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Neck PainNCT06832748

Neck Movement Training in a Virtual Reality Headset for People with Neck Pain - a Feasibility Study

A study testing VR neck training and Endurance neck training in people with Neck Pain, run by Luleå Tekniska Universitet.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn if a virtual reality (VR) intervention for people with chronic neck pain is feasible. The main questions it aims to answer are: Is it possible to perform a future full-scale randomized controlled trial (RCT) with a remotely supervised VR-based intervention for people with… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Neck Pain
What is being tested?
VR neck training and Endurance neck training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Mar 2025to Jul 2025
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

  • Ability to understand verbal and written Swedish
  • Persistent neck pain (>3 months)
  • Neck pain onset (or acute worsening) in relation to trauma to the head or neck
  • Neck disability index 20-60% or Numeric Rating Scale neck pain ≥ 3/10
  • Impaired sensorimotor function of the neck (at least one of the sensorimotor tests must be impaired, i.e. below the norm values for the test in question). The following cut-off values are used:
  • Joint position sense test: > 4.5° absolute error in any of the four directions right rotation, left rotation, extension or flexion.
  • Movement sense test: >28 seconds to complete the zigzag pattern, or <2,5 norm value (i.e., accuracy in percentage divided by time in seconds).
  • Maximum velocity from the cervical reaction acuity test: < 100°/s. Range of motion in right rotation, left rotation, extension and flexion (added together): < 300°.

Who cannot join

  • Cervical radiculopathy
  • Neck surgery
  • Fracture of the neck
  • Neurological disease
  • Vestibular disease
  • Rheumatic disease
Show all 10Show fewer
  • Concussion where the person lost consciousness
  • Uncorrected visual impairment
  • Epilepsy
  • Previous experience of severe symptoms (nausea/dizziness) when using VR headsets

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Karin Forsberg, PhD student contact

+46 920 491358

karin.forsberg@ltu.se

Ulrik Röijezon, Professor contact

+46 920 492987

ulrik.roijezon@ltu.se

About this study

Official title: Feasibility of a Virtual Reality Based Sensorimotor Training Intervention for Patients with Chronic Traumatic Neck Pain

The goal of this clinical trial is to learn if a virtual reality (VR) intervention for people with chronic neck pain is feasible. The main questions it aims to answer are:

Is it possible to perform a future full-scale randomized controlled trial (RCT) with a remotely supervised VR-based intervention for people with chronic neck pain?

Read more

How do people with neck pain experience using VR in a home-based training intervention?

Researchers will investigate if aspects of a full-scale RCT is feasible. This includes how well the recruitment of participants worked, retention during the intervention, compliance to training program, adverse events, and experience using the VR during training. The study will also investigate initial indication of benefit of the VR intervention, such as effects on pain and function.

Participants will be randomly assigned to either a VR neck training group or an endurance training group. Both groups will perform a training program for 8 weeks with weekly follow ups with their physiotherapist via online meetings.

Read the detailed description

Title: Feasibility of a Virtual Reality-Based Sensorimotor Training Intervention for Patients with Chronic Traumatic Neck Pain

Background: Neck pain is very common, leading to reduced function and quality of life, and is costly for healthcare and society due to sick leave and productivity loss. The cause of neck pain is often unclear, with no visible structural damage. Persistent neck pain (lasting more than 3 months) and recurrent episodes are complex and not fully understood. Research suggests impaired sensorimotor control as a contributing factor.

Sensorimotor control involves neck movement control, awareness of head position, quick reaction to stimuli, and good neck mobility. These functions are crucial for daily activities (e.g., moving our body, riding a bike, driving a car), and maintaining body stability. Research has shown that these functions often are impaired in people with neck pain. Training these functions can reduce pain and improve function.

Virtual Reality (VR) technology, especially VR headsets, allows objective assessment of neck sensorimotor functions, crucial for personalized training to reduce pain and improve function. VR can measure movement velocity and reaction time, previously only possible with advanced lab equipment. VR can be used in clinics and at home, showing high accuracy in assessing neck functions. It may also make training enjoyable, potentially improving adherence.

Aim: This study aims to assess the feasibility of a future large-scale randomized controlled trial (RCT) using a VR-based training program for chronic neck pain patients. It will explore various feasibility aspects to plan a well-conducted RCT and examine participants' experiences with VR. Aspects include participant recruitment, adherence to intervention, study protocol feasibility, experience of VR based intervention, and initial effects on pain and function. Data will also help calculate the required sample size for a future RCT.

