NCT05859321

Brief Summary

The goal of this clinical trial is to compare chronic low back patients. The main question\[s\] it aims to answer are:

  • pain and disability
  • fear avoidance belief Participants will perform virtual reality exercises
  • virtual reality based exercises
  • Routine Physical Therapy To Compare routine physical therapy treatment in addition to virtual reality to see effects on pain, functional disability and fear avoidance belief

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 18, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

April 18, 2023

Last Update Submit

August 6, 2023

Conditions

Keywords

low back painchronic low back painvirtual reality

Outcome Measures

Primary Outcomes (6)

  • Pain Intensity

    The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.

    at baseline

  • Functional disability

    Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.

    at baseline

  • Pain Intensity

    The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.

    at 4th week

  • Pain intensity

    The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in individuals,including those with chronic pain. Minimum socre is 0 out of 10 and Maximum 10, out of 10. Zero Indicates no pain and 10 indicates severe maximum pain.

    at 8th week

  • Functional Disability

    Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.

    4th week

  • Functional Disability

    Back pain functional scale (BPFS) is a standardized subjective assessment questionnaire that is used as Outcome tool to assess functional disability in acute and sub-acute low back pain.Minimum score is 0 out of 60 and 60 is maximum score. Zero score indicates unable to perform any functional activities and 60 indicates able to perfrom all functional activities.

    8th week

Secondary Outcomes (4)

  • Fear avoidance belief

    at baseline

  • Range of motion

    Change in range of motion score will be measured at baseline, at 8th week

  • Fear avoidance belief

    4th week

  • Fear avoidance belief

    8th week

Study Arms (2)

virtual reality

EXPERIMENTAL

virtual reality exercises will be administered along with routine physiotherapy

Other: Virtual reality Exercises

Routine Physiotherapy (treatment as usual)

ACTIVE COMPARATOR

transcutaneous electrical nerve stimulation,Heat Therapy, Stretching and strengthening exercises with Cycling will be administered

Other: Routine Physiotherapy

Interventions

Virtual reality exercises along with transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises

virtual reality

transcutaneous electrical nerve stimulation, Heat Therapy and Stretching and strengthening exercises

Also known as: treatment as usual
Routine Physiotherapy (treatment as usual)

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low back pain that persists for more than 12 weeks
  • Non-radiating low back pain
  • Mechanical low back pain
  • Both Gender

You may not qualify if:

  • trauma or fracture of the spine
  • any cardiac disease
  • any systematic disease
  • history of any neurological diseases such as Parkinson's disease, stroke and epilepsy
  • patient on corticosteroid or anticoagulants
  • history of any Drug abuse
  • any Congenital deformity
  • Virtual reality games phobia
  • Pregnant female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

ExergamingTherapeutics

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 15, 2023

Study Start

May 15, 2023

Primary Completion

July 30, 2023

Study Completion

August 5, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP, ICF

Locations