Home-Based Exercise After Cervical Epidural Steroid Injection for Cervical Radiculopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNecmettin Erbakan University
About this trial
Cervical radiculopathy is a common cause of neck and arm pain resulting from compression or inflammation of a cervical nerve root. Cervical epidural steroid injection is frequently used to reduce pain and improve function in patients who do not respond to conservative treatment. However, long-term functional recovery may require additional rehabilitation strategies. This randomized controlled trial aims to investigate whether adding a standardized home-based exercise program after cervical interlaminar epidural steroid injection improves pain, disability, sleep quality, and quality of life in patients with chronic cervical radiculopathy. Participants will be randomly assigned to receive either injection alone or injection followed by an eight-week home-based exercise program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 70 years.
Chronic cervical radicular pain lasting ≥3 months, characterized by neck pain with accompanying arm pain consistent with a cervical nerve root distribution.
Average pain intensity ≥4/10 on the Numeric Rating Scale (NRS) over the preceding 7 days at baseline.
Diagnosis of chronic cervical radiculopathy due to cervical disc herniation, confirmed by clinical examination and cervical MRI findings at the corresponding level.
Disqualifiers
Clinical signs of cervical myelopathy or progressive neurological deficit.
Suspicion of serious spinal pathology (e.g., infection, malignancy).
Contraindications to epidural steroid injection, including uncontrolled coagulopathy, anticoagulant therapy not appropriately managed, or local/systemic infection.
Pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Cervical Interlaminar Epidural Steroid Injection
Procedure/SurgeryFluoroscopy-guided cervical interlaminar epidural steroid injection performed at the C7-T1 interlaminar space using a paramedian approach. Epidural placement is confirmed with contrast medium under fluoroscopic visualization. A total of 8 mg dexamethasone is injected into the epidural space to reduce inflammation and nerve root irritation associated with cervical radiculopathy.
Home-Based Exercise Program
BehavioralParticipants perform a standardized home-based neck exercise program initiated after cervical epidural steroid injection and continued for 8 weeks. The program includes cervical mobility exercises, isometric strengthening exercises, deep cervical muscle activation, and stretching exercises targeting the upper trapezius and levator scapulae muscles. Exercises are performed five days per week for approximately 15-20 minutes per session. Participants receive initial supervised instruction and a printed exercise brochure to facilitate correct performance and adherence.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: C-ILESI OnlyActive comparator 1 intervention
Group B: C-ILESI + Home Exercise ProgramExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Neck Disability Index (NDI)
The primary outcome was the between-group difference in change in neck-related disability, assessed using the NDI, from baseline to week 12. The NDI is a validated, self-administered questionnaire consisting of 10 items evaluating pain intensity and functional limitations related to neck pain. Each item is scored on a 0-5 scale, yielding a total score ranging from 0 to 50, which was converted to a percentage score (0-100), with higher scores indicating greater disability. The NDI was administered at baseline and at weeks 4, 8, and 12.
Time frame
The NDI was administered at baseline and at weeks 4, 8, and 12.Secondary outcomes
1
Numeric Rating Scale (NRS)
Pain intensity was assessed using a NRS for neck and arm pain, where 0 indicated "no pain" and 10 indicated "worst imaginable pain."
Time frame
Pain intensity was recorded at baseline and at weeks 2, 4, 8, and 12.2
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality was assessed using the PSQI, a validated self-administered questionnaire evaluating subjective sleep quality over the past month. The PSQI yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame
PSQI was administered at baseline and at weeks 4,8 and 12.3
The EuroQol five-dimension, five-level questionnaire (EQ-5D-5L)
Health-related quality of life will be assessed using the EQ-5D-5L descriptive system. The index score is derived from five dimensions and ranges from values below 0 (worse than death) to 1 (perfect health). Higher scores indicate better health status.
Time frame
EQ-5D-5L scores were obtained at baseline, week 4,8 and at week 12.4
EuroQol Visual Analogue Scale (EQ-VAS)
The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better perceived health.
Time frame
The EQ-VAS scores were obtained at baseline, week 4,8 and at week 12.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov