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| ID | Type | Description | Link |
|---|---|---|---|
| TTU-2022-14980 | Other Grant/Funding Number | Cukurova University |
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The purpose of this study is to demonstrate the efficacy of intramuscular betamethasone injection on pain and other clinical parameters in patients with radicular pain due to lumbar disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.
Low back pain is an important health problem that causes difficulties in daily living activities, loss of work performance and disability. Some patients with low back pain have radicular symptoms due to intervertebral disc herniation. Lumbar radiculopathy is characterized by radiating buttock and leg pain in a lumbar nerve root distribution.
The pathophysiology of radiculopathy is related to compression of the nerve, as well as the local release of inflammatory cytokines. Systemic corticosteroids have been used for treatment of lumbar radicular pain for a long time. The effects of corticosteroids are related to their anti-inflammatory effects, which may help reduce swelling and related compression on the affected nerve. Corticosteroids can be used systemically (i.e. oral, intravenous, or intramuscular routes) or administered directly into spinal structures through injections.
In the current study, the investigators aimed to demonstrate the efficacy of intramuscular betamethasone injection on pain, disability and health related quality of life in patients with lumbar radicular pain due to disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucocorticoid injection | Active Comparator | Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate) |
|
| Placebo injection | Placebo Comparator | Intramuscular saline (%0.9 isotonic sodium chloride) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucocorticoids | Drug | Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar radicular pain | Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome) | Week 1 |
| Lumbar radicular pain | Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome) | Month 1 |
| Lumbar radicular pain | Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome) | Month 3 |
| Disability | Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome) | Month 1 |
| Disability | Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome) | Month 3 |
| Health related quality of Life | Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome) | Month 1 |
| Health related quality of Life | Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome) | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Electrophysiological evaluation (Sensory NCS) | Sensory nerve conduction study (m/s) | Month 1 |
| Electrophysiological evaluation (Motor NCS) | Motor nerve conduction study (m/s) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sibel Basaran, MD, Prof | Cukurova University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University | Adana | 01330 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40616084 | Derived | Boga Vijdan E, Basaran S, Balal M. Efficacy of intramuscular glucocorticoid injection in patients with lumbar radicular pain: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Jul 4;26(1):650. doi: 10.1186/s12891-025-08897-1. |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005938 | Glucocorticoids |
| C032812 | betamethasone dipropionate, betamethasone sodium phosphate drug combination |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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| Placebo | Other | Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day) |
|
| Month 1 |
| Electrophysiological evaluation (F wave) | F wave (m/s) | Month 1 |
| Electrophysiological evaluation (H reflex) | H reflex (m/s) | Month 1 |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |