Phase 4 N=111 Randomized Quadruple-blind Treatment

Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02652390 ↗

Enrolled (actual)

111

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand — 31; 34; 36 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Methylprednisolone 80 mg (Drug); Methylprednisolone 40 mg (Drug); Saline (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Region Skane
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand	31; 34; 36	—
PRIMARY Symptom Severity Score	1.34; 1.53	—
SECONDARY Palmar Pain Score	86.4; 84.6; 83.0	—
SECONDARY 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score	13.1; 16.9; 19.3	—
SECONDARY Bodily Pain Score	81.4; 79.9; 78.2	—
SECONDARY Satisfaction Score	77.5; 71.4; 68.4	—

Summary

Between 2008 and 2012 the investigators performed a single-center randomized double-blind placebo-controlled trial to assess the efficacy of local injection of two different doses of methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18 to 70 years, not previously treated with steroid injection. The primary outcomes were change in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3 groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.

Eligibility Criteria

Inclusion Criteria

Primary idiopathic CTS
Symptoms of classic or probable CTS according to the Katz diagnostic criteria (numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers)
Failed treatment with wrist splinting (2 months)
Nerve conduction tests showing median neuropathy at the wrist or, if normal, two orthopedic surgeons independently make CTS diagnosis
Symptom severity that warranted referral for consideration for surgery

Exclusion Criteria

Previous steroid injection for CTS
Thenar muscle atrophy
Sensory deficit (two-point discrimination >8 mm)
Diabetes, thyroid disorder, or inflammatory disease
Polyneuropathy or vibration-induced neuropathy
Current pregnancy
Previous carpal tunnel surgery on the study hand
Surgery on the contralateral hand in the past 2 months
Inability to respond to questionnaires
Severe medical illness
Known drug/alcohol abuse

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02652390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.