondary Objectives:
- To assess the effects of immersive virtual reality compared to conventional physical therapy, with and without lifestyle modification, on improving pain, shoulder range of motion and muscle strength in post-surgical breast cancer survivors.
- To determine the effects of immersive virtual reality compared to conventional physical therapy with and without lifestyle modification on quality of life and psychological wellbeing in post-surgical breast cancer survivors.
- To evaluate self-reported adherence to the life style modification program among post-surgical breast cancer survivors.
- Conditions
- Breast Cancer
- Being tested
- VR + lifestyle modification, VR only, Conventional physical therapy + lifestyle modification, Conventional physical therapy only
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR + lifestyle modificationCombination product
VR + lifestyle modification (Warm up,In VR kinetic sports I Bowling, Darts,Golf,Boxing,Beach Volleyball ,Table Tennis,Fruit Ninja)Passive glenohumeral joint mobilization,Scar tissue massage.In lifestyle modification walking at home for 30 min in 3-5 days /week. Dietry habits will be given according to American Institute for cancer Research.
In sleep habits Recommended Sleep Hours 7-9 hours per night,Establish a Consistent Sleep Schedule,Create a Comfortable Sleep Environment,Limit Screen Time Before Bed,Engage in Relaxation Techniques,Limit Caffeine and Alcohol Intake,Manage Nighttime Discomfort,Maintain a Pre-Sleep Routine,Address Emotional Health,Avoid Daytime Naps.Deep breathing exercise for stress management
VR onlyCombination product
VR only (Warm up,In VR kinetic sports I Bowling, Darts,Golf,Boxing,Beach Volleyball ,Table Tennis,Fruit Ninja)Passive glenohumeral joint mobilization,Scar tissue massage.
Conventional physical therapy + lifestyle modificationCombination product
Conventional physical therapy + lifestyle modification In Conventional physical therapy(Pumping exercise for upper limb,Pendulum exercises ,Shrugs for shoulder and rotations,In sitting position arms up with clasped hands ,Shoulder rotation (arms on sides-arms in abduction),Arms up with hands clasped again but in lying position ,Wand exercises ,M. pectoralis major-M. Pectoralis Minor stretches in supine and standing positions,Snow angels,Front and lateral climbing on wall ,Trunk rotation in standing position (in sitting position, if not tolerated)
Conventional physical therapy onlyCombination product
Conventional physical therapy only((Pumping exercise for upper limb,Pendulum exercises ,Shrugs for shoulder and rotations,In sitting position arms up with clasped hands ,Shoulder rotation (arms on sides-arms in abduction),Arms up with hands clasped again but in lying position ,Wand exercises ,M. pectoralis major-M. Pectoralis Minor stretches in supine and standing positions,Snow angels,Front and lateral climbing on wall ,Trunk rotation in standing position (in sitting position, if not tolerated) ,Trunk lateral flexion with arms in 90 degrees abduction in standing position,Theraband (flexion-extension-abduction, adduction and internal-external rotation),Muscles of upper limb strengthening ,Mobilization for passive glenohumeral joint ,Tissue massage for scars.
| Study group | Role | What they receive |
|---|---|---|
| VR + lifestyle modification | Experimental | Not described Receives: Combination Product: VR + lifestyle modification |
| VR only | Active comparator | Not described Receives: Combination Product: VR only |
| Conventional physical therapy + lifestyle modification | Active comparator | Not described Receives: Combination Product: Conventional physical therapy + lifestyle modification |
| Conventional physical therapy only | Active comparator | Not described Receives: Combination Product: Conventional physical therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Upper limb dysfunction can be assessed using a combination of pain evaluation, range of motion measurements, and muscle strength testing. Pain is typically recorded using the Visual Analog Scale (VAS), where the patient marks their perceived pain level along a 10-centimeter horizontal line, with 0 indicating no pain and 10 representing the worst imaginable pain.
Measured: 18 Months
Goniometer (shoulder flexion, abduction, external rotation)
Scoring details: The score is determined by measuring the distance in centimeters from the 'no pain' end to the patient's mark. Range of motion (ROM) is assessed using a goniometer for key movements such as shoulder flexion, abduction, and external rotation. The angles achieved are measured in degrees and compared against established normative values typically 0° to 180° for flexion and abduction, and 0° to 90° for external rotation to identify limitations.
