Cervical PainNCT06747819
Effect of Cervical Epidural Steroid Injection With Neural Mobilization in Patients With Cervical Radicular Pain
A study testing Cervical Epidural Steroid Injection (CESI) and Neural Mobilization (NM) in people with Cervical Pain, run by Superior University at 1 site in Pakistan.
Trial summary
This study examines the effectiveness of cervical epidural steroid injections (CESI) and neural mobilization (NM), individually and in combination, in alleviating cervical radicular pain-a condition characterized by nerve root compression or irritation often due to herniated discs or bony spurs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Cervical Epidural Steroid Injection (CESI) and Neural Mobilization (NM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years, diagnosed with chronic cervical radicular pain.
- Patients with chronic cervical radicular pain (>6 months).
- Patients who had been confirmed through clinical examination and imaging studies (MRI or CT) showed evidence of nerve root compression.
- Participants were included if they provided written informed consent, demonstrated the ability to adhere to the study protocol, and committed to attending follow-up appointments while completing the required outcome measures.
Who cannot join
- Patient refusal.
- Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
- Patients with a history of cervical spine surgery, Uncontrolled Diabetes Mellitus, Hypertension Ischemic Heart Disease, and Pregnancy
- Patients with chronic pain syndromes that may interfere with cervical radicular pain evaluation, such as fibromyalgia, rheumatoid arthritis, or hypersensitivity, will be excluded. These disorders will be evaluated during screening using a complete medical history review, physical examination, and precise diagnostic criteria to guarantee correct detection of cervical radicular discomfort.
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the effectiveness of cervical epidural steroid injections (CESI) and neural mobilization (NM), individually and in combination, in alleviating cervical radicular pain-a condition characterized by nerve root compression or irritation often due to herniated discs or bony spurs. Cervical radiculopathy leads to chronic pain, sensory and motor deficits, and disability in the upper limbs.
Read the detailed description
The study is a randomized controlled trial conducted between April and October 2024, with patients diagnosed with cervical radicular pain randomized into three groups: CESI-only, NM-only, and combined CESI and NM.
- Conditions
- Cervical Pain
- Being tested
- Cervical Epidural Steroid Injection (CESI), Neural Mobilization (NM)
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Epidural Steroid Injection (CESI)Diagnostic test
Participants in this group received CESI to reduce inflammation and alleviate pain in the cervical nerve roots.
Neural Mobilization (NM)Combination product
Participants in this group underwent NM exercises aimed at improving nerve mobility and reducing symptoms related to nerve compression.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group I | Experimental | Not described Receives: Diagnostic Test: Cervical Epidural Steroid Injection (CESI) |
| Interventional group II | Active comparator | Not described Receives: Combination Product: Neural Mobilization (NM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Participants will rate their pain intensity on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. This measure will assess changes in pain levels from baseline through various follow-up points.
Measured: 12 Months
The Neck Disability Index (NDI)
The NDI consists of ten questions in the following domains: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation.
Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Aug 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747819
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/765
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Epidural Steroid Injection With Neural Mobilization in Patients With Cervical Radicular Pain
- ClinicalTrials.gov ID
- NCT06747819
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/765
- Conditions
- Cervical Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 24 Dec 2024 (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.
This study examines the effectiveness of cervical epidural steroid injections (CESI) and neural mobilization (NM), individually and in combination, in alleviating cervical radicular pain-a condition characterized by nerve root compression or irritation often due to herniated discs or bony spurs. Cervical radiculopathy leads to chronic pain, sensory and motor deficits, and disability in the upper limbs.
Detailed description
The study is a randomized controlled trial conducted between April and October 2024, with patients diagnosed with cervical radicular pain randomized into three groups: CESI-only, NM-only, and combined CESI and NM.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group I | Experimental | Diagnostic Test: Cervical Epidural Steroid Injection (CESI) |
| Interventional group II | Active comparator | Combination Product: Neural Mobilization (NM) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65 years, diagnosed with chronic cervical radicular pain.
- Patients with chronic cervical radicular pain (>6 months).
- Patients who had been confirmed through clinical examination and imaging studies (MRI or CT) showed evidence of nerve root compression.
- Participants were included if they provided written informed consent, demonstrated the ability to adhere to the study protocol, and committed to attending follow-up appointments while completing the required outcome measures.
Key exclusion criteria (4 listed)
- Patient refusal.
- Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
- Patients with a history of cervical spine surgery, Uncontrolled Diabetes Mellitus, Hypertension Ischemic Heart Disease, and Pregnancy
- Patients with chronic pain syndromes that may interfere with cervical radicular pain evaluation, such as fibromyalgia, rheumatoid arthritis, or hypersensitivity, will be excluded. These disorders will be evaluated during screening using a complete medical history review, physical examination, and precise diagnostic criteria to guarantee correct detection of cervical radicular discomfort.
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 |
|---|---|---|
| Cervical Epidural Steroid Injection (CESI)Participants in this group received CESI to reduce inflammation and alleviate pain in the cervical nerve roots. | Diagnostic test | Interventional group I |
| Neural Mobilization (NM)Participants in this group underwent NM exercises aimed at improving nerve mobility and reducing symptoms related to nerve compression. | Combination product | Interventional group II |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 12 Months
Participants will rate their pain intensity on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. This measure will assess changes in pain levels from baseline through various follow-up points.
The Neck Disability Index (NDI)
Time frame: 12 months
The NDI consists of ten questions in the following domains: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- 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 Cervical Epidural Steroid Injection (CESI) and Neural Mobilization (NM) in people with Cervical Pain, run by Superior University at 1 site in Pakistan.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2024. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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: 12 Months). The study lists 2 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 24 Dec 2024.