Method: The study is a pilot RCT with 20 participants randomized into two groups: VR training or endurance training. A stratified randomization to get equal number of women/men in each group will be performed through a randomization program. Both groups will train at home for 8 weeks with digital follow-ups from a physiotherapist.

There will be 2 qualified physiotherapists, each treating 10 patients (5 in each group). The physiotherapists have solid clinical experience from primary health care. They have experience treating people with neck pain and prescribing sensorimotor exercises. The physiotherapists will conduct baseline and post-treatment measures of outcome variables. They will not be blinded to treatment allocation.

Patients and physiotherapists will not be blinded to treatments due to the interventions being self-revealing.

After the intervention, VR group participants will be interviewed about their VR experience.

Participants: The study will include individuals with chronic neck pain (lasting more than 3 months) caused or worsened by trauma (e.g., car accidents, falls).

Outcome: The study will result in two publications: one on quantitative feasibility data, and another on qualitative feasibility data (patient interviews).

Conditions
Neck Pain
Being tested
VR neck training, Endurance neck training
Keywords
neck pain, virtual reality, VR, sensorimotor training, pilot RCT, endurance training, whiplash injuries, feasibility studies, randomized controlled trial
Medical subject headings
Neck Pain, Whiplash Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR neck trainingOther

    VR intervention 8 weeks. A VR headset is used for assessment and training of sensorimotor functions of the neck. The VR headset has a built-in sensor which can measure movements and give objective test and training results. The results serve as a guide for tailored home-based training programs, also performed with the VR headset in the experimental group. The participant performs the training at home, 15-20 minutes/day 5 days/week, initiallay divided into 3 sessions of 5 minutes each, while progression may lead to longer but fewer sessions. The program is individually tailored to target specific sensorimotor disturbances, and progressed during the intervention to increase the challenge. Participants will have video consultations with their physiotherapist once a week for the first 4 weeks, and every second week for the final 4 weeks. This can be adjusted to fit the participants needs. The VR is a novel technology, and this particular VR based training is not yet evaluated in research.

  • Endurance neck trainingOther

    An 8-week traditional endurance neck training intervention. The training program consists of neck and shoulder exercises performed with body weight, rubber bands, and free weights. The training is carried out at home, 15-20 minutes per day, 5 days a week. The training is individualized and progressed during the intervention. Participants will have video consultations with their physiotherapist once a week for the first 4 weeks, and then every second week for the final 4 weeks. This can be adjusted to fit the participants needs. This intervention is often used in the clinic and has been evaluated in several research studies with good results to reduce neck pain. However, its effects on sensorimotor functions have been less evaluated. Also, its effects compared to novel VR-training still needs to be evaluated.

Study groups in NCT06832748
Study groupRoleWhat they receive
VR neck training group (10 participants)Experimental10 participants will use a VR headsets and perform training targeting the neck sensorimotor function. The patient interacts through head movements, and perform tasks in the VR environment.
Receives: Other: VR neck training
Endurance neck training group (10 participants)Active comparator10 participants will perform endurance training for the neck and shoulder region, with body weight, rubber bands, and free weights.
Receives: Other: Endurance neck training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Recruitment time (weeks)

    Time taken to recruit 20 participants. This will be measured in number of weeks.

    Measured: From enrollment to end of treatment (at 8 weeks)

  2. Feasibility - Recruitment method

    Which recruitment channels were effective to find participants? (physiotherapy clinics, social media channels, newspaper advertisement, other). This will be measured by asking the participants.

    Measured: From enrollment to end of treatment (at 8 weeks)

  3. Feasibility - Adherence

    Adherence rate to interventions. For the VR training group this is evaluated from the VR online portal training log. For the endurance training group this is evaluated from training diaries. This will be measured by number of completed training sessions and presented as percentage of prescribed dosage. A minimum of 70 % completed training sessions is considered acceptable.

    Adherence feasibility criteria: ≥ 70% Proceed, 60-69% Proceed with changes, <60% Do not proceed

    Measured: Start of intervention to end of intervention at 8 weeks.

  4. Feasibility - Completion rate (drop out)

    Number of participants completing the intervention. Intervention completion rate feasibility criteria: ≥ 85% proceed, 70-85% proceed with changes, <70% do not proceed.

