NCT07602816

Brief 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. (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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jan 2025Mar 2028

Study Start

First participant enrolled

January 22, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

May 15, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

back paincore stability exercisevirtual reality

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    4 weeks

Secondary Outcomes (1)

  • Tampa Scale of Kinesiophobia (TSK)

    4 weeks

Study Arms (3)

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.

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)

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).

Other: Group C

Interventions

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 A: traditional physiotherapy
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 B: receive traditional physiotherapy plus virtual reality.
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.

group C: receive traditional physiotherapy plus core stability exercise.

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassam Ahmed Nabil

Giza, Giza Governorate, 6892, Egypt

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 22, 2026

Study Start

January 22, 2025

Primary Completion (Estimated)

March 10, 2028

Study Completion (Estimated)

March 10, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations