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Active, Not Recruiting

NCT Number: NCT06747819

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghurki trust and teaching hospital

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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