    Measured: Start of intervention to end of intervention at 8 weeks.

  5. Feasibility - Outcome measure completion rate

    Obtained outcome measures from participants completing the intervention. Outcome measure completion rate criteria: ≥ 85% Proceed, 70-85% Proceed with changes, <70% Do not proceed

    Measured: At 8 weeks

  6. Feasibility - Adverse events

    Number of adverse events and what character. Treating physiotherapists will record any adverse events during the intervention period.

    Measured: From start of intervention to 8 weeks

  7. Feasibility - Numeric Rating Scale (NRS) Simulator sickness intensity

    Sickness intensity measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their sickness intensity right after completion of the test protocol, from no sickness (0) to worst imaginable sickness (10).

    Measured: Baseline and at end of intervention (at 8 weeks).

  8. Feasibility - Participants experience using VR in neck training - Qualitative part

    Participants experience using VR in the 8-week intervention. This information will be obtained from semi-structured interviews, e.g., questions about usability, digitally delivered intervention, video consultations with physiotherapists, information and support, pros and cons of intervention.

    Measured: After completion of the 8 weeks VR-intervention, approximately within 2 weeks after completion.

Secondary outcomes (16)

  1. Cervical joint position sense (JPS) test (performed in the VR headset)

    Cervical JPS test assessed in the VR headset. The JPS test assesses the ability to sense the position of the neck and head (part of proprioception).

    With a dark VR screen (imitating being blindfolded), the task is to find neutral head position, perform a head movement, and reposition the head back to the neutral position as accurately as possible. The test is performed with 6 repetitions i right rotation, left rotation, extension and flexion respectively. The error from starting position to end position is measured in degrees. Absolute error is calculated as outcome measure.

    Measured: Baseline and at end of intervention (at 8 weeks)

  2. Cervical reaction acuity (CRA) test - Reaction time milliseconds (performed in the VR headset)

    CRA test assessed in the VR headset. A ball on the VR screen will move from the center to a random location. The task is to follow the ball as quickly as possible by moving the head to the center of the ball and staying in the center until a time circle counts down. The ball appears in the middle again, the participant moves their head back there and the next attempt begins. This will be repeated in random directions for 8 repetitions. Reaction time is measured in milliseconds, and defined as the time from the movement of the ball to the participant reaching 5% of their maximum velocity.

    Measured: Baseline and at end of intervention (at 8 weeks)

  3. Cervical reaction acuity (CRA) test - Maximum velocity. (performed in the VR headset)

    CRA test assessed in the VR headset. A ball on the VR screen will move from the center to a random location. The task is to follow the ball as quickly as possible by moving the head to the center of the ball and staying in the center until a time circle counts down. The ball appears in the middle again, the participant moves their head back there and the next attempt begins. This will be repeated in random directions for 8 repetitions. Maximum velocity per repetition is measured in degrees per seconds.

    Measured: Baseline and at end of intervention (at 8 weeks)

  4. Cervical reaction acuity (CRA) test - Time to complete the task. (performed in the VR headset)

    CRA test assessed in the VR headset. A ball on the VR screen will move from the center to a random location. The task is to follow the ball as quickly as possible by moving the head to the center of the ball and staying in the center until a time circle counts down. The ball appears in the middle again, the participant moves their head back there and the next attempt begins. This will be repeated in random directions for 8 repetitions. Time to complete the task is measured in seconds.

    Measured: Baseline and at end of intervention (at 8 weeks)

  5. Cervical movement sense test (performed in the VR headset)

    Cervical movement sense test assessed in the VR headset. With head movements, participant trace the lines of a zig zag pattern as accurately as possible to their self-chosen speed. Outcome measures are:

    • Accuracy in percentage representing the percentage of the time being on the line.
    • Time to complete the task.
    • Norm value (accuracy divided by time).

    Measured: Baseline and at end of intervention (at 8 weeks)

  6. Cervical range of motion test (performed in the VR headset)

    Maximum cervical range of motion in degrees is assessed in the VR headset for

    • right rotation
    • left rotation
    • extension
    • flexion
    • right lateral flexion
    • left lateral flexion
    • right diagonal extension
    • left diagonal extension
    • right diagonal flexion
    • left diagonal flexion

    Measured: Baseline and at end of intervention (at 8 weeks)

  7. Postural sway in quiet stance (performed with the VR headset)

    Postural sway assessed in the VR headset. Quiet stance with feet together and arms crossed over the chest. The task is to stand as still as possible for 30 seconds with eyes open and closed, respectively. Outcome measures are the total length of the sway path in cm and sway amplitude in cm in anterio-posterior and medio-lateral direction, respectively. Data will be normalized to the height of the person.

    Measured: Baseline and at end of intervention (at 8 weeks)

  8. Cervical flexion endurance test

    The participant lies in supine position, legs bent to 90 degrees. The chin is flexed while lifting the head and neck to about 2.5 cm above the surface. The test leader places one hand on the surface just below the participant's occiput to feel when the participant loses lift.

    The test ends if the participant touches the test leader's hand for more than one second or if the participant loses the flexion of the chin.

    Outcome measures are seconds.

    Measured: Baseline and at end of intervention (at 8 weeks)

  9. Neck Disability Index (NDI)

    A self-reported physical functioning questionnaire targeting pain intensity and how it interferes with daily activities. Maximum score is 50 where a higher score represents higher disability. The score is transformed to percentage, higher percentage representing higher disability.

    Measured: Baseline and at end of intervention (at 8 weeks)

  10. Numeric Rating Scale (NRS) neck pain

    Pain intensity measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their average pain intensity the previous 7 days, from no pain (0) to worst imaginable pain (10).

    Measured: Baseline and at end of intervention (at 8 weeks)

  11. Numeric Rating Scale (NRS) dizziness

    Dizziness intensity will be measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their average dizziness intensity the previous 7 days from 0=no dizziness to 10= worst imaginable dizziness.

    Measured: Baseline and at end of intervention (at 8 weeks)

  12. Numeric Rating Scale (NRS) headache

    Headache intensity will be measured by the eleven-point Numeric Rating Scale (NRS), 0-10. The participants rate their average headache intensity the previous 7 days from 0=no headache to 10=worst imaginable headache.

    Measured: Baseline and at end of intervention (at 8 weeks)

  13. EQ-5D-5L

    Euro Quality of life 5 Dimensions 5 Levels (EQ-5D-5L). This is a questionnaire measuring health related quality of life. It is made up of 5 questions concerning mobility, personal care, daily activities, pain and discomfort, and psychological function (anxiety/depression). Each question gives a score from 1-5 where 1 = no problem and 5 = major problems and gives a 5-digit score which relates to a health profile.

    Measured: Baseline and at end of intervention (at 8 weeks)

  14. Tampa scale of kinesiophobia -short version 11 item (TSK-11)

    Fear of movement questionnaire. It consists of 11 items, 1-4-point scale, where a higher score represents higher fear of movement.

    Measured: Baseline and at end of intervention (at 8 weeks)

  15. Global perceived effect (GPE)

    The global perceived effect scale is used to measure how much the participants neck problem has changed since the start of the intervention. It is an 11-point scale where -5=Much worse 0=No change, and +5=Much better

    Measured: At end of intervention (at 8 weeks)

  16. Feasibility - Physiotherapists experience of the VR intervention- Measured with a questionnaire.

    Treating physiotherapists' experience of carrying out the VR intervention is evaluated with a questionnaire. It contains questions targeting aspects of the VR intervention, such as delivering the intervention remotely, advantages and disadvantages compared to traditional treatment with patient visits at a clinic, and usability aspects. The questionnaire comprises of nine 9-point Likert-scale questions, where 1 represents "strongly disagree" and 9 represents "strongly agree". Higher number indicate a more positive rating. Two open questions are included for comments about pros and cons of the VR-technology.

    Measured: After all participants have completed post intervention assessments at the end of the intervention (at 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2025
  2. Study startMar 2025 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

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 is a feasibility study and pilot randomized controlled trial (RCT). The study will gain knowledge of feasibility of the intervention before a future full scale RCT. The study has a quantitative part to assess the feasibility of the VR-intervention, and to obtain initial measures of possible intervention effects for future sample size calculation when compared to a more traditional rehab intervention. It has also a qualitative part including interviews with the participants in the VR-group.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06832748
Sponsor's protocol ID
EPM Dnr 2024-07490-01
Other IDs
CIV 24-08-048898
Status last verified
Feb 2025
First submitted
31 Jan 2025
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to sensitive data (health data) being collected.

Publications

  • GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.

    PubMed 28919117

  • Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. doi: 10.1016/j.math.2007.06.003. Epub 2007 Aug 16.

