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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07041476
Enrollment
32
Registered
2025-06-27
Start date
2025-05-30
Completion date
2025-09-30
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Prolapse With Radiculopathy

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.

Detailed description

All patients will sign an informed consent form after receiving information on the purpose of the study, procedure, and possible benefits and risks, privacy and use of data. All patients will be evaluated before training and at the end of the six-week training period with the handheld dynamometry unit for the trunk flexor and extensor muscle strength, Numeric Pain Rating Scale (NPRS) for pain, Oswestry disability index (ODI) for function, Fear avoidance beliefs questionnaire (FABQ) for psychological status and Straight leg raise test (SLR) for sciatic nerve sensitivity.

Interventions

OTHERExercise

lumbar stabilisation exercises, Mackenzie exercises and neural mobilisation exercises

OTHERtelemedicine

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

Sponsors

Ahmed Adel Eid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

\- 1\) 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. 5\) Patients have sufficient education level. 6) Body mass index for patients will be from 18.5 to 29.9.

Exclusion criteria

* 1\) 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). 5\) 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).

Design outcomes

Primary

MeasureTime frameDescription
numeric pain rating scale (NPRS)5 minutesThe 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
Oswestry disability index (ODI)5 minuetsused to measure the functional status of patients with spinal disorders. It is comprised of 10 dimensions with 6 levels being set in each dimension.
MUSCLE STRENGTH15 MINtrunk extensor and flexor muscle strength by the handheld dynamometry unit
Sciatic nerve sensitivity5 MINAssessment of Sciatic nerve sensitivity by the Straight Leg Raise test (SLR) with the goniometer

Secondary

MeasureTime frameDescription
fear avoidance beliefs questionnaire (FABQ)5 minutesThe questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale, where 0= completely disagree, 6=completely agree.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026