Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: Protocol of a randomized double-blind placebo-controlled trial (NCT 00806871)

<p>Abstract</p> <p>Background</p> <p>Patients with idiopathic carpal tunnel syndrome (CTS) are commonly treated with steroid injection into or proximal to the carpal tunnel. However, evidence for its efficacy beyond one month has not been established in randomized placebo-controlled trials. The primary aim of this randomized trial is to assess the efficacy of steroid injection into the carpal tunnel in relieving symptoms of CTS in patients with symptoms of such severity to warrant surgical treatment but have not been treated with steroid injection.</p> <p>Methods/Design</p> <p>The study is a randomized double-blind placebo-controlled trial. Patients referred to one orthopedic department because of CTS are screened. Eligibility criteria are age 18 to 70 years, clinical diagnosis of primary idiopathic CTS and abnormal nerve conduction tests or clinical diagnosis made independently by two orthopedic surgeons, failed treatment with wrist splinting, symptom severity of such magnitude that the patient is willing to undergo surgery, no severe sensory loss or thenar muscle atrophy, and no previous steroid injection for CTS. A total of 120 patients will be randomized to injection of 80 mg Methylprednisolone, 40 mg Methylprednisolone, or normal saline, each also containing 10 mg Lidocaine. Evaluation at baseline and at 5, 10, 24 and 52 weeks after injection includes validated questionnaires (CTS symptom severity scale, <it>Quick</it>DASH and SF-6D), adverse events, physical examination by a blinded assessor, and nerve conduction tests. The primary outcome measures are change in the CTS symptom severity score at 10 weeks and the rate of surgery at 52 weeks. The secondary outcome measures are the score change in the CTS symptom severity scale at 52 weeks, time to surgery, and change in <it>Quick</it>DASH and SF-6D scores and patient satisfaction at 10 and 52 weeks. The primary analysis will be carried out using mixed model analysis of repeated measures.</p> <p>Discussion</p> <p>This paper describes the rationale and design of a double-blind, randomized placebo-controlled trial that aims to determine the efficacy of two different doses of steroid injected into the carpal tunnel in patients with moderately severe idiopathic CTS.</p> <p>Trial registration</p> <p>Clinicaltrials.gov identifier NCT00806871</p

Cerebral and clinical effects of short-term hand immobilisation.

In this work, functional changes in the sensorimotor cortex following unilateral hand immobilisation were investigated in 11 healthy volunteers. Sensory and motor function of both hands was also assessed. Cortical activation was monitored with functional magnetic resonance imaging at 3 T. All examinations were performed prior to and directly after 72 h of immobilisation of the dominant hand and wrist. Following unilateral immobilisation, cortical activation increased substantially during tactile stimulation of the non-immobilised hand. This was particularly evident in the ipsilateral somatosensory cortex. Additionally, a redistribution of hemispheric dominance towards zero lateralisation was seen. A bilateral cortical activation increase was also seen during performance of a finger-tapping task by the non-immobilised hand, although this increase was less prominent than during tactile stimulation. In contrast, performance of the finger-tapping task with the immobilised hand resulted in an activation decrease, predominantly in the ipsilateral sensorimotor cortex. This site was anatomically close to the regional activation increase of the non-immobilised hand. These functional changes were associated with reduced grip strength, dexterity and tactile discrimination of the immobilised hand, and simultaneously improved tactile discrimination of the non-immobilised hand. This suggests that brain adaptation following hand immobilisation includes inter-hemispheric dynamics. In summary, the improved sensory function of the non-immobilised hand following unilateral immobilisation is associated with cortical expansion, predominantly contralateral to the immobilised hand, and a redistribution of hemispheric dominance. Both cortical and clinical effects of immobilisation were identified after 72 h, suggesting rapid inter-hemispheric plasticity using existing neural substrates

Carpal tunnel syndrome treated with guided brain plasticity : a randomised, controlled study

Introduction: Guided plasticity, induced by cutaneous forearm anaesthesia, improves hand sensibility in patients with nerve injury and vibration-induced neuropathy. This study investigated whether patients with carpal tunnel syndrome (CTS) would benefit from cutaneous forearm anaesthesia. Methods: Seventy patients with clinical and electroneurography-verified CTS were randomised to sensory training combined with either an anaesthetic cream (EMLA®) (n = 34) or a placebo cream (n = 36) on the volar part of the forearm. The treatment was repeated at increasing intervals over 8 weeks. The primary outcome was the Boston carpal tunnel questionnaire (BCTQ) symptom severity scale after 8 weeks. Secondary outcomes included activity limitations, sensory function, and nerve conduction. This study compared the longitudinal changes between the two groups, and with correction for multiple comparisons it also compared the longitudinal change within the groups. Results: There were no significant differences in primary or secondary outcomes between the groups. However, the BCTQ symptom severity scale improved significantly within the EMLA® group over the 8-week period (p = 0.001). Apart from this, no significant improvements in activity limitations, sensory function, or nerve conduction were seen in the two groups compared to baseline. Altogether, 47% of patients in the EMLA® group and 61% in the placebo group had been operated on with carpal tunnel release by 12 months. Conclusion: An 8-week treatment protocol with cutaneous forearm anaesthesia to guide brain plasticity gave no significant subjective or objective improvements in hand function compared to placebo

Short-Term Outcomes of Trapeziometacarpal Artelon Implant Compared With Tendon Suspension Interposition Arthroplasty for Osteoarthritis: A Matched Cohort Study.

PURPOSE: To compare the short-term efficacy of the Artelon trapeziometacarpal (TMC) implant with that of total trapeziectomy and abductor pollicis longus (APL) tendon suspension interposition arthroplasty in TMC osteoarthritis. METHODS: A single-center matched cohort study was designed. The Artelon cohort comprised 13 consecutive patients (10 women, 3 men; mean age, 54 years) operated on with Artelon implant arthroplasty. The APL cohort comprised 40 patients (33 women, 7 men; mean age, 58 years) randomly selected among 88 consecutive age-matched patients operated on with APL arthroplasty during the same period. The mean follow-up time was 13 (SD, 4) months for the Artelon group and 12 (SD, 3) months for the APL group. All patients completed the short-form Disabilities of the Arm, Shoulder, and Hand (QuickDASH) survey and a scale measuring thumb pain and related activity limitation, both scored 0 (best) to 100 (worst). Patient satisfaction was recorded. Physical examination was performed by a blinded therapist. RESULTS: The median QuickDASH score was 25 for the Artelon group and 20 for the APL group; the median pain scores were 38 and 28, respectively; the differences were not statistically significant. In the Artelon group, 8 patients were satisfied, compared with 32 in the APL group; the adjusted odds ratio of not being satisfied following Artelon implant compared to APL arthroplasty was 4. The median grip strength as a percentage of the contralateral hand was 82% in the Artelon group and 95% in the APL group; the median pinch strength was 61% and 86%, respectively. No statistically significant differences were found in thumb palmar or radial abduction. Two Artelon patients had revision to APL arthroplasty. CONCLUSIONS: The short-term outcomes of the Artelon TMC implant were not superior to those of tendon suspension interposition arthroplasty, a factor to be considered when comparing treatment cost effectiveness. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic III