Effect of Cervical Epidural Steroid Injection With Neural Mobilization in Patients With Cervical Radicular Pain

NCT06747819 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/765
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. Cervical radiculopathy leads to chronic pain, sensory and motor deficits, and disability in the upper limbs.

Conditions

Cervical Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  12 months

Study Arms (2)

Interventional group I

EXPERIMENTAL

Diagnostic Test: Cervical Epidural Steroid Injection (CESI)

Interventional group II

ACTIVE COMPARATOR

Combination Product: Neural Mobilization (NM)

Interventions

Cervical Epidural Steroid Injection (CESI) DIAGNOSTIC_TEST

Participants in this group received CESI to reduce inflammation and alleviate pain in the cervical nerve roots.

Interventional group I

Neural Mobilization (NM) COMBINATION_PRODUCT

Participants in this group underwent NM exercises aimed at improving nerve mobility and reducing symptoms related to nerve compression.

Interventional group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Ghurki trust and teaching hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 24, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: February 28, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)