Cervical Epidural Block in Chronic Neck Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAlİ Eman, MD

About this trial

Chronic neck pain can negatively affect daily activities, work ability, and quality of life. Cervical epidural block is commonly used to reduce pain and inflammation, while exercise and physical therapy aim to improve muscle strength, endurance, movement control, and physical function. However, there is limited evidence comparing cervical epidural block alone with its combined use with exercise or physical therapy.

This study aims to compare the effects of three treatment approaches in patients with chronic neck pain associated with cervical disc pathology or degenerative changes. Participants will receive cervical epidural block alone, cervical epidural block combined with cervical stabilization exercises, or cervical epidural block combined with physical therapy. Pain intensity, neck-related disability, and quality of life will be evaluated before treatment and at 1, 3, and 6 months after treatment using the Numeric Rating Scale, Neck Disability Index, and 12-Item Short Form Health Survey. The study will determine whether adding exercise or physical therapy to cervical epidural block provides additional clinical and functional benefits.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 55 years

Neck pain lasting longer than 3 months

Diagnosis of cervical radiculopathy

Numeric Rating Scale (NRS) pain score of 5 or higher

Disqualifiers

History of spinal surgery

Cervical spondylolisthesis

Spinal stenosis

Presence of a neurological deficit

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cervical Epidural Steroid Injection

    Procedure/Surgery

    Participants receive a cervical epidural steroid injection for the treatment of chronic neck pain associated with cervical radiculopathy.

  • Cervical Stabilization Exercise Program

    Behavioral

    Participants perform a cervical stabilization exercise program in addition to cervical epidural steroid injection.

  • Physical Therapy Program

    Other intervention

    Participants receive a physical therapy program in addition to cervical epidural steroid injection.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Cervical Epidural Steroid InjectionExperimental treatment 1 intervention
Group B: Cervical Epidural Steroid Injection With Cervical Stabilization ExercisesExperimental treatment 2 interventions
Group C: Cervical Epidural Steroid Injection With Physical TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Pain Intensity Assessed by the Numeric Rating Scale

Pain intensity will be assessed using the Numeric Rating Scale (NRS). Participants rate their pain on an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate lower pain intensity. Changes from baseline will be compared among the three treatment groups.

Time frame
Baseline and 1, 3, and 6 months after treatment

Secondary outcomes

1

Change in Neck-Related Disability Assessed by the Neck Disability Index

Neck-related disability will be assessed using the Neck Disability Index (NDI). The questionnaire consists of 10 items, each scored from 0 to 5, with a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability. Changes from baseline will be compared among the three treatment groups.

Time frame
Baseline and 1, 3, and 6 months after treatment
2

Change in Health-Related Quality of Life Assessed by the 12-Item Short Form Health Survey

Health-related quality of life will be assessed using the 12-Item Short Form Health Survey (SF-12). The questionnaire provides Physical Component Summary and Mental Component Summary scores. Higher scores indicate better health-related quality of life. Changes from baseline will be compared among the three treatment groups.

Time frame
Baseline and 1, 3, and 6 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alİ Eman, MD

Lead sponsor

Sakarya University

Sponsor institution