APICALE - Cervical facet injection of corticosteroids for the management of cervicobrachialgia : protocol for a randomized pilot study

Conditions

Cervicobrachial Neuralgia

Brief summary

Radicular pain (RP) assessed using a simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the 1-month visit assessment compared to the baseline.

Detailed description

Cervical pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, 1 month, 2 month and 3 month,, The Neck Disability Index (NDI) score (self-administered functional scale, ranging from 0 to 50) at Month 1 and Month 3, and professional status (self-reported: employed, on sick leave, disabled, unemployed, inactive, retired) at Month 1 and Month 3,, The self-administered EQ-5D-5L quality of life scale at Month 1 and Month 3,, Radicular pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, month 2, and month 3,, The occurrence of adverse events (AEs) and serious adverse events (SAEs) at each visit. Surgical intervention will be considered as a SAE, The use of analgesics (levels 1, 2, or 3) since the last visit, using a self-administered 4-level scale (never, several times a month, several times a week, daily) at Day 15, 1, 2 and 3 months post-injection.

Related papers

No related papers found yet.

Interventions

DRUGNaCl 0.9%

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Radicular pain (RP) assessed using a simple self-administered numeric rating scale, ranging from 0 (no pain) to 100 (maximum pain), over the 48 hours preceding the 1-month visit assessment compared to the baseline.	—

Secondary

Measure	Time frame
Cervical pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, 1 month, 2 month and 3 month,, The Neck Disability Index (NDI) score (self-administered functional scale, ranging from 0 to 50) at Month 1 and Month 3, and professional status (self-reported: employed, on sick leave, disabled, unemployed, inactive, retired) at Month 1 and Month 3,, The self-administered EQ-5D-5L quality of life scale at Month 1 and Month 3,, Radicular pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, month 2, and month 3,, The occurrence of adverse events (AEs) and serious adverse events (SAEs) at each visit. Surgical intervention will be considered as a SAE, The use of analgesics (levels 1, 2, or 3) since the last visit, using a self-administered 4-level scale (never, several times a month, several times a week, daily) at Day 15, 1, 2 and 3 months post-injection.	—

Measure

Time frame

Cervical pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, 1 month, 2 month and 3 month,, The Neck Disability Index (NDI) score (self-administered functional scale, ranging from 0 to 50) at Month 1 and Month 3, and professional status (self-reported: employed, on sick leave, disabled, unemployed, inactive, retired) at Month 1 and Month 3,, The self-administered EQ-5D-5L quality of life scale at Month 1 and Month 3,, Radicular pain (numeric rating scale, self-administered, ranging from 0 to 100) over the 48 hours preceding Day 15, month 2, and month 3,, The occurrence of adverse events (AEs) and serious adverse events (SAEs) at each visit. Surgical intervention will be considered as a SAE, The use of analgesics (levels 1, 2, or 3) since the last visit, using a self-administered 4-level scale (never, several times a month, several times a week, daily) at Day 15, 1, 2 and 3 months post-injection.

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Outcome results

None listed