A phase IV single-blind placebo-controlled cross-over study to investigate the efficacy of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine.

INTERVENTION: Trade Name: Lidocaine 2% Product Name: 2% Lidocaine Product Code: N/A Pharmaceutical Form: Injection INN or Proposed INN: Lidocaine CAS Number: 137‐58‐6 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Subcutaneous use Trade Name: Depo‐Medrone Product Name: Methylprednisolone Product Code: 18157/0227 Pharmaceutical Form: Injection INN or Proposed INN: Methylprednisolone CAS Number: 83432 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Subcutaneous use CONDITION: Chronic migraine ; MedDRA version: 18.0 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 100000004852 Therapeutic area: Body processes [G] ‐ Bones and nerves physological processes [G11] PRIMARY OUTCOME: Main Objective: The primary objective of this study, is to investigate any change in disability associated with chronic migraine disorder in the two treatment arms (greater occipital nerve block versus placebo procedure).; Primary end point(s): The primary outcome being measured in this study is improvement in disability associated with chronic migraine disorder as assessed by: ; • Change in the Headache Impact Test (HIT‐6) questionnaire score; • Change in the Migraine‐Specific Questionnaire (MSQ) score ; • Change in the 12‐item Short Form Health Survey (SF‐12) questionnaire score Secondary Objective: a. To assess change in participant headache frequency and severity, ; b. To assess the change in participant anxiety and depression levels, ; c. To assess the safety and tolerability in the two treatment arms.; d. To assess the eligibility criteria, recruitment and retention of participants in the two treatment arms.; e. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams.; ; Timepoint(s) of evaluation of this end point: Baseline; 4 weeks post treatment; 8 weeks post treatment; 12 weeks post treatment; * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).; ; Cross over; 4 weeks post treatment; 8 weeks post treatment; 12 weeks post treatment; * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner). INCLUSION CRITERIA: 1.Age over 18 and ability to provide written consent. 2.Diagnosis of chronic migraine with or without acute relief medication overuse (ICHD‐II codes 1.5.1 and 1.6.5); as confirmed by diary documentation (headache on 15 or more days a month for at least 3 months). 3.Ability to read and write English (questionnaire use in the study) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0 SECONDARY OUTCOME: Secondary end point(s): The secondary objectives are to assess:; a. change in headache characteristics: frequency & severity (HIT‐6 score) ; b. change in anxiety and depression (HAD scores); c. safety of intervention (SAR/SAE reports); d. tolerability (SAR/SAE reports); e. economic outcomes ; f. eligibility criteria, recruitment and retention of patients in the two treatment arms (recruitment and retention rates).; g. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams (questionnaire upon completion of study and feedback from clinicians regarding overall feasibility/acceptability of the two treatment arms).; ; Timepoint(s) of evaluation of this end point: Baseline; 4 weeks post treatment; 8 weeks post treatment; 12 weeks post treatment; * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).; Cross over; 4 weeks post treatment; 8 weeks post treatment; 12 weeks post treatment; * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).