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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Pain
• Intervention / Treatment: Diagnostic test: Cervical Epidural Steroid Injection (CESI); Combination product: Neural Mobilization (NM)

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Ghurki Trust and Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group I	Diagnostic test: Cervical Epidural Steroid Injection (CESI); Participants in this group received CESI to reduce inflammation and alleviate pain in the cervical nerve roots.
Active Comparator: Interventional group II	Combination product: Neural Mobilization (NM); Participants in this group underwent NM exercises aimed at improving nerve mobility and reducing symptoms related to nerve compression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: MSRSW/Batch-Fall22/765

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No