- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07602816
Comparative Effect of Virtual Reality and Core Stability Exercises in Patients With Non-specific Chronic Low Back Pain (core stability)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypt, 6892
- Rania Reda
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A: traditional physiotherapy
hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise.
|
hot back, TENS, stretching exercise for Hamstring, Hip flexors, Back extensors and strengthening ex for back extensors and abdominal muscles each exercise.
|
|
Experimental: group B: receive traditional physiotherapy plus virtual reality.
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)
|
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
|
|
Experimental: group C: receive traditional physiotherapy plus core stability exercise.
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). |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
4 weeks
|
|
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. |
4 weeks
|
|
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.
|
4 weeks
|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale of Kinesiophobia (TSK)
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 987054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Specific Low Back Pain
-
Lincoln University CollegeCairo University; Taif UniversityNot yet recruitingNon Specific Low Back Pain
-
Riphah International UniversityCompletedNon Specific Low Back PainPakistan
-
Laval UniversityMedTeq; Corset Saint-FrancisRecruitingNon-specific Low Back PainCanada
-
Bahçeşehir UniversityNot yet recruitingNon-specific Low Back PainTurkey (Türkiye)
-
Bahçeşehir UniversityNot yet recruitingChronic Non-specific Low Back PainTurkey (Türkiye)
-
Kirsehir Ahi Evran UniversitesiRecruitingEffects of Virtual Reality-Assisted Pain Neuroscience Education on Chronic Nonspecific Low Back PainChronic Non-Specific Low Back PainTurkey (Türkiye)
-
University of HailNot yet recruitingNon Specific Chronic Low Back PainSaudi Arabia
-
Maheen RaufRecruitingNon-specific Chronic Low Back PainPakistan
-
University Hospital, MontpellierNot yet recruitingNon-specific Low Back Pain (NSLBP)
-
Ehab Mohamed Kamel AhmedThe Scientific Research Deanship, University of Ha'ilNot yet recruitingNon-specific Low Back Pain (NSLBP)Saudi Arabia
Clinical Trials on group A
-
Hongxia WangRecruiting
-
Fayoum UniversityNot yet recruitingZygomatic ImplantsEgypt
-
BioSyngen Pte LtdSouth China Hospital of Shenzhen UniversityNot yet recruiting
-
Chung Shan Medical UniversityCompleted
-
The University of Texas Health Science Center,...National Institute for Occupational Safety and Health (NIOSH/CDC)Completed
-
Kahramanmaras Sutcu Imam UniversityCompletedPain | Interleukin | Vessels; VaricoseTurkey
-
Manuel RodríguezUnknownBrain IschemiaSpain
-
Kafrelsheikh UniversityActive, not recruitingPulmonary Dysfunction | Spastic DiaplegiaEgypt
-
BioSyngen Pte LtdSouth China Hospital of Shenzhen UniversityNot yet recruitingColorectal Cancer | Pancreatic Cancer
-
Dr. Jean-Sebastien Delisle, MD, PhDCompletedLymphoma | Epstein-Barr Virus Infections | Post-Transplant Lymphoproliferative DisorderCanada