    PubMed 17702636

  • Safiri S, Kolahi AA, Hoy D, Buchbinder R, Mansournia MA, Bettampadi D, Ashrafi-Asgarabad A, Almasi-Hashiani A, Smith E, Sepidarkish M, Cross M, Qorbani M, Moradi-Lakeh M, Woolf AD, March L, Collins G, Ferreira ML. Global, regional, and national burden of neck pain in the general population, 1990-2017: systematic analysis of the Global Burden of Disease Study 2017. BMJ. 2020 Mar 26;368:m791. doi: 10.1136/bmj.m791.

    PubMed 32217608

  • Sjolander P, Michaelson P, Jaric S, Djupsjobacka M. Sensorimotor disturbances in chronic neck pain--range of motion, peak velocity, smoothness of movement, and repositioning acuity. Man Ther. 2008 May;13(2):122-31. doi: 10.1016/j.math.2006.10.002. Epub 2007 Jan 2.

    PubMed 17197230

  • Sarig Bahat H, Croft K, Carter C, Hoddinott A, Sprecher E, Treleaven J. Remote kinematic training for patients with chronic neck pain: a randomised controlled trial. Eur Spine J. 2018 Jun;27(6):1309-1323. doi: 10.1007/s00586-017-5323-0. Epub 2017 Oct 10.

    PubMed 29018956

  • Sarig Bahat H, Chen X, Reznik D, Kodesh E, Treleaven J. Interactive cervical motion kinematics: sensitivity, specificity and clinically significant values for identifying kinematic impairments in patients with chronic neck pain. Man Ther. 2015 Apr;20(2):295-302. doi: 10.1016/j.math.2014.10.002. Epub 2014 Oct 14.

    PubMed 25456272

  • Roijezon U, Djupsjobacka M, Bjorklund M, Hager-Ross C, Grip H, Liebermann DG. Kinematics of fast cervical rotations in persons with chronic neck pain: a cross-sectional and reliability study. BMC Musculoskelet Disord. 2010 Sep 27;11:222. doi: 10.1186/1471-2474-11-222.

    PubMed 20875135

  • Roijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29.

    PubMed 25703454

  • Qu N, Tian H, De Martino E, Zhang B. Neck Pain: Do We Know Enough About the Sensorimotor Control System? Front Comput Neurosci. 2022 Jul 15;16:946514. doi: 10.3389/fncom.2022.946514. eCollection 2022.

    PubMed 35910451

  • Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12.

    PubMed 33464539

  • Jull G, Falla D, Treleaven J, Hodges P, Vicenzino B. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. 2007 Mar;25(3):404-12. doi: 10.1002/jor.20220.

    PubMed 17143898

  • Moghaddas D, de Zoete RMJ, Edwards S, Snodgrass SJ. Differences in the kinematics of the cervical and thoracic spine during functional movement in individuals with or without chronic neck pain: a systematic review. Physiotherapy. 2019 Dec;105(4):421-433. doi: 10.1016/j.physio.2019.01.007. Epub 2019 Jan 21.

    PubMed 31005251

  • Malfliet A, Kregel J, Cagnie B, Kuipers M, Dolphens M, Roussel N, Meeus M, Danneels L, Bramer WM, Nijs J. Lack of evidence for central sensitization in idiopathic, non-traumatic neck pain: a systematic review. Pain Physician. 2015 May-Jun;18(3):223-36.

    PubMed 26000666

  • Kristjansson E, Treleaven J. Sensorimotor function and dizziness in neck pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):364-77. doi: 10.2519/jospt.2009.2834.

    PubMed 19411769

  • Kristjansson E, Bjornsdottir SV, Oddsdottir GL. The long-term course of deficient cervical kinaesthesia following a whiplash injury has a tendency to seek a physiological homeostasis. A prospective study. Man Ther. 2016 Apr;22:196-201. doi: 10.1016/j.math.2015.12.008. Epub 2015 Dec 23.

    PubMed 26778601

Questions about this trial

What is this clinical trial studying?

A study testing VR neck training and Endurance neck training in people with Neck Pain, run by Luleå Tekniska Universitet.

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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Karin Forsberg, PhD student (+46 920 491358, karin.forsberg@ltu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Recruitment time (weeks) (time frame: From enrollment to end of treatment (at 8 weeks)). The study lists 8 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 NCT06832748, which also lists 21 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 18 Feb 2025.

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