Virtual Reality Vased Exercises and Hyperlordosis in Low Back Pain

NCT06868329 | Completed

• 1 other identifier: H-2025-675
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

this study aimed to evaluate the impact of incorporating postural correction exercises through VR video gaming on lumbar lordotic angle (LLA), pain, range of motion (ROM), and function in patients with chronic non-specific low back pain (CNLBP). Furthermore, the study sought to assess satisfaction and commitment levels when VR was integrated into the exercise regimen

Conditions

Hyperlordosis

Keywords

lordosis; low back pain; lumbar curve; virtual reality; TBed

Outcome Measures

Primary Outcomes (4)

• Intensity of low back Pain

  Pain intensity will be assessed using NPRS. This scale consists of a horizontal 10cm line numbered from 0 to 10. The higher numbers indicate higher pain intensity while lower numbers indicate lower pain intensity. The validity and reliability of this scale for measuring musculoskeletal pain were approved in previous work. Participants were asked to select the number that represents their current pain level.

  at base line and after 8 weeks of tretment

• Active ROM of the lumbar spine

  Active Lumbar flexion and extension were assessed using the Back range of motion (BROM) device. This device was designed to assess the ROM of the lumbosacral region. It consisted of a set of inclinometers - attached to two plastic frames - arranged in vertical and horizontal fashions to assess the sagittal, frontal, and rotational movement of the lower back. BROM is a valid and reliable device for measuring lumbar ROM. The current study used BROM (Performance Attainment Associates, Roseville, Minnesota) to assess active flexion and extension of the lumbar spine. Measurements were taken according to the guidelines described previously. The AROM was determined by calculating the difference between the angle recorded in the starting position and the angle recorded at the end position of either flexion or extension.

  at base line and after 8 weeks of tretment

• Lumbar lordotic angle (LLA)

  LLA will be measured using a Flexi curve ruler. A flexi ruler is utilized as a non-invasive tool to assess lumbar curvature. This 60 cm ruler is constructed from special steel and coated with plastic, allowing it to be bent to match the lumbar curve and maintain its shape. Its reliability and validity have been previously confirmed. The assessment will be conducted by an assessor who will be unaware of the patient's intervention allocations. To measure the lumbar curve, patients will stand with their knees extended and feet about shoulder-width apart, while the lordosis was measured between the L1 and S2 prominences. The angle between L1 and S2, referred to as the Ө angle, will be calculated using the formula: Ө = 4\[Arc tan (2H/L)\], where L is the line connecting the two ends of the curve, and H is the maximum distance between L and the curve. The normal lordosis angle is 30 degrees, while angles exceeding 40 degrees are classified as hyper

  at base line and after 8 weeks of tretment

• Functional level

  The Oswestry Disability Index (ODI) was used to assess functional disability levels. It consists of 10 sections covering the discomfort of the back and the activities conducted every day. Each item has six answers with a score range from 0-5 according to the arrangement of the statement as 1st refers to 0 and the 2nd takes 1, etc. Then the scores were added to reach the total score ranging from 0 - 50. This score can be used as raw data or it can be used to calculate a percentage. In either case, lower values indicate better function and higher values indicate more disability. In the current study, the raw data was used to conduct the analysis, as it was considered more sensitive to show minor changes compared to ratio values. The validity and reliability of the ODI have been studied and shown to have a high level , where the ICC for the reliability range (0.96-0.88).

  at base line and after 8 weeks of tretment

Secondary Outcomes (2)

• Satisfaction level

  after 8 weeks of tretment

• Commitment to exercise sessions

  after 8 weeks of tretment

Study Arms (2)

VR TBed group

EXPERIMENTAL

this arm will receive superficial moist heat, hamstring and low back stretching plus posterior pelvic tilting exercises applied using TBed virtual reality gaming system,

Other: Superficial moist heat; Other: Hamstring and back muscles stretching; Other: Postural correction with lumbar stabilization using TBed

