Chronic Back and Leg PainNCT07492784
Investigation of the Effect of a Virtual Reality-Based Back School Program on Pain, Functionality, and Kinesiophobia
A study testing Back school education integrated with a VR headset in people with Chronic Back and Leg Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of a 4-week virtual reality (VR)-based back school program on pain, disability, fear of movement, and lumbar joint position sense (JPS) in individuals with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Back and Leg Pain
- What is being tested?
- Back school education integrated with a VR headset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Presence of chronic low back pain for at least three months
- A resting pain intensity of 3 to 7 on the Visual Analog Scale (VAS)
- The cognitive ability to follow physiotherapy instructions
- Any physical therapy program within the previous 6 months
Who cannot join
- Neurological deficits
- Vestibular pathologies
- Major trauma
- Active infections
- Tumors,
- Inflammatory diseases
- They declined to participate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yozgat Bozok University
Yozgat, Sarıkaya, 66650
About this study
This study investigates the effects of a 4-week virtual reality (VR)-based back school program on pain, disability, fear of movement, and lumbar joint position sense (JPS) in individuals with chronic low back pain. Thirty-nine participants are allocated to either a VR-based back school group or a conventional back school group. Both groups perform supervised low back exercises. Pain, disability, proprioception, kinesiophobia, and perceived cognitive deficits are assessed before and after the intervention.
Read the detailed description
Background and Aim:
Chronic low back pain (CLBP) is a multidimensional condition associated with functional limitations, fear of movement, and proprioceptive impairments. Contemporary rehabilitation approaches, such as back school programs, are based on a biopsychosocial model and aim to enhance patient engagement. Virtual reality (VR) applications may further support these interventions by increasing motivation and providing enriched sensory feedback. This study aims to investigate the effects of a 4-week VR-based back school program on pain, disability, fear of movement, and joint position sense (JPS) in individuals with CLBP.
Methods:
The study includes 39 participants allocated into an experimental group (n=20) and a control group (n=19). The control group receives back school training through verbal instruction delivered by a physiotherapist, while the experimental group receives the same training integrated with a VR headset. Following the education sessions, both groups perform standard low back exercises under physiotherapist supervision.
Outcome measures include:
Pain intensity assessed using the Visual Analog Scale (VAS)
Disability assessed using the Oswestry Disability Index (ODI)
Lumbar joint position sense measured using a goniometric method
Fear of movement assessed using the Tampa Scale for Kinesiophobia (TSK)
Cognitive function assessed using the Perceived Deficits Questionnaire (PDQ)
All outcomes are evaluated before and after the 4-week intervention period.
- Conditions
- Chronic Back and Leg Pain
- Being tested
- Back school education integrated with a VR headset
- Keywords
- Back school, exercise, pain, physiotherapy, virtual reality
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back school education integrated with a VR headsetOther
Also called Low back pain exercises
The intervention lasted for 4 weeks, comprising 2 sessions per week (8 sessions in total). Following baseline assessments, participants were randomly allocated to either the experimental or control group based on their resting pain levels. The experimental group received back school education integrated with a VR headset, whereas the control group received the standard back school education via verbal instruction from a physiotherapist. Following the education sessions, both groups performed supervised conventional low back exercises. The intervention was progressively structured over the 4-week period. Exercises were individualized according to each patient's clinical status and tolerance, following the principle of progressive overload, while strictly avoiding pain provocation.
| Study group | Role | What they receive |
|---|---|---|
| Pain intensity | Experimental | In this scale, the starting point is defined as "0 = no pain" and the end point as "10 = unbearable pain." Participants were asked to mark their current pain levels on this line. Pain levels were assessed separately at rest, during activity, and at night. Receives: Other: Back school education integrated with a VR headset |
| Lumbar joint position sense | Experimental | Participants were comfortably positioned, and the assessor passively moved their lumbar spine into a specific angle of flexion or extension. After holding the target angle for 3 seconds to allow proprioceptive encoding, participants were asked to actively replicate the position. The absolute error between the passively given angle and the actively replicated angle was recorded in degrees. Receives: Other: Back school education integrated with a VR headset |
| Tampa Scale for Kinesiophobia | Experimental | This 17-item questionnaire utilizes a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree) to evaluate kinesiophobia and movement avoidance following an injury. After reverse-scoring items 4, 8, 12, and 16, a total score ranging from 17 to 68 is calculated, with higher scores indicating greater kinesiophobia. Receives: Other: Back school education integrated with a VR headset |
| Functional disability | Experimental | Functional disability was measured with the Oswestry Disability Index (ODI) (17, 18). The ODI consists of 10 sections related to daily living activities such as personal care, lifting, walking, sitting, standing, and sleeping. Each section is scored from 0 to 5. The total score ranges from 0 to 50, categorized as no disability (0-4), mild (5-14), moderate (15-24), severe (25-34), and complete disability (35-50). Receives: Other: Back school education integrated with a VR headset |
| Perceived Deficits Questionnaire | Experimental | Subjective cognitive function was evaluated using the Perceived Deficits Questionnaire (PDQ) developed by Sullivan et al. (19). This 20-item scale assesses different domains of cognitive function, including attention/concentration, retrospective memory, prospective memory, and planning/organization. It is scored on a 5-point Likert-type scale (0 = never, 4 = almost always). Total scores range from 0 to 80, with higher scores reflecting greater perceived cognitive impairment over the past four weeks. Receives: Other: Back school education integrated with a VR headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity was evaluated using a 10-cm VAS developed by Price et al. In this scale, the starting point is defined as "0 = no pain" and the end point as "10 = unbearable pain." Participants were asked to mark their current pain levels on this line. Pain levels were assessed separately at rest, during activity, and at night.
Measured: At baseline and immediately post-intervention (4 weeks)
Lumbar joint position sense
Lumbar joint position sense (JPS) was evaluated using a goniometric measurement method. Participants were comfortably positioned, and the assessor passively moved their lumbar spine into a specific angle of flexion or extension. After holding the target angle for 3 seconds to allow proprioceptive encoding, participants were asked to actively replicate the position. The absolute error between the passively given angle and the actively replicated angle was recorded in degrees.
Measured: At baseline and immediately post-intervention (4 weeks)
Tampa Scale for Kinesiophobia
Fear of movement was assessed using the Turkish version of the Tampa Scale for Kinesiophobia (TSK). This 17-item questionnaire utilizes a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree) to evaluate kinesiophobia and movement avoidance following an injury. After reverse-scoring items 4, 8, 12, and 16, a total score ranging from 17 to 68 is calculated, with higher scores indicating greater kinesiophobia.
Measured: At baseline and immediately post-intervention (4 weeks)
Functional disability
Functional disability was measured with the Oswestry Disability Index (ODI). The ODI consists of 10 sections related to daily living activities such as personal care, lifting, walking, sitting, standing, and sleeping. Each section is scored from 0 to 5. The total score ranges from 0 to 50, categorized as no disability (0-4), mild (5-14), moderate (15-24), severe (25-34), and complete disability (35-50).
Measured: At baseline and immediately post-intervention (4 weeks)
Perceived Deficits Questionnaire
Subjective cognitive function was evaluated using the Perceived Deficits Questionnaire (PDQ) developed by Sullivan et al. This 20-item scale assesses different domains of cognitive function, including attention/concentration, retrospective memory, prospective memory, and planning/organization. It is scored on a 5-point Likert-type scale (0 = never, 4 = almost always). Total scores range from 0 to 80, with higher scores reflecting greater perceived cognitive impairment over the past four weeks.
Measured: At baseline and immediately post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Mar 2024
- Primary completion1 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Chronic Back and Leg PainStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Tuğba DERE, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492784
- Sponsor's protocol ID
- Back School
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly available in order to protect participant confidentiality and in accordance with institutional and ethical data protection regulations.
Publications
Alvani E, Shirvani H, Shamsoddini A. Neuromuscular exercises on pain intensity, functional disability, proprioception, and balance of military personnel with chronic low back pain. J Can Chiropr Assoc. 2021 Aug;65(2):193-206.
PubMed 34658391Ibsen C, Schiottz-Christensen B, Vinther Nielsen C, Horder M, Schmidt AM, Maribo T. Assessment of functioning and disability in patients with low back pain - the low back pain assessment tool. Part 1: development. Disabil Rehabil. 2022 Aug;44(17):4841-4852. doi: 10.1080/09638288.2021.1913648. Epub 2021 May 4.
PubMed 33945363de Souza IMB, Merini LR, Rodrigues RSP, do Espirito Santo AS, Marques AP. Association of Functional Disability and Biopsychosocial Factors in Older Adults With Low Back Pain Who Live in the Amazonas State Brazil: A Cross-Sectional Study. J Manipulative Physiol Ther. 2022 Jan;45(1):45-56. doi: 10.1016/j.jmpt.2022.03.017. Epub 2022 Jun 24.
PubMed 35753876Shokri P, Zahmatyar M, Falah Tafti M, Fathy M, Rezaei Tolzali M, Ghaffari Jolfayi A, Nejadghaderi SA, Sullman MJM, Kolahi AA, Safiri S. Non-spinal low back pain: Global epidemiology, trends, and risk factors. Health Sci Rep. 2023 Sep 4;6(9):e1533. doi: 10.1002/hsr2.1533. eCollection 2023 Sep.
PubMed 37674621Harris JE, Boushey C, Bruemmer B, Archer SL. Publishing nutrition research: a review of nonparametric methods, part 3. J Am Diet Assoc. 2008 Sep;108(9):1488-96. doi: 10.1016/j.jada.2008.06.426.
PubMed 18755321Sullivan MJ, Hall E, Bartolacci R, Sullivan ME, Adams H. Perceived cognitive deficits, emotional distress and disability following whiplash injury. Pain Res Manag. 2002 Fall;7(3):120-6. doi: 10.1155/2002/502984.
PubMed 12420020Fisher K, Johnston M. Validation of the Oswestry low back pain disability questionnaire, its sensitivity as a measure of change following treatment and its relationship with other aspects of the chronic pain experience. Physiotherapy theory and practice. 1997;13(1):67-80.
Bayar K, Bayar B, Yakut E, Yakut Y. Reliability and construct validity of the Oswestry low back pain disability questionnaire in the elderly with low back pain. The Pain Clinic. 2003;15(1):55-9.
Lundberg MKE, Styf J, Carlsson SG. A psychometric evaluation of the Tampa Scale for Kinesiophobia - from a physiotherapeutic perspective. Physiotherapy Theory and Practice. 2004;20(2):121-33.
Yang QH, Wang XQ. Lumbar joint position sense measurement of patients with low back pain. EFORT Open Rev. 2023 Aug 1;8(8):639-650. doi: 10.1530/EOR-23-0077.
PubMed 37526253Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Poquet N, Lin CW, Heymans MW, van Tulder MW, Esmail R, Koes BW, Maher CG. Back schools for acute and subacute non-specific low-back pain. Cochrane Database Syst Rev. 2016 Apr 26;4(4):CD008325. doi: 10.1002/14651858.CD008325.pub2.
PubMed 27113258Ahern MM, Dean LV, Stoddard CC, Agrawal A, Kim K, Cook CE, Narciso Garcia A. The Effectiveness of Virtual Reality in Patients With Spinal Pain: A Systematic Review and Meta-Analysis. Pain Pract. 2020 Jul;20(6):656-675. doi: 10.1111/papr.12885. Epub 2020 May 21.
PubMed 32196892Li R, Li Y, Kong Y, Li H, Hu D, Fu C, Wei Q. Virtual Reality-Based Training in Chronic Low Back Pain: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2024 Feb 26;26:e45406. doi: 10.2196/45406.
PubMed 38407948Guo Q, Zhang L, Han LL, Gui C, Chen G, Ling C, Wang W, Gao Q. Effects of Virtual Reality Therapy Combined With Conventional Rehabilitation on Pain, Kinematic Function, and Disability in Patients With Chronic Neck Pain: Randomized Controlled Trial. JMIR Serious Games. 2024 Apr 24;12:e42829. doi: 10.2196/42829.
PubMed 38656775
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of a Virtual Reality-Based Back School Program on Pain, Functionality, and Kinesiophobia
- ClinicalTrials.gov ID
- NCT07492784
- Acronym / sponsor ID
- Back School
- Conditions
- Chronic Back and Leg Pain
- Keywords
- Back school, exercise, pain, physiotherapy, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 25 Mar 2026 (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 investigates the effects of a 4-week virtual reality (VR)-based back school program on pain, disability, fear of movement, and lumbar joint position sense (JPS) in individuals with chronic low back pain. Thirty-nine participants are allocated to either a VR-based back school group or a conventional back school group. Both groups perform supervised low back exercises. Pain, disability, proprioception, kinesiophobia, and perceived cognitive deficits are assessed before and after the intervention.
Detailed description
Background and Aim:
Chronic low back pain (CLBP) is a multidimensional condition associated with functional limitations, fear of movement, and proprioceptive impairments. Contemporary rehabilitation approaches, such as back school programs, are based on a biopsychosocial model and aim to enhance patient engagement. Virtual reality (VR) applications may further support these interventions by increasing motivation and providing enriched sensory feedback. This study aims to investigate the effects of a 4-week VR-based back school program on pain, disability, fear of movement, and joint position sense (JPS) in individuals with CLBP.
Methods:
The study includes 39 participants allocated into an experimental group (n=20) and a control group (n=19). The control group receives back school training through verbal instruction delivered by a physiotherapist, while the experimental group receives the same training integrated with a VR headset. Following the education sessions, both groups perform standard low back exercises under physiotherapist supervision.
Outcome measures include:
Pain intensity assessed using the Visual Analog Scale (VAS)
Disability assessed using the Oswestry Disability Index (ODI)
Lumbar joint position sense measured using a goniometric method
Fear of movement assessed using the Tampa Scale for Kinesiophobia (TSK)
Cognitive function assessed using the Perceived Deficits Questionnaire (PDQ)
All outcomes are evaluated before and after the 4-week intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pain intensity | Experimental | Other: Back school education integrated with a VR headsetIn this scale, the starting point is defined as "0 = no pain" and the end point as "10 = unbearable pain." Participants were asked to mark their current pain levels on this line. Pain levels were assessed separately at rest, during activity, and at night. |
| Lumbar joint position sense | Experimental | Other: Back school education integrated with a VR headsetParticipants were comfortably positioned, and the assessor passively moved their lumbar spine into a specific angle of flexion or extension. After holding the target angle for 3 seconds to allow proprioceptive encoding, participants were asked to actively replicate the position. The absolute error between the passively given angle and the actively replicated angle was recorded in degrees. |
| Tampa Scale for Kinesiophobia | Experimental | Other: Back school education integrated with a VR headsetThis 17-item questionnaire utilizes a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree) to evaluate kinesiophobia and movement avoidance following an injury. After reverse-scoring items 4, 8, 12, and 16, a total score ranging from 17 to 68 is calculated, with higher scores indicating greater kinesiophobia. |
| Functional disability | Experimental | Other: Back school education integrated with a VR headsetFunctional disability was measured with the Oswestry Disability Index (ODI) (17, 18). The ODI consists of 10 sections related to daily living activities such as personal care, lifting, walking, sitting, standing, and sleeping. Each section is scored from 0 to 5. The total score ranges from 0 to 50, categorized as no disability (0-4), mild (5-14), moderate (15-24), severe (25-34), and complete disability (35-50). |
| Perceived Deficits Questionnaire | Experimental | Other: Back school education integrated with a VR headsetSubjective cognitive function was evaluated using the Perceived Deficits Questionnaire (PDQ) developed by Sullivan et al. (19). This 20-item scale assesses different domains of cognitive function, including attention/concentration, retrospective memory, prospective memory, and planning/organization. It is scored on a 5-point Likert-type scale (0 = never, 4 = almost always). Total scores range from 0 to 80, with higher scores reflecting greater perceived cognitive impairment over the past four weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Presence of chronic low back pain for at least three months
- A resting pain intensity of 3 to 7 on the Visual Analog Scale (VAS)
- The cognitive ability to follow physiotherapy instructions
- Any physical therapy program within the previous 6 months
Key exclusion criteria (7 listed)
- Neurological deficits
- Vestibular pathologies
- Major trauma
- Active infections
- Tumors,
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 |
|---|---|---|
| Back school education integrated with a VR headsetAlso: Low back pain exercisesThe intervention lasted for 4 weeks, comprising 2 sessions per week (8 sessions in total). Following baseline assessments, participants were randomly allocated to either the experimental or control group based on their resting pain levels. The experimental group received back school education integrated with a VR headset, whereas the control group received the standard back school education via verbal instruction from a physiotherapist. Following the education sessions, both groups performed supervised conventional low back exercises. The intervention was progressively structured over the 4-week period. Exercises were individualized according to each patient's clinical status and tolerance, following the principle of progressive overload, while strictly avoiding pain provocation. | Other | Functional disability, Lumbar joint position sense, Pain intensity, Perceived Deficits Questionnaire, Tampa Scale for Kinesiophobia |
Primary outcome
Pain intensity
Time frame: At baseline and immediately post-intervention (4 weeks)
Pain intensity was evaluated using a 10-cm VAS developed by Price et al. In this scale, the starting point is defined as "0 = no pain" and the end point as "10 = unbearable pain." Participants were asked to mark their current pain levels on this line. Pain levels were assessed separately at rest, during activity, and at night.
Lumbar joint position sense
Time frame: At baseline and immediately post-intervention (4 weeks)
Lumbar joint position sense (JPS) was evaluated using a goniometric measurement method. Participants were comfortably positioned, and the assessor passively moved their lumbar spine into a specific angle of flexion or extension. After holding the target angle for 3 seconds to allow proprioceptive encoding, participants were asked to actively replicate the position. The absolute error between the passively given angle and the actively replicated angle was recorded in degrees.
Tampa Scale for Kinesiophobia
Time frame: At baseline and immediately post-intervention (4 weeks)
Fear of movement was assessed using the Turkish version of the Tampa Scale for Kinesiophobia (TSK). This 17-item questionnaire utilizes a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree) to evaluate kinesiophobia and movement avoidance following an injury. After reverse-scoring items 4, 8, 12, and 16, a total score ranging from 17 to 68 is calculated, with higher scores indicating greater kinesiophobia.
Functional disability
Time frame: At baseline and immediately post-intervention (4 weeks)
Functional disability was measured with the Oswestry Disability Index (ODI). The ODI consists of 10 sections related to daily living activities such as personal care, lifting, walking, sitting, standing, and sleeping. Each section is scored from 0 to 5. The total score ranges from 0 to 50, categorized as no disability (0-4), mild (5-14), moderate (15-24), severe (25-34), and complete disability (35-50).
Perceived Deficits Questionnaire
Time frame: At baseline and immediately post-intervention (4 weeks)
Subjective cognitive function was evaluated using the Perceived Deficits Questionnaire (PDQ) developed by Sullivan et al. This 20-item scale assesses different domains of cognitive function, including attention/concentration, retrospective memory, prospective memory, and planning/organization. It is scored on a 5-point Likert-type scale (0 = never, 4 = almost always). Total scores range from 0 to 80, with higher scores reflecting greater perceived cognitive impairment over the past four weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Results publication: PubMed 34658391Alvani E, Shirvani H, Shamsoddini A. Neuromuscular exercises on pain intensity, functional disability, proprioception, and balance of military personnel with chronic low back pain. J Can Chiropr Assoc. 2021 Aug;65(2):193-206.
- Results publication: PubMed 33945363Ibsen C, Schiottz-Christensen B, Vinther Nielsen C, Horder M, Schmidt AM, Maribo T. Assessment of functioning and disability in patients with low back pain - the low back pain assessment tool. Part 1: development. Disabil Rehabil. 2022 Aug;44(17):4841-4852. doi: 10.1080/09638288.2021.1913648. Epub 2021 May 4.
- Results publication: PubMed 35753876de Souza IMB, Merini LR, Rodrigues RSP, do Espirito Santo AS, Marques AP. Association of Functional Disability and Biopsychosocial Factors in Older Adults With Low Back Pain Who Live in the Amazonas State Brazil: A Cross-Sectional Study. J Manipulative Physiol Ther. 2022 Jan;45(1):45-56. doi: 10.1016/j.jmpt.2022.03.017. Epub 2022 Jun 24.
- Results publication: PubMed 37674621Shokri P, Zahmatyar M, Falah Tafti M, Fathy M, Rezaei Tolzali M, Ghaffari Jolfayi A, Nejadghaderi SA, Sullman MJM, Kolahi AA, Safiri S. Non-spinal low back pain: Global epidemiology, trends, and risk factors. Health Sci Rep. 2023 Sep 4;6(9):e1533. doi: 10.1002/hsr2.1533. eCollection 2023 Sep.
- Results publication: PubMed 18755321Harris JE, Boushey C, Bruemmer B, Archer SL. Publishing nutrition research: a review of nonparametric methods, part 3. J Am Diet Assoc. 2008 Sep;108(9):1488-96. doi: 10.1016/j.jada.2008.06.426.
- Results publication: PubMed 12420020Sullivan MJ, Hall E, Bartolacci R, Sullivan ME, Adams H. Perceived cognitive deficits, emotional distress and disability following whiplash injury. Pain Res Manag. 2002 Fall;7(3):120-6. doi: 10.1155/2002/502984.
- Results publicationFisher K, Johnston M. Validation of the Oswestry low back pain disability questionnaire, its sensitivity as a measure of change following treatment and its relationship with other aspects of the chronic pain experience. Physiotherapy theory and practice. 1997;13(1):67-80.
- Results publicationBayar K, Bayar B, Yakut E, Yakut Y. Reliability and construct validity of the Oswestry low back pain disability questionnaire in the elderly with low back pain. The Pain Clinic. 2003;15(1):55-9.
- Results publicationLundberg MKE, Styf J, Carlsson SG. A psychometric evaluation of the Tampa Scale for Kinesiophobia - from a physiotherapeutic perspective. Physiotherapy Theory and Practice. 2004;20(2):121-33.
- Results publication: PubMed 37526253Yang QH, Wang XQ. Lumbar joint position sense measurement of patients with low back pain. EFORT Open Rev. 2023 Aug 1;8(8):639-650. doi: 10.1530/EOR-23-0077.
- Results publication: PubMed 6226917Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
- Results publication: PubMed 27113258Poquet N, Lin CW, Heymans MW, van Tulder MW, Esmail R, Koes BW, Maher CG. Back schools for acute and subacute non-specific low-back pain. Cochrane Database Syst Rev. 2016 Apr 26;4(4):CD008325. doi: 10.1002/14651858.CD008325.pub2.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly available in order to protect participant confidentiality and in accordance with institutional and ethical data protection regulations.
Related trials for Chronic Back and Leg Pain
RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Recruiting
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Chronic Pain, Intractable Pain
RecruitingObservational study
RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Pain
Active, not recruitingPhase 4
Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain
Chronic, Intractable Back Pain and/or Leg Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back school education integrated with a VR headset in people with Chronic Back and Leg Pain, run by Hacettepe University at 1 site 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At baseline and immediately post-intervention (4 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07492784, which also lists 23 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 25 Mar 2026.