Non Specific Low Back Paincore stabilityNCT07602816
Comparative Effect of Virtual Reality and Core Stability Exercises in Patients With Non-specific Chronic Low Back Pain
A study testing group A, Group B and Group C in people with Non Specific Low Back Pain, run by Emad Eldin Mohamed at 1 site in Egypt.
Trial summary
Non-specific low back pain (NSLBP) is a prevalent musculoskeletal disorder. (Maher et al., 2017). Globally, 60%-80% of adults' experience low back pain, with 10% developing chronic forms, of which 85% are classified as chronic nonspecific low back pain without a clear etiology. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Non Specific Low Back Pain
- What is being tested?
- group A, Group B and Group C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 25 May 2026to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sixty-six patients with non-specific low back pain diagnosed by physician will be selected for the study from the outpatient clinic of faculty of physical therapy, October 6 university.
- Patients of both sex with age range from 20-45 years.
- Pain lasting for more than 12 weeks.
- Pain intensity score 2/10 or more on Visual Analog Scale (VAS).
- BMI ranged between 18.5 and 24.9 kg/m2.
Who cannot join
- Visual or cognitive impairments affecting VR participation.
- Pregnancy.
- specific LBP (Radiculopathy, spinal stenosis, spondylolisthesis, or recent spinal surgery.)
- neurological disorders,
- psychiatric disorders,
- physiotherapy during the last 6 months.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Non-specific low back pain (NSLBP) is a prevalent musculoskeletal disorder. (Maher et al., 2017). Globally, 60%-80% of adults' experience low back pain, with 10% developing chronic forms, of which 85% are classified as chronic nonspecific low back pain without a clear etiology. (Alsufiany et al.,2020)..Despite various treatment modalities, a significant number of individuals continue to experience pain, functional limitations, and psychological distress such as kinesiophobia.
Read the detailed description
Non-specific low back pain (NSLBP) is a prevalent musculoskeletal disorder. (Maher et al., 2017). Globally, 60%-80% of adults' experience low back pain, with 10% developing chronic forms, of which 85% are classified as chronic nonspecific low back pain without a clear etiology. (Alsufiany et al.,2020)..Despite various treatment modalities, a significant number of individuals continue to experience pain, functional limitations, and psychological distress such as kinesiophobia.
Various strategies are employed to help improve range of motion, alleviate pain, and enhance the overall quality of life for individuals dealing with lower back pain (LBP). These strategies encompass therapeutic exercises, manual therapy techniques, educating patients on lifestyle modifications, managing medications, and utilizing modalities like cryotherapy, heat therapy, ultrasound, and electrical stimulation. (Rulewska et al., 2025). So, Physical therapies and exercises, psychological and social support, reducing strain during physical work, and lifestyle changes are commonly practiced to manage non-specific chronic low back pain (NSCLBP). (Kumari et al., 2024)
- Conditions
- Non Specific Low Back Pain
- Being tested
- group A, Group B, Group C
- Keywords
- back pain, core stability exercise, virtual reality
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group AOther
hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise.
Group BOther
Participants will engage in VR rehabilitation sessions using interactive balance and movement-based VR programs using meta quest with android operating system and camera as a sensor technology, it includes VR headset,2 touch controllers, 2 AA batteries, silicone cover, glasses spacer, charging cable , power adapter
Group COther
Traditional core exercises focused on deep trunk muscles, 3 sessions per week for 4 weeks, under therapist supervision.
It includes both isotonic and isometric core ex, During the ISOM exercises, patients were instructed to hold the contraction for 8 to 15 seconds, followed by a 5-second rest between each of the 4 sets, The ISOT exercises were performed in 4 sets, with 6 to 12 repetitions in each set. Additionally, a 1-minute rest was applied between each movement.
| Study group | Role | What they receive |
|---|---|---|
| group A: traditional physiotherapy | Experimental | hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise. Receives: Other: group A |
| group B: receive traditional physiotherapy plus virtual reality. | Experimental | Participants will engage in VR rehabilitation sessions, 3 sessions per week for 4 weeks using interactive balance and movement-based VR programs, the patient will performe the exercises using VR video gaming, two games were selected, one for each exercise set: Epic roller coaster and Fit x. In addition to being enjoyable for most of the participants, both games require frequent head motions and quick direction changes which facilitate activation of the core muscles. (Abdelraoufet al., 2020) Receives: Other: Group B |
| group C: receive traditional physiotherapy plus core stability exercise. | Experimental | Traditional core exercises focused on deep trunk muscles, 3 sessions per week for 4 weeks, under therapist supervision.
