Cervical Radiculopathy, Home Based Rehabilitation
Conditions
Keywords
Cervical Epidural Steroid Injection, Neck Pain, cervical radiculopathy, Home based exercise
Brief summary
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.
Detailed description
Chronic cervical radiculopathy is a common cause of neck and arm pain and may lead to significant disability, reduced quality of life, and sleep disturbances. Cervical epidural steroid injection is widely used to relieve radicular pain by reducing inflammation and nerve root irritation. Although injections may provide short-term pain relief, symptom recurrence and persistent functional limitations remain common. Exercise-based rehabilitation is an important component of conservative management for cervical spine disorders. Initiating rehabilitation during the period of pain relief following injection may help improve neuromuscular function and enhance long-term recovery. However, structured rehabilitation after spinal injections is not consistently incorporated into routine clinical practice, particularly in interventional pain settings. This prospective randomized controlled trial aims to evaluate the effectiveness of a standardized home-based exercise program initiated after cervical interlaminar epidural steroid injection in patients with chronic cervical radiculopathy. Participants will be randomly assigned to one of two groups: cervical epidural steroid injection alone or cervical epidural steroid injection followed by an eight-week home-based exercise program. The primary outcome will be neck-related disability assessed using the Neck Disability Index at 12 weeks. Secondary outcomes will include pain intensity, health-related quality of life, sleep quality, and analgesic medication use.
Interventions
Fluoroscopy-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.
BEHAVIORALHome-Based Exercise Program
Participants 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.
Sponsors
Necmettin Erbakan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, participant and care provider blinding was not feasible. Outcome assessments were performed by a blinded assessor who was unaware of group allocation. The statistician performing the analysis was also blinded to treatment assignment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to two parallel groups: cervical interlaminar epidural steroid injection alone (control group) or cervical interlaminar epidural steroid injection followed by an eight-week standardized home-based exercise program (intervention group).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Insufficient response to conservative treatment, including physical therapy, medication, and/or exercise therapy. * Ability to provide written informed consent and comply with study procedures.
Exclusion criteria
* Patients were excluded if any of the following were present: * 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. * Prior cervical spine surgery or cervical epidural steroid injection within the prespecified washout period. * Severe musculoskeletal or neurological comorbidities that could interfere with safe participation in the exercise program. * Discordance between clinical symptoms and imaging findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) | The NDI was administered at baseline and at weeks 4, 8, and 12. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | Pain intensity was recorded at baseline and at weeks 2, 4, 8, and 12. | Pain intensity was assessed using a NRS for neck and arm pain, where 0 indicated "no pain" and 10 indicated "worst imaginable pain." |
| Pittsburgh Sleep Quality Index (PSQI) | PSQI was administered at baseline and at weeks 4,8 and 12. | 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. |
| The EuroQol five-dimension, five-level questionnaire (EQ-5D-5L) | EQ-5D-5L scores were obtained at baseline, week 4,8 and at week 12. | 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. |
| EuroQol Visual Analogue Scale (EQ-VAS) | The EQ-VAS scores were obtained at baseline, week 4,8 and at week 12. | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBANU GOKCEN BAYDOGAN TAN, MEDICAL DOCTOR
Outcome results
None listed