Lumbar Disc HerniationNCT07204197
Effectiveness of Virtual Reality-Assisted Physical Therapy in the Acute Phase After Lumbar Disc Surgery
A study testing Virtual Reality-Assisted Physical Therapy and Conventional Physical Therapy in people with Lumbar Disc Herniation and Lumbar Disc Surgery, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of virtual reality-assisted physical therapy in the acute postoperative period after lumbar disc surgery. The main questions it aims to answer are: Does virtual reality-assisted physical therapy reduce pain more effectively than conventional physical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Disc Surgery
- What is being tested?
- Virtual Reality-Assisted Physical Therapy and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 17 Jul 2025to 16 Sep 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Undergoing lumbar discectomy surgery (L4-L5 or L5-S1 levels).
- Able to start postoperative physical therapy on day 1 after surgery.
- Willing and able to provide informed consent.
- Sufficient cognitive and physical ability to participate in physical therapy and virtual reality sessions.
Who cannot join
- History of previous lumbar spine surgery.
- Severe neurological deficits (e.g., cauda equina syndrome, progressive motor weakness).
- Diagnosed epilepsy, severe psychiatric illness, or other conditions contraindicate VR use.
- Significant visual or vestibular impairments preventing safe VR participation.
- Uncontrolled systemic diseases (e.g., cardiovascular, respiratory, or metabolic instability).
- Pregnancy.
- Inability to understand study instructions or complete outcome assessments.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Ankara, 06000
Hacettepe University Hospital Neurosurgery Department
Ankara, Ankara, 06000
About this study
Official title: Investigation of the Effectiveness of Virtual Reality-Assisted Physical Therapy in the Acute Period After Lumbar Disc Surgery
The goal of this clinical trial is to evaluate the effectiveness of virtual reality-assisted physical therapy in the acute postoperative period after lumbar disc surgery.
The main questions it aims to answer are:
Read more
- Does virtual reality-assisted physical therapy reduce pain more effectively than conventional physical therapy?
- Does it improve functional recovery, pain threshold, and blood biomediator levels?
- Does it reduce anxiety and kinesiophobia in the early rehabilitation period?
Researchers will compare virtual reality-assisted physical therapy with standard physical therapy to determine whether virtual reality provides additional therapeutic benefits.
Participants will:
- Undergo standard postoperative physical therapy after lumbar disc surgery.
- Some participants will additionally perform virtual reality-based rehabilitation exercises.
- Be evaluated for pain severity, functional improvement, blood biomediators, pain threshold, and psychological outcomes.
Read the detailed description
Lumbar disc herniation (LDH) is one of the most common musculoskeletal disorders and a major cause of low back pain worldwide. It occurs when the intervertebral disc extends beyond its anatomical boundaries, compressing neural structures and leading to pain, disability, and reduced quality of life. Although most patients are treated conservatively, approximately 15% require surgical intervention. Postoperative pain is one of the most significant challenges after lumbar disc surgery, reported in up to 70% of patients in the acute period. Insufficient pain management may delay mobilization, prolong hospitalization, increase healthcare costs, and negatively affect both physical and psychological recovery.
Pharmacological treatments, such as NSAIDs, opioids, muscle relaxants, and neuropathic pain agents, are commonly used for postoperative pain control. However, their potential side effects and limited efficacy have raised interest in non-pharmacological interventions. Conventional physical therapy protocols-mobilization, exercise, manual therapy, and patient education-are central to postoperative rehabilitation, improving mobility, functional recovery, and independence. Early mobilization within the first days after surgery has been shown to reduce complications and accelerate healing.
In recent years, technology-based approaches have emerged as complementary or alternative rehabilitation methods. Among them, virtual reality (VR) offers interactive, multisensory, and engaging environments that can contribute to both physical and psychological recovery. VR has shown therapeutic potential in pain management by diverting attention, reducing anxiety and stress, and promoting patient engagement in rehabilitation. Importantly, VR has demonstrated effectiveness in musculoskeletal conditions, neurological rehabilitation, and postoperative care in other surgical populations.
Despite growing evidence, there is a lack of comprehensive studies evaluating VR in the acute postoperative phase after lumbar disc surgery, particularly in comparison with conventional physical therapy protocols. This study aims to address this gap by investigating the effectiveness of VR-assisted physical therapy versus conventional physical therapy in patients undergoing lumbar discectomy.
The primary outcomes include pain intensity, pain threshold, and blood biomediator levels. Secondary outcomes include functional recovery, kinesiophobia, and anxiety. By systematically comparing both interventions, this trial seeks to determine the advantages and limitations of VR-assisted rehabilitation, with the goal of developing innovative, safe, and effective strategies for postoperative care.
- Conditions
- Lumbar Disc Herniation, Lumbar Disc Surgery
- Being tested
- Virtual Reality-Assisted Physical Therapy, Conventional Physical Therapy
- Keywords
- lumbar disc herniation, lumbar disc surgery, physiotherapy and rehabilitation, virtual reality, pain, functional capacity, psychosomatic status
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Assisted Physical TherapyOther
Also called Conventional Physical Therapy
VR Assisted PT intervention, combines a standardized postoperative physical therapy program with an additional 20-minute immersive VR session. The VR component is relaxation-focused and interactive, making the total session length 60 minutes. The distinguishing feature is the integration of VR technology into early rehabilitation after lumbar disc surgery, which is not part of conventional therapy.
Conventional Physical TherapyOther
This intervention consists of the same standardized physical therapy program as the VR group, delivered for 60 minutes daily by increasing exercise repetitions and intensity. The distinguishing feature is that it does not include any VR component, allowing direct comparison of physical therapy alone versus VR-assisted therapy.
| Study group | Role | What they receive |
|---|---|---|
| Virtual-Reality-Assisted Physical Therapy Group | Experimental | Participants assigned to this group will receive a standardized 40-minute physical therapy program starting on postoperative day 1, followed by a 20-minute immersive virtual reality (VR) session. The VR application provides a relaxation-focused, interactive environment designed to reduce pain perception, anxiety, and stress while supporting engagement in rehabilitation. Sessions are delivered once daily during hospitalization. Patients are monitored for comfort and potential side effects such as dizziness or nausea, and all procedures are supervised by a physiotherapist to ensure safety and adherence. Receives: Other: Virtual Reality-Assisted Physical Therapy |
| Conventional Physical Therapy Group | Active comparator | Participants in this group will receive the same standardized physical therapy program as the VR group, beginning on postoperative day 1. To match the 60-minute session length, exercise repetitions and intensity are increased instead of adding virtual reality. Thus, both groups complete identical physical therapy content, with the only difference being the addition of a VR session in the intervention group. All sessions are delivered once daily during hospitalization and supervised by a physiotherapist. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS)
Pain severity will be assessed using a 10 cm Visual Analog Scale (VAS), where participants mark their perceived pain level ranging from 0 (no pain) to 10 (worst imaginable pain). Both resting pain and pain during the most difficult daily activity will be recorded.
Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Pain Pressure Threshold (Algometry)
Pressure pain thresholds will be measured using an algometer applied to quadratus lumborum, tibialis anterior, and iliopsoas muscles. This method provides an objective evaluation of pain sensitivity in targeted muscle groups.
Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Blood Biomediators (CRP, Cortisol, Leukocyte Count)
Blood samples will be collected to analyze inflammatory and stress-related biomarkers associated with postoperative pain. Routine venous blood collection (8-10 cc) will be performed, and analyses will be conducted in a central laboratory.
Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Secondary outcomes (6)
Functional Capacity (Timed Up and Go Test)
Participants will be asked to rise from a chair, walk 3 meters, turn around, walk back, and sit down. The total time will be recorded in seconds as an indicator of mobility and functional performance.
Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Functional Capacity (10-Meter Walk Test)
Participants will walk a 10-meter distance at a comfortable but fast pace. The time will be recorded, and gait speed will be calculated.
Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Kinesiophobia (Tampa Scale of Kinesiophobia)
Fear of movement and reinjury will be measured using the validated Turkish version of the 17-item Tampa Scale of Kinesiophobia. Higher scores indicate greater movement-related fear.
Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS)
Psychological status will be evaluated with the Hospital Anxiety and Depression Scale, which includes separate subscales for anxiety (HADS-A) and depression (HADS-D).
Measured: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Treatment Satisfaction (Global Perceived Effect, GPE Scale)
Participants will rate their overall improvement after the intervention compared to their pre-treatment condition on a 7-point Likert scale, ranging from "completely recovered" to "worse than ever."
Measured: Post-operative day 2 (after intervention completion).
Virtual Reality Sickness Questionnaire (VRSQ) (VR group only)
Presence and severity of VR-related symptoms such as dizziness, nausea, or visual discomfort will be assessed using the validated Turkish version of the Virtual Reality Sickness Questionnaire.
Measured: Immediately before and after each VR session, approximately 30 minutes apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start17 Jul 2025
- Primary completion16 Sep 2027 (estimated)
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized, controlled, parallel-group design. Participants undergoing lumbar disc surgery will be randomly assigned to one of two groups: (1) Virtual Reality-Assisted Physical Therapy or (2) Conventional Physical Therapy. Both groups will receive interventions starting from postoperative day 1, until the day of discharge and outcomes will be compared between the two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE ÇETİN, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204197
- Sponsor's protocol ID
- VRLDHS1D
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of patient privacy and confidentiality concerns.
Publications
Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, Meziat-Filho N. Effectiveness of Cognitive Functional Therapy Versus Core Exercises and Manual Therapy in Patients With Chronic Low Back Pain After Spinal Surgery: Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105.
PubMed 37548608He W, Wang Q, Hu J, Lin S, Zhang K, Wang F, Xu C, Li F, Xiao J, Li X, Tang F. A randomized trial on the application of a nurse-led early rehabilitation program after minimally invasive lumbar internal fixation. Ann Palliat Med. 2021 Sep;10(9):9820-9829. doi: 10.21037/apm-21-2294.
PubMed 34628908
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Virtual Reality-Assisted Physical Therapy in the Acute Period After Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT07204197
- Acronym / sponsor ID
- VRLDHS1D
- Conditions
- Lumbar Disc Herniation, Lumbar Disc Surgery
- Keywords
- lumbar disc herniation, lumbar disc surgery, physiotherapy and rehabilitation, virtual reality, pain, functional capacity, psychosomatic status
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 2 Oct 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 goal of this clinical trial is to evaluate the effectiveness of virtual reality-assisted physical therapy in the acute postoperative period after lumbar disc surgery.
The main questions it aims to answer are:
- Does virtual reality-assisted physical therapy reduce pain more effectively than conventional physical therapy?
- Does it improve functional recovery, pain threshold, and blood biomediator levels?
- Does it reduce anxiety and kinesiophobia in the early rehabilitation period?
Researchers will compare virtual reality-assisted physical therapy with standard physical therapy to determine whether virtual reality provides additional therapeutic benefits.
Participants will:
- Undergo standard postoperative physical therapy after lumbar disc surgery.
- Some participants will additionally perform virtual reality-based rehabilitation exercises.
- Be evaluated for pain severity, functional improvement, blood biomediators, pain threshold, and psychological outcomes.
Detailed description
Lumbar disc herniation (LDH) is one of the most common musculoskeletal disorders and a major cause of low back pain worldwide. It occurs when the intervertebral disc extends beyond its anatomical boundaries, compressing neural structures and leading to pain, disability, and reduced quality of life. Although most patients are treated conservatively, approximately 15% require surgical intervention. Postoperative pain is one of the most significant challenges after lumbar disc surgery, reported in up to 70% of patients in the acute period. Insufficient pain management may delay mobilization, prolong hospitalization, increase healthcare costs, and negatively affect both physical and psychological recovery.
Pharmacological treatments, such as NSAIDs, opioids, muscle relaxants, and neuropathic pain agents, are commonly used for postoperative pain control. However, their potential side effects and limited efficacy have raised interest in non-pharmacological interventions. Conventional physical therapy protocols-mobilization, exercise, manual therapy, and patient education-are central to postoperative rehabilitation, improving mobility, functional recovery, and independence. Early mobilization within the first days after surgery has been shown to reduce complications and accelerate healing.
In recent years, technology-based approaches have emerged as complementary or alternative rehabilitation methods. Among them, virtual reality (VR) offers interactive, multisensory, and engaging environments that can contribute to both physical and psychological recovery. VR has shown therapeutic potential in pain management by diverting attention, reducing anxiety and stress, and promoting patient engagement in rehabilitation. Importantly, VR has demonstrated effectiveness in musculoskeletal conditions, neurological rehabilitation, and postoperative care in other surgical populations.
Despite growing evidence, there is a lack of comprehensive studies evaluating VR in the acute postoperative phase after lumbar disc surgery, particularly in comparison with conventional physical therapy protocols. This study aims to address this gap by investigating the effectiveness of VR-assisted physical therapy versus conventional physical therapy in patients undergoing lumbar discectomy.
The primary outcomes include pain intensity, pain threshold, and blood biomediator levels. Secondary outcomes include functional recovery, kinesiophobia, and anxiety. By systematically comparing both interventions, this trial seeks to determine the advantages and limitations of VR-assisted rehabilitation, with the goal of developing innovative, safe, and effective strategies for postoperative care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study uses a randomized, controlled, parallel-group design. Participants undergoing lumbar disc surgery will be randomly assigned to one of two groups: (1) Virtual Reality-Assisted Physical Therapy or (2) Conventional Physical Therapy. Both groups will receive interventions starting from postoperative day 1, until the day of discharge and outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Virtual-Reality-Assisted Physical Therapy Group | Experimental | Other: Virtual Reality-Assisted Physical TherapyParticipants assigned to this group will receive a standardized 40-minute physical therapy program starting on postoperative day 1, followed by a 20-minute immersive virtual reality (VR) session. The VR application provides a relaxation-focused, interactive environment designed to reduce pain perception, anxiety, and stress while supporting engagement in rehabilitation. Sessions are delivered once daily during hospitalization. Patients are monitored for comfort and potential side effects such as dizziness or nausea, and all procedures are supervised by a physiotherapist to ensure safety and adherence. |
| Conventional Physical Therapy Group | Active comparator | Other: Conventional Physical TherapyParticipants in this group will receive the same standardized physical therapy program as the VR group, beginning on postoperative day 1. To match the 60-minute session length, exercise repetitions and intensity are increased instead of adding virtual reality. Thus, both groups complete identical physical therapy content, with the only difference being the addition of a VR session in the intervention group. All sessions are delivered once daily during hospitalization and supervised by a physiotherapist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years.
- Undergoing lumbar discectomy surgery (L4-L5 or L5-S1 levels).
- Able to start postoperative physical therapy on day 1 after surgery.
- Willing and able to provide informed consent.
- Sufficient cognitive and physical ability to participate in physical therapy and virtual reality sessions.
Key exclusion criteria (7 listed)
- History of previous lumbar spine surgery.
- Severe neurological deficits (e.g., cauda equina syndrome, progressive motor weakness).
- Diagnosed epilepsy, severe psychiatric illness, or other conditions contraindicate VR use.
- Significant visual or vestibular impairments preventing safe VR participation.
- Uncontrolled systemic diseases (e.g., cardiovascular, respiratory, or metabolic instability).
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 |
|---|---|---|
| Virtual Reality-Assisted Physical TherapyAlso: Conventional Physical TherapyVR Assisted PT intervention, combines a standardized postoperative physical therapy program with an additional 20-minute immersive VR session. The VR component is relaxation-focused and interactive, making the total session length 60 minutes. The distinguishing feature is the integration of VR technology into early rehabilitation after lumbar disc surgery, which is not part of conventional therapy. | Other | Virtual-Reality-Assisted Physical Therapy Group |
| Conventional Physical TherapyThis intervention consists of the same standardized physical therapy program as the VR group, delivered for 60 minutes daily by increasing exercise repetitions and intensity. The distinguishing feature is that it does not include any VR component, allowing direct comparison of physical therapy alone versus VR-assisted therapy. | Other | Conventional Physical Therapy Group |
Primary outcome
Pain Intensity (VAS)
Time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Pain severity will be assessed using a 10 cm Visual Analog Scale (VAS), where participants mark their perceived pain level ranging from 0 (no pain) to 10 (worst imaginable pain). Both resting pain and pain during the most difficult daily activity will be recorded.
Pain Pressure Threshold (Algometry)
Time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Pressure pain thresholds will be measured using an algometer applied to quadratus lumborum, tibialis anterior, and iliopsoas muscles. This method provides an objective evaluation of pain sensitivity in targeted muscle groups.
Blood Biomediators (CRP, Cortisol, Leukocyte Count)
Time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Blood samples will be collected to analyze inflammatory and stress-related biomarkers associated with postoperative pain. Routine venous blood collection (8-10 cc) will be performed, and analyses will be conducted in a central laboratory.
6 secondary outcomes
Functional Capacity (Timed Up and Go Test)
Time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Functional Capacity (10-Meter Walk Test)
Time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Kinesiophobia (Tampa Scale of Kinesiophobia)
Time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS)
Time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).
Treatment Satisfaction (Global Perceived Effect, GPE Scale)
Time frame: Post-operative day 2 (after intervention completion).
Virtual Reality Sickness Questionnaire (VRSQ) (VR group only)
Time frame: Immediately before and after each VR session, approximately 30 minutes apart.
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 Oct 2025.
- Background: PubMed 37548608Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, Meziat-Filho N. Effectiveness of Cognitive Functional Therapy Versus Core Exercises and Manual Therapy in Patients With Chronic Low Back Pain After Spinal Surgery: Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105.
- Background: PubMed 34628908He W, Wang Q, Hu J, Lin S, Zhang K, Wang F, Xu C, Li F, Xiao J, Li X, Tang F. A randomized trial on the application of a nurse-led early rehabilitation program after minimally invasive lumbar internal fixation. Ann Palliat Med. 2021 Sep;10(9):9820-9829. doi: 10.21037/apm-21-2294.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of patient privacy and confidentiality concerns.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Assisted Physical Therapy and Conventional Physical Therapy in people with Lumbar Disc Herniation and Lumbar Disc Surgery, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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 5 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Pain Intensity (VAS) (time frame: Baseline (Postoperative Day 1, before intervention) and at postoperative day 2 (upon completion of the intervention).). The study lists 3 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 NCT07204197, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.