It includes both isotonic and isometric core ex, During the ISOM exercises, patients were instructed to hold the contraction for 8 to 15 seconds, followed by a 5-second rest between each of the 4 sets, The ISOT exercises were performed in 4 sets, with 6 to 12 repetitions in each set. Additionally, a 1-minute rest was applied between each movement. (Khaled et al., 2024). Receives: Other: Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
The questionnaire examines the level of disability in 10 everyday activities of daily living.
Each item consists of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability, disability scores ranging from 0-19% indicate minimal disability, 20-39% indicate moderate disability,40-59% indicate severe disability, 60-79% indicate crippling disability, and scores ranging from 80-100% indicate people who are confined to bed.
Measured: 4 weeks
visual analogue scale (VAS)
Pain intensity Level will be measured using the VAS that consists of a 10-cm straight line with endpoints defining pain intensity.
All patients will be asked to mark their pain level that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain imaginable". The distance between "0" and the mark made by the patients was measured using a ruler; a higher score indicates greater pain intensity.
Measured: 4 weeks
Star excursion balance test (SEBT)
Leg length discrepancy will be measured before applying the (SEBT) for normalization of test results, SEBT will be accomplished while participants are standing on the dominant leg, and participants will be asked to reach as far as they could along a grid in the anterior, posteromedial, and posterolateral directions with the tip of the great toe of the non-stance limb. Participant's hands held at the iliac crest during the test, If the individual touches heavily or comes to rest at the touch-down point, has to make contact with the ground with the reaching foot to maintain balance, or lifts or shifts any part of the foot of the stance limb during the trial, the trial is not considered complete.
Measured: 4 weeks
BROM
The AROM was determined by BROM and done by calculating the difference between the angle recorded in the starting position and the angle recorded at the end position. (Suriyaamarit et al., 2024) First step in measuring ROM is finding the reference points, which consisted of the base of the sacrum and the spinous process of thoracic spine level 12. The base of the sacrum was located by drawing a line between the posterior superior iliac spine (PSIS) (the same level as the S2 spinous process) and counting up from the base of the sacrum. The spinous process of thoracic spine level 12 was located by counting up six levels from the 1st reference point. These two references were used to place the flexion/extension unit and the BROM R/L unit.
Measured: 4 weeks
Secondary outcomes (1)
Tampa Scale of Kinesiophobia (TSK)
is a self-report questionnaire, in its original form, the TSK is a 17 item assessment checklist. It uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury. The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia. (Lundberg et al., 2011) Scores above 37 suggest the presence of clinically significant kinesiophobia, while scores below 37 are considered to be within the normal range.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start25 May 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emad Eldin Mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- October 6 University
- Responsible party
- Sponsor-investigator, Emad Eldin Mohamed, Middle East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602816
- Sponsor's protocol ID
- 987054
- Acronym
- core stability
- Status last verified
- Jun 2026
- First submitted
- 15 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Virtual Reality and Core Stability Exercises in Patients With Non-specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07602816
- Acronym / sponsor ID
- core stability / 987054
- Conditions
- Non Specific Low Back Pain
- Keywords
- back pain, core stability exercise, virtual reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Emad Eldin MohamedUniversity, hospital or other
- Collaborators
- October 6 University
- Study start
- 25 May 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 22 May 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.
Non-specific low back pain (NSLBP) is a prevalent musculoskeletal disorder. (Maher et al., 2017). Globally, 60%-80% of adults' experience low back pain, with 10% developing chronic forms, of which 85% are classified as chronic nonspecific low back pain without a clear etiology. (Alsufiany et al.,2020)..Despite various treatment modalities, a significant number of individuals continue to experience pain, functional limitations, and psychological distress such as kinesiophobia.
Detailed description
Non-specific low back pain (NSLBP) is a prevalent musculoskeletal disorder. (Maher et al., 2017). Globally, 60%-80% of adults' experience low back pain, with 10% developing chronic forms, of which 85% are classified as chronic nonspecific low back pain without a clear etiology. (Alsufiany et al.,2020)..Despite various treatment modalities, a significant number of individuals continue to experience pain, functional limitations, and psychological distress such as kinesiophobia.