Measured: 18 Months
Handheld dynamometer
Muscle strength is evaluated using a handheld dynamometer, measuring the force produced by muscle groups like shoulder flexors, abductors, and external rotators. Strength is recorded in kilograms or newtons, usually averaging three trials, and compared to normative data or the unaffected limb to determine the degree of weakness. Together, these measures provide a comprehensive functional profile of the upper limb.
Measured: 18 Months
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Functional outcomes for individuals with upper limb dysfunction can be evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, a widely used, standardized, self-reported measure. The DASH consists of 30 items that assess the patient's ability to perform various physical activities, severity of symptoms, and impact on social and work-related tasks involving the upper extremity. Each item is rated on a 5-point Likert scale, ranging from 1 (no difficulty or no symptoms) to 5 (unable to perform activity or extreme symptoms). The scores from all completed items are summed, averaged, and then transformed into a score out of 100, where 0 indicates no disability and 100 represents the most severe disability. This tool provides valuable insight into the patient's perceived functional status and the extent to which upper limb issues interfere with daily life and occupational tasks.
Measured: 18 Months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
his is a validated, multidimensional, self-administered questionnaire designed to evaluate overall health-related quality of life in patients with chronic illness or undergoing treatment. The QLQ-C30 consists of 30 items covering several domains, including five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/quality of life scale, and several single-item assessments for additional symptoms such as insomnia, appetite loss, and financial difficulties. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much), except for the two global health status items, which use a 7-point scale. Scores are transformed to a scale from 0 to 100, with higher scores on the functional and global health scales indicating better functioning and quality of life, while higher scores on the symptom scales reflect greater symptom burden.
Measured: 18 Months
Hospital Anxiety and Depression Scale (HADS)
The HADS consists of 14 items, divided equally into two subscales: seven items assess symptoms of anxiety (HADS-A) and seven assess symptoms of depression (HADS-D). Each item is scored on a 4-point Likert scale ranging from 0 to 3, with total scores for each subscale ranging from 0 to 21. Scores are interpreted as follows: 0-7 indicates a normal range, 8-10 suggests possible anxiety or depression, and 11-21 indicates probable or clinically significant anxiety or depression.
Measured: 18 Months
Self-reported adherence to the lifestyle modification program through weekly logs.
The Health-Promoting Lifestyle Profile II (HPLP-II) is scored using a 4-point Likert scale (Never, Sometimes, Often, Routinely) for each of its 52 items. The overall score is calculated as the mean of all item responses, and this mean score is then categorized into four levels: Poor, Moderate, Good, and Excellent. The collected data provides insight into patient engagement, consistency in following health recommendations, and potential barriers to adherence. Regular review of these weekly logs allows clinicians or researchers to track progress, identify patterns of non-compliance, and offer timely support or program adjustments to improve health behaviors and functional recovery outcomes.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start17 Apr 2025
- Primary completion1 Dec 2025
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068347
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2223
- Status last verified
- Jan 2026
- First submitted
- 7 Jul 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Virtual Reality And Conventional Physical Therapy, With And Without Life Style Modification, On Upper Limb Dysfunction In Post-Surgical Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07068347
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2223
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 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.
The proposed study will compare the effect of an application of non-immersive virtual reality (VR) and conventional physical therapy (CPT) with and without lifestyle changes on upper limb dysfunction in breast cancer survivors, post-surgery. The purpose of this proposed RCT is to compare the effect of VR alone/in conjunction with lifestyle changes to that of CPT alone/in conjunction with lifestyle changes for the physical rehabilitation of female breast cancer survivors. Research will be conducted on 60 patients. This research employs parallel, randomized clinical trial design, which shall be conducted in NORI hospital, Shifa International Hospital and Kinifit physiotherapy in Islamabad/Rawalpindi over a period of 18 months. Thus, the type of sampling done in this study is purposive sampling.
