Neurography verified Carpal tunnel syndrome MedDRA version: 9.1 Level: LLT Classification code 10007697 Term: Carpal tunnel syndrome MedDRA version: 9.1 Level: LLT Classification code 10050127 Term: Electroneurography
Conditions
Interventions
Trade Name: Depo-Medrol
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: METHYLPREDNISOLONE ACETATE
CAS Number: 53361
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Region skåne- Hässleholms sjukvårdsorganisation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Primary, idiopathic CTS ·Age 18-70 years, either gender ·Symptom duration of at least 3 months and inadequate response to wrist splint ·Symptoms of classic or probable CTS according to the diagnostic criteria in Katz hand diagram ·Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities, or in the absence of abnormal nerve conduction study results, 2 surgeons should independently diagnose the patient with CTS. ·Scheduled for carpal tunnel release (ie, symptom severity indicating need for surgery) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Previous steroid injection for CTS in the same wrist ·Inflammatory joint disease, diabetes mellitus ·Vibration-induced neuropathy, polyneuropathy ·Pregnancy ·Trauma to the affected hand in the previous year ·Previous CTS surgery in the affected hand ·Inability to complete questionnaires due to language problem or cognitive disorder ·Severe medical illness ·Known abuse of drugs and/or alcohol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for 10 weeks with outcomes measured with valid standardized outcome instruments. To evaluate rate of surgery at 52,24,12 weeks;Secondary Objective: To assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for at least 52 weeks with outcomes measured with valid standardized outcome instruments. To assess safety of injecting steroid into the carpal tunnel, AE recording during 6 months after periarticular injection;Primary end point(s): Primary endpoint 1.-The score change on the validated CTS symptom severity scale at 10 weeks after treatment. Comparing: 1.high dose vs placebo 2.low dose vs placebo 3.high dose vs low dose 2.-Rate of surgery in rank order 52,24,12 weeks after treatment Comparing: 1.high dose vs placebo 2.low dose vs placebo 3.high dose vs low dose | — |
Countries
Sweden
Outcome results
None listed