Various strategies are employed to help improve range of motion, alleviate pain, and enhance the overall quality of life for individuals dealing with lower back pain (LBP). These strategies encompass therapeutic exercises, manual therapy techniques, educating patients on lifestyle modifications, managing medications, and utilizing modalities like cryotherapy, heat therapy, ultrasound, and electrical stimulation. (Rulewska et al., 2025). So, Physical therapies and exercises, psychological and social support, reducing strain during physical work, and lifestyle changes are commonly practiced to manage non-specific chronic low back pain (NSCLBP). (Kumari et al., 2024)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A: traditional physiotherapy | Experimental | Other: group Ahot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise. |
| group B: receive traditional physiotherapy plus virtual reality. | Experimental | Other: Group BParticipants will engage in VR rehabilitation sessions, 3 sessions per week for 4 weeks using interactive balance and movement-based VR programs, the patient will performe the exercises using VR video gaming, two games were selected, one for each exercise set: Epic roller coaster and Fit x. In addition to being enjoyable for most of the participants, both games require frequent head motions and quick direction changes which facilitate activation of the core muscles. (Abdelraoufet al., 2020) |
| group C: receive traditional physiotherapy plus core stability exercise. | Experimental | Other: Group CTraditional core exercises focused on deep trunk muscles, 3 sessions per week for 4 weeks, under therapist supervision. It includes both isotonic and isometric core ex, During the ISOM exercises, patients were instructed to hold the contraction for 8 to 15 seconds, followed by a 5-second rest between each of the 4 sets, The ISOT exercises were performed in 4 sets, with 6 to 12 repetitions in each set. Additionally, a 1-minute rest was applied between each movement. (Khaled et al., 2024). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sixty-six patients with non-specific low back pain diagnosed by physician will be selected for the study from the outpatient clinic of faculty of physical therapy, October 6 university.
- Patients of both sex with age range from 20-45 years.
- Pain lasting for more than 12 weeks.
- Pain intensity score 2/10 or more on Visual Analog Scale (VAS).
- BMI ranged between 18.5 and 24.9 kg/m2.
Key exclusion criteria (7 listed)
- Visual or cognitive impairments affecting VR participation.
- Pregnancy.
- specific LBP (Radiculopathy, spinal stenosis, spondylolisthesis, or recent spinal surgery.)
- neurological disorders,
- psychiatric disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group Ahot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise. | Other | group A: traditional physiotherapy |
| Group BParticipants will engage in VR rehabilitation sessions using interactive balance and movement-based VR programs using meta quest with android operating system and camera as a sensor technology, it includes VR headset,2 touch controllers, 2 AA batteries, silicone cover, glasses spacer, charging cable , power adapter | Other | group B: receive traditional physiotherapy plus virtual reality. |
| Group CTraditional core exercises focused on deep trunk muscles, 3 sessions per week for 4 weeks, under therapist supervision. It includes both isotonic and isometric core ex, During the ISOM exercises, patients were instructed to hold the contraction for 8 to 15 seconds, followed by a 5-second rest between each of the 4 sets, The ISOT exercises were performed in 4 sets, with 6 to 12 repetitions in each set. Additionally, a 1-minute rest was applied between each movement. | Other | group C: receive traditional physiotherapy plus core stability exercise. |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 4 weeks
The questionnaire examines the level of disability in 10 everyday activities of daily living. Each item consists of 6 statements which are scored from 0 to 5. With 0 indicating the least disability and 5 the greatest then the total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability, disability scores ranging from 0-19% indicate minimal disability, 20-39% indicate moderate disability,40-59% indicate severe disability, 60-79% indicate crippling disability, and scores ranging from 80-100% indicate people who are confined to bed.
visual analogue scale (VAS)
Time frame: 4 weeks
Pain intensity Level will be measured using the VAS that consists of a 10-cm straight line with endpoints defining pain intensity. All patients will be asked to mark their pain level that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain imaginable". The distance between "0" and the mark made by the patients was measured using a ruler; a higher score indicates greater pain intensity.
Star excursion balance test (SEBT)
Time frame: 4 weeks
Leg length discrepancy will be measured before applying the (SEBT) for normalization of test results, SEBT will be accomplished while participants are standing on the dominant leg, and participants will be asked to reach as far as they could along a grid in the anterior, posteromedial, and posterolateral directions with the tip of the great toe of the non-stance limb. Participant's hands held at the iliac crest during the test, If the individual touches heavily or comes to rest at the touch-down point, has to make contact with the ground with the reaching foot to maintain balance, or lifts or shifts any part of the foot of the stance limb during the trial, the trial is not considered complete.
BROM
Time frame: 4 weeks
The AROM was determined by BROM and done by calculating the difference between the angle recorded in the starting position and the angle recorded at the end position. (Suriyaamarit et al., 2024) First step in measuring ROM is finding the reference points, which consisted of the base of the sacrum and the spinous process of thoracic spine level 12. The base of the sacrum was located by drawing a line between the posterior superior iliac spine (PSIS) (the same level as the S2 spinous process) and counting up from the base of the sacrum. The spinous process of thoracic spine level 12 was located by counting up six levels from the 1st reference point. These two references were used to place the flexion/extension unit and the BROM R/L unit.
1 secondary outcome
Tampa Scale of Kinesiophobia (TSK)
Time frame: 4 weeks
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 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group A, Group B and Group C in people with Non Specific Low Back Pain, run by Emad Eldin Mohamed at 1 site in Egypt.
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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 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 Egypt. 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?
Oswestry Disability Index (ODI) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.