Detailed description
Primary Objectives:
- To compare the effects of immersive virtual reality and conventional physical therapy, with and without lifestyle modification, on upper limb functional disability in post-surgical breast cancer survivors. Secondary Objectives:
- To assess the effects of immersive virtual reality compared to conventional physical therapy, with and without lifestyle modification, on improving pain, shoulder range of motion and muscle strength in post-surgical breast cancer survivors.
- To determine the effects of immersive virtual reality compared to conventional physical therapy with and without lifestyle modification on quality of life and psychological wellbeing in post-surgical breast cancer survivors.
- To evaluate self-reported adherence to the life style modification program among post-surgical breast cancer survivors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VR + lifestyle modification | Experimental | Combination Product: VR + lifestyle modification |
| VR only | Active comparator | Combination Product: VR only |
| Conventional physical therapy + lifestyle modification | Active comparator | Combination Product: Conventional physical therapy + lifestyle modification |
| Conventional physical therapy only | Active comparator | Combination Product: Conventional physical therapy only |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Female breast cancer survivors aged 30-60 years.
- Women with breast cancer who have undergone any type of breast cancer surgery (e.g., mastectomy, lumpectomy, or breast reconstruction), regardless of the specific surgical procedure will be included.
- Participants able to carry on upper limb and whole-body physical activity will be included.
- Participants able to use smart devices such as mobile phones and computers will be included.
- Patients obtaining a physician's clearance for fitness testing and exercise will be included.
Key exclusion criteria (8 listed)
- Subjects suffering from active malignant tumors or bilateral breast cancer.
- Participants disabling physical or psychological ailments not allowing them to participate in the intervention .
- Patients who had lymphedema will be excluded.
- Participants with visual disorders that interfered with a video game- based exercise.
- Subjects with cognitive disorders, mental disorders, or cooperation issues will be excluded.Subjects with vascular or cardiopulmonary disorders.
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 |
|---|---|---|
| VR + lifestyle modificationVR + lifestyle modification (Warm up,In VR kinetic sports I Bowling, Darts,Golf,Boxing,Beach Volleyball ,Table Tennis,Fruit Ninja)Passive glenohumeral joint mobilization,Scar tissue massage.In lifestyle modification walking at home for 30 min in 3-5 days /week. Dietry habits will be given according to American Institute for cancer Research. In sleep habits Recommended Sleep Hours 7-9 hours per night,Establish a Consistent Sleep Schedule,Create a Comfortable Sleep Environment,Limit Screen Time Before Bed,Engage in Relaxation Techniques,Limit Caffeine and Alcohol Intake,Manage Nighttime Discomfort,Maintain a Pre-Sleep Routine,Address Emotional Health,Avoid Daytime Naps.Deep breathing exercise for stress management | Combination product | VR + lifestyle modification |
| VR onlyVR only (Warm up,In VR kinetic sports I Bowling, Darts,Golf,Boxing,Beach Volleyball ,Table Tennis,Fruit Ninja)Passive glenohumeral joint mobilization,Scar tissue massage. | Combination product | VR only |
| Conventional physical therapy + lifestyle modificationConventional physical therapy + lifestyle modification In Conventional physical therapy(Pumping exercise for upper limb,Pendulum exercises ,Shrugs for shoulder and rotations,In sitting position arms up with clasped hands ,Shoulder rotation (arms on sides-arms in abduction),Arms up with hands clasped again but in lying position ,Wand exercises ,M. pectoralis major-M. Pectoralis Minor stretches in supine and standing positions,Snow angels,Front and lateral climbing on wall ,Trunk rotation in standing position (in sitting position, if not tolerated) | Combination product | Conventional physical therapy + lifestyle modification |
| Conventional physical therapy onlyConventional physical therapy only((Pumping exercise for upper limb,Pendulum exercises ,Shrugs for shoulder and rotations,In sitting position arms up with clasped hands ,Shoulder rotation (arms on sides-arms in abduction),Arms up with hands clasped again but in lying position ,Wand exercises ,M. pectoralis major-M. Pectoralis Minor stretches in supine and standing positions,Snow angels,Front and lateral climbing on wall ,Trunk rotation in standing position (in sitting position, if not tolerated) ,Trunk lateral flexion with arms in 90 degrees abduction in standing position,Theraband (flexion-extension-abduction, adduction and internal-external rotation),Muscles of upper limb strengthening ,Mobilization for passive glenohumeral joint ,Tissue massage for scars. | Combination product | Conventional physical therapy only |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 18 Months
Upper limb dysfunction can be assessed using a combination of pain evaluation, range of motion measurements, and muscle strength testing. Pain is typically recorded using the Visual Analog Scale (VAS), where the patient marks their perceived pain level along a 10-centimeter horizontal line, with 0 indicating no pain and 10 representing the worst imaginable pain.
Goniometer (shoulder flexion, abduction, external rotation)
Time frame: 18 Months
Scoring details: The score is determined by measuring the distance in centimeters from the 'no pain' end to the patient's mark. Range of motion (ROM) is assessed using a goniometer for key movements such as shoulder flexion, abduction, and external rotation. The angles achieved are measured in degrees and compared against established normative values typically 0° to 180° for flexion and abduction, and 0° to 90° for external rotation to identify limitations.
Handheld dynamometer
Time frame: 18 Months
Muscle strength is evaluated using a handheld dynamometer, measuring the force produced by muscle groups like shoulder flexors, abductors, and external rotators. Strength is recorded in kilograms or newtons, usually averaging three trials, and compared to normative data or the unaffected limb to determine the degree of weakness. Together, these measures provide a comprehensive functional profile of the upper limb.
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time frame: 18 Months
Functional outcomes for individuals with upper limb dysfunction can be evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, a widely used, standardized, self-reported measure. The DASH consists of 30 items that assess the patient's ability to perform various physical activities, severity of symptoms, and impact on social and work-related tasks involving the upper extremity. Each item is rated on a 5-point Likert scale, ranging from 1 (no difficulty or no symptoms) to 5 (unable to perform activity or extreme symptoms). The scores from all completed items are summed, averaged, and then transformed into a score out of 100, where 0 indicates no disability and 100 represents the most severe disability. This tool provides valuable insight into the patient's perceived functional status and the extent to which upper limb issues interfere with daily life and occupational tasks.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 18 Months
his is a validated, multidimensional, self-administered questionnaire designed to evaluate overall health-related quality of life in patients with chronic illness or undergoing treatment. The QLQ-C30 consists of 30 items covering several domains, including five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/quality of life scale, and several single-item assessments for additional symptoms such as insomnia, appetite loss, and financial difficulties. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much), except for the two global health status items, which use a 7-point scale. Scores are transformed to a scale from 0 to 100, with higher scores on the functional and global health scales indicating better functioning and quality of life, while higher scores on the symptom scales reflect greater symptom burden.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 18 Months
The HADS consists of 14 items, divided equally into two subscales: seven items assess symptoms of anxiety (HADS-A) and seven assess symptoms of depression (HADS-D). Each item is scored on a 4-point Likert scale ranging from 0 to 3, with total scores for each subscale ranging from 0 to 21. Scores are interpreted as follows: 0-7 indicates a normal range, 8-10 suggests possible anxiety or depression, and 11-21 indicates probable or clinically significant anxiety or depression.
Self-reported adherence to the lifestyle modification program through weekly logs.
Time frame: 18 Months
The Health-Promoting Lifestyle Profile II (HPLP-II) is scored using a 4-point Likert scale (Never, Sometimes, Often, Routinely) for each of its 52 items. The overall score is calculated as the mean of all item responses, and this mean score is then categorized into four levels: Poor, Moderate, Good, and Excellent. The collected data provides insight into patient engagement, consistency in following health recommendations, and potential barriers to adherence. Regular review of these weekly logs allows clinicians or researchers to track progress, identify patterns of non-compliance, and offer timely support or program adjustments to improve health behaviors and functional recovery outcomes.
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 2 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR + lifestyle modification, VR only and Conventional physical therapy + lifestyle modification in people with Breast Cancer, run by Superior University at 3 sites in Pakistan.
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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. 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?
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?
Visual Analog Scale (VAS) (time frame: 18 Months). The study lists 7 primary outcomes in all. 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 2 Feb 2026.