Lumbar Disc Prolapse With RadiculopathyNCT07041476
HYBRID TELE-REHABILITATION VERSUS CLINIC-BASED THERAPY IN PATIENTS WITH LUMBAR RADICULOPATHY: A RANDOMIZED CONTROLLED TRIAL
A study testing Exercise and telemedicine in people with Lumbar Disc Prolapse With Radiculopathy, run by Ahmed Adel Eid at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Lumbar Disc Prolapse With Radiculopathy
- What is being tested?
- Exercise and telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lumbar Disc Prolapse With Radiculopathy
- Being tested
- Exercise, telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
lumbar stabilisation exercises, Mackenzie exercises and neural mobilisation exercises
telemedicineOther
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
| Study group | Role | What they receive |
|---|---|---|
| HYBRID TELE-REHABILITATION | Experimental | Not described Receives: Other: Exercise; Other: telemedicine |
| clinic-based group | Active comparator | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 5 minuets
MUSCLE STRENGTH
trunk extensor and flexor muscle strength by the handheld dynamometry unit
Measured: 15 MIN
Sciatic nerve sensitivity
Assessment of Sciatic nerve sensitivity by the Straight Leg Raise test (SLR) with the goniometer
Measured: 5 MIN
Secondary outcomes (1)
fear avoidance beliefs questionnaire (FABQ)
The 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start30 May 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Prolapse With RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Adel Eid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Adel Eid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041476
- Sponsor's protocol ID
- P.T.REC/012/005870
- Status last verified
- Mar 2026
- First submitted
- 19 Jun 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYBRID TELE-REHABILITATION VERSUS CLINIC-BASED THERAPY IN PATIENTS WITH LUMBAR RADICULOPATHY: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07041476
- Acronym / sponsor ID
- P.T.REC/012/005870
- Conditions
- Lumbar Disc Prolapse With Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ahmed Adel EidUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYBRID TELE-REHABILITATION | Experimental | Other: Exercise, Other: telemedicine |
| clinic-based group | Active comparator | Other: Exercise |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- -
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exerciselumbar stabilisation exercises, Mackenzie exercises and neural mobilisation exercises | Other | HYBRID TELE-REHABILITATION, clinic-based group |
| telemedicineTele-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 | Other | HYBRID TELE-REHABILITATION |
Primary outcome
numeric pain rating scale (NPRS)
Time frame: 5 minutes
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
Oswestry disability index (ODI)
Time frame: 5 minuets
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.
MUSCLE STRENGTH
Time frame: 15 MIN
trunk extensor and flexor muscle strength by the handheld dynamometry unit
Sciatic nerve sensitivity
Time frame: 5 MIN
Assessment of Sciatic nerve sensitivity by the Straight Leg Raise test (SLR) with the goniometer
1 secondary outcome
fear avoidance beliefs questionnaire (FABQ)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and telemedicine in people with Lumbar Disc Prolapse With Radiculopathy, run by Ahmed Adel Eid at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric pain rating scale (NPRS) (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.