Control group

ACTIVE COMPARATOR

this arm will receive superficial moist heat, hamstring and low back stretching plus posterior pelvic tilting exercises applied using the traditional technique from supine position

Other: Superficial moist heat; Other: Hamstring and back muscles stretching; Other: posterior pelvic tilting exercises regular procedures

Interventions

Superficial moist heat OTHER

Twenty minutes of automatic moist hot pack (Besmed© BE-267, Taiwan) of suitable size was used to apply superficial heat. The heat level was adjusted to the medium level. While the moist environment was assured by placing a moist sponge layer between the pack and its cotton outer coverage. The duration was calculated after 8 minutes of warming up (when the temperature reaches its maximum level). The patient-reported sensation should be moderate warmth. A thermal sensation test using two test tubes was performed before applying heat therapy to avoid any adverse effects

Control group; VR TBed group

Hamstring and back muscles stretching OTHER

Patients received manual passive stretch for the hamstring and lower back muscles. Three repetitions per session with every repetition sustained for 30 s. The patient assumed a long sitting position with both knees in full extension and feet together. The patient was then asked to bend forward from the hips to reach the furthest point towards the feet. The therapist applied over pressure by pressing hands on the patient's upper back and pushing forward.

Control group; VR TBed group

posterior pelvic tilting exercises regular procedures OTHER

Patients will be asked to assume the supine position with both knees semi-flexed. A small billow will be placed under the low back, another billow will be placed under the flexed knees for comfort. The patient will be asked to tuck the abdominal muscles inward and press with the low back on the underlying billow and hold for six seconds, then relax. after a few seconds of rest, the patient should repeat this procedure for 3 sets X 10 repetitions per session during the first 2 weeks. the number of sets will be increased according to the adaptation of each patient and his/her fatigue threshold.

Control group

Postural correction with lumbar stabilization using TBed OTHER

These exercises consisted of pelvic rocking, and activation of the upper back and interscapular muscles. TBed from Techno body©, Italy was used to assist the patient to perform these exercises through VR video gaming interface. The patients in the experimental group will be asked to contract the targeted muscles and push down on the surface of the TBed. Patient's pressure will activate the sensors inserted inside the TBed, which will be reflected on the game as triggering of the gun that targets flying fruits. The game consists of three levels, easy, medium, and hard. The patient will be asked to play the game for the lower back where pushing the lower back against the bed (posterior pelvic tilting) triggered the gun and for the upper back where pushing the scapula against the bed was the triggering action.

VR TBed group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• males or females,
• years of age,
• unilateral, bilateral, or central (midline) pain in the low back,
• demonstrate lumbar hyper lordosis of the lumbar spine (lumbar lordotic angle more than 40°, measured using flexi ruler and spinal mouse) (Tack 2021),
• pain persists for 3 months or more,
• pain intensity between 2 -6 on numeric pain rating scale (NPRS).

You may not qualify if:

• acute low back pain (less than 3 months),
• specific pain due to well diagnosed pathology such as trauma, surgery, dick lesion, tumor, adhesions.
• Low back pain associated with sciatica, patients who cannot stop using analgesic drugs during the period of the study.

Sponsors & Collaborators

• University of Hail: lead

Study Sites (1)

University of Hail

Hail, Ha'il Region, 3994, Saudi Arabia

Location

MeSH Terms

Conditions

Swayback; Lordosis; Low Back Pain

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Sheep Diseases; Animal Diseases; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All research-involved personnel will be concealed to the initial allocation of the patients to groups. The allocation process will be conducted by an administrative employer not involved in the assessment nor treatment. Permuted blocks method of randomization (block size 4 and 6) was used to ensure 1:1 allocation ratio. The numbers. Blinding will be assured by giving each participant a code number that will be used throughout the study. The therapist will only be allowed to reveal the interpretation of the code to allow him to provide the appropriate intervention. Patients, the assessor, and the statistician will be kept blind throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 10, 2025
• Study Start: March 6, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)