Telerehabilitation in Managing Chronic Low Back Pain

The Effectiveness of Telerehabilitation Versus In-Person Rehabilitation in Managing Chronic Low Back Pain: a Pragmatic Randomized Non-Inferiority Trial

The purpose of this study is to determine whether telerehabilitation is as effective as in-person rehabilitation in treating patients with chronic back pain in actual clinical practice settings.T he study will recruit eighty-four individuals with chronic LBP, who will be randomly assigned to one of two groups: telerehabilitation (TR) or the control group, who will receive standard clinic therapy. The TR group will be treated remotely via phone calls and the Zoom platform. The intervention program will be customized according to the requirements and abilities of each patient. It will include self-management skills, education and support, including Pain Neuroscience Education , and customized exercises.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain (LBP)
• Intervention / Treatment: Other: Tele rehabilitation; Other: usual care only

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Adults aged 18 and above with non-specific chronic low back pain more than 12 weeks.

Exclusion Criteria: Cancer, systematic or neurological diseases, fracture, recent surgery on the spine and/or extremities, cognitive impairment, pregnant women, and communication barriers or other medical conditions contraindicating TR. If there is any presence of red flags, such as cauda equina syndrome, spinal infection, spinal compression fractures, spinal stress fractures, ankylosing spondylitis, or aneurysm will also be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Other: usual care only; in-person usual care provided by the physical therapist
Experimental: Tele rehabilitation	Other: Tele rehabilitation; The experimental group will receive the treatment remotely by ZOOM platform and phone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain measured by numeric rating scale	baseline and immediately after the intervention
function	measured by the Oswestry function index	baseline and immediately after the intervention

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB-PGS-2025-03-0019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No