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| ID | Type | Description | Link |
|---|---|---|---|
| Approval No: 2026-6375 | Registry Identifier | Necmettin Erbakan University Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-ILESI Only | Active Comparator | Participants receive fluoroscopy-guided cervical interlaminar epidural steroid injection and standardized general advice without a structured exercise program. |
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| C-ILESI + Home Exercise Program | Experimental | Participants receive fluoroscopy-guided cervical interlaminar epidural steroid injection followed by an eight-week standardized home-based exercise program in addition to general advice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Interlaminar Epidural Steroid Injection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The NDI was administered at baseline and at weeks 4, 8, and 12. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Pain intensity was recorded at baseline and at weeks 2, 4, 8, and 12. |
| Pittsburgh Sleep Quality Index (PSQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BANU GOKCEN BAYDOGAN TAN, MEDICAL DOCTOR | Contact | +90095058174097 | baydogan.g@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necmettin Erbakan University | Recruiting | Konya | Turkey | 045 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32183555 | Background | Daher A, Carel RS, Tzipi K, Esther H, Dar G. The effectiveness of an aerobic exercise training on patients with neck pain during a short- and long-term follow-up: a prospective double-blind randomized controlled trial. Clin Rehabil. 2020 May;34(5):617-629. doi: 10.1177/0269215520912000. Epub 2020 Mar 17. | |
| 29364754 | Background |
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Individual participant data collected in this study will not be publicly shared due to institutional data protection policies and ethical considerations regarding patient confidentiality.
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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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).
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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.
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| Home-Based Exercise Program | Behavioral | 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. |
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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. |
| PSQI was administered at baseline and at weeks 4,8 and 12. |
| 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. | EQ-5D-5L scores were obtained at baseline, week 4,8 and at week 12. |
| 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. | The EQ-VAS scores were obtained at baseline, week 4,8 and at week 12. |
| Chung S, Jeong YG. Effects of the craniocervical flexion and isometric neck exercise compared in patients with chronic neck pain: A randomized controlled trial. Physiother Theory Pract. 2018 Dec;34(12):916-925. doi: 10.1080/09593985.2018.1430876. Epub 2018 Jan 24. |
| 28750953 | Background | Noormohammadpour P, Tayyebi F, Mansournia MA, Sharafi E, Kordi R. A concise rehabilitation protocol for sub-acute and chronic non-specific neck pain. J Bodyw Mov Ther. 2017 Jul;21(3):472-480. doi: 10.1016/j.jbmt.2016.07.005. Epub 2016 Jul 25. |
| 21350618 | Background | Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available. |
| 31702624 | Background | Liang L, Feng M, Cui X, Zhou S, Yin X, Wang X, Yang M, Liu C, Xie R, Zhu L, Yu J, Wei X. The effect of exercise on cervical radiculopathy: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Nov;98(45):e17733. doi: 10.1097/MD.0000000000017733. |
| 35655692 | Background | Plener J, Ammendolia C, Hogg-Johnson S. Nonoperative management of degenerative cervical radiculopathy: protocol of a systematic review. J Can Chiropr Assoc. 2022 Apr;66(1):74-84. |
| 27250042 | Background | Iyer S, Kim HJ. Cervical radiculopathy. Curr Rev Musculoskelet Med. 2016 Sep;9(3):272-80. doi: 10.1007/s12178-016-9349-4. |
| 21824580 | Background | Bogduk N. The anatomy and pathophysiology of neck pain. Phys Med Rehabil Clin N Am. 2011 Aug;22(3):367-82, vii. doi: 10.1016/j.pmr.2011.03.008. |
| 32710604 | Background | Mansfield M, Smith T, Spahr N, Thacker M. Cervical spine radiculopathy epidemiology: A systematic review. Musculoskeletal Care. 2020 Dec;18(4):555-567. doi: 10.1002/msc.1498. Epub 2020 Jul 25. |
| 25985461 | Background | Woods BI, Hilibrand AS. Cervical radiculopathy: epidemiology, etiology, diagnosis, and treatment. J Spinal Disord Tech. 2015 Jun;28(5):E251-9. doi: 10.1097/BSD.0000000000000284. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |