HYBRID TELE-REHABILITATION VERSUS CLINIC-BASED THERAPY IN PATIENTS WITH LUMBAR RADICULOPATHY: A RANDOMIZED CONTROLLED TRIAL

NCT07041476 | Completed DMC

• 1 other identifier: P.T.REC/012/005870
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A single blinded clinical randomized trial. A single blinded trained investigator examined all patients and collect all data to eliminate inter- investigator error. Patients will be divided according to the treatment procedure into two groups equal in numbers to investigate a comparative effect of hybrid tele-rehabilitation to clinic- based therapy in patients with lumbar radiculopathy.

Conditions

Lumbar Disc Prolapse With Radiculopathy

Outcome Measures

Primary Outcomes (4)

• numeric pain rating scale (NPRS)

  The NPRS is frequently employed to measure pain intensity, in which patients are asked to select a number (from 0 to 10) to represent their pain severity before and after medical consultation

  5 minutes

• Oswestry disability index (ODI)

  used to measure the functional status of patients with spinal disorders. It is comprised of 10 dimensions with 6 levels being set in each dimension.

  5 minuets

• MUSCLE STRENGTH

  trunk extensor and flexor muscle strength by the handheld dynamometry unit

  15 MIN

• Sciatic nerve sensitivity

  Assessment of Sciatic nerve sensitivity by the Straight Leg Raise test (SLR) with the goniometer

  5 MIN

Secondary Outcomes (1)

• fear avoidance beliefs questionnaire (FABQ)

  5 minutes

Study Arms (2)

HYBRID TELE-REHABILITATION

EXPERIMENTAL

Other: Exercise; Other: telemedicine

clinic-based group

ACTIVE COMPARATOR

Other: Exercise

Interventions

telemedicine OTHER

Tele-rehabilitation will be achieved through a video conference (VC) via the internet platform Zoom at the time and day decided upon with the therapist and the patient

HYBRID TELE-REHABILITATION

Exercise OTHER

lumbar stabilisation exercises, Mackenzie exercises and neural mobilisation exercises

HYBRID TELE-REHABILITATION; clinic-based group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Both genders will be involved, 2) Symptoms started within more than 4 weeks (Ghasabmahaleh et al., 2021). 3) Patients' age ranges from 25-45 years (Karthick et al., 2024). 4) All patients will be referred by the physician after confirmed diagnosis of lumbar radiculopathy at L4/5 or L5/S1 level through clinical assessment and imaging studies.
• \) Patients have sufficient education level. 6) Body mass index for patients will be from 18.5 to 29.9.

You may not qualify if:

• \) History of pelvic, hips, or spine surgery, 2) Any unstable lumbar condition such as spinal fractures, tumor, cauda equina syndrome and spondylolisthesis (Ghasabmahaleh et al., 2021).
• History of neurological disorders causing radicular pain, 4) Any preexisting injury that may become exacerbated or made worse with participation (Zainab et al., 2022).
• \) Cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders (Vijayaraj., 2018).

Sponsors & Collaborators

• Ahmed Adel Eid: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Exercise; Telemedicine

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Delivery of Health Care; Patient Care Management; Health Services Administration

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: SPONSOR INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: May 30, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)