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Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial.

ABSTRACT: OBJECTIVE:The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome. METHODS:The study included 46 carpal tunnel syndrome patients who were randomly divided into 3 groups. The first group (n?=?15) received a 0 W/cm2 ultrasound treatment (placebo); the second group (n?=?16) received a 1.0 W/cm2 continuous ultrasound treatment and the third group (n?=?15) received a 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients also wore night splints during treatment period. Pre-treatment and post-treatment Visual Analogue Scale, Symptom Severity Scale and Functional Status Scale scores, median nerve motor conduction velocity and distal latency and sensory conduction velocities of the median nerve in the 2nd finger and palm were compared. Clinicaltrials.gov: NCT02054247. RESULTS:There were significant improvements in all groups in terms of the post-treatment Functional Status Scale score (p<0.05 for all groups), Symptom Severity Scale score (first group: p<0.05, second group: p<0.01, third group: p<0.001) and Visual Analogue Scale score (first and third groups: p<0.01, second group: p<0.001). Sensory conduction velocities improved in the second and third groups (p<0.01). Distal latency in the 2nd finger showed improvement only in the third group (p<0.01) and action potential latency in the palm improved only in the second group (p<0.05). CONCLUSION:The results of this study suggest that splinting therapy combined with placebo and pulsed or continuous ultrasound have similar effects on clinical improvement. Patients treated with continuous and pulsed ultrasound showed electrophysiological improvement; however, the results were not superior to those of the placebo.

SUBMITTER: Armagan O

PROVIDER: S-EPMC4129559 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial.

Armagan Onur O Bakilan Fulya F Ozgen Merih M Mehmetoglu Ozlem O Oner Setenay S

Clinics (Sao Paulo, Brazil) 20140801 8

<h4>Objective</h4>The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome.<h4>Methods</h4>The study included 46 carpal tunnel syndrome patients who were randomly divided into 3 groups. The first group (n = 15) received a 0 W/cm2 ultrasound treatment (placebo); the second group (n = 16) received a 1.0 W/cm2 continuous ultrasound treatment an ...[more]

PMID: 25141110

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Project description:Background: Despite the wide use of corticosteroid hydrodissection for carpal tunnel syndrome (CTS), there is insufficient evidence to confirm its efficacy. This study aimed to compare the effectiveness of corticosteroid hydrodissection vs. corticosteroid perineural injection alone on clinical and electrophysiological parameters in patients with CTS. Method: This prospective randomized controlled trial (RCT) was conducted in a tertiary care center with a follow-up period of 12 weeks. Subjects were randomly assigned to either ultrasound-guided hydrodissection with a mixture of 1 mL of triamcinolone acetonide (10 mg/mL), 1 mL of 2% lidocaine, and 8 mL normal saline or ultrasound-guided perineural injection with 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of 2% lidocaine. The primary outcome measure was the symptom severity subscale (SSS) of Boston Carpal Tunnel Questionnaire (BCTQ) scores at baseline and at 6 and 12 weeks' post-treatment. The secondary outcomes included the functional status subscale (FSS) of BCTQ and the distal motor latency and sensory nerve conduction velocity of the median nerve. The effect of interventions on the designated outcome was analyzed using a 3 × 2 repeated measures analysis of variance. The within-subject and among-subject factors were differences in time (before the intervention, and 6 and 12 weeks after injection) and intervention types (with or without hydrodissection), respectively. Results: Sixty-four patients diagnosed with CTS were enrolled. Both groups experienced improvement in the SSS and FSS of BCTQ and median nerve distal motor latency and sensory nerve conduction velocity. However, group-by-time interactions were not significant in any outcome measurements. No serious adverse events were reported in either group, except for two patients in the hydrodissection group who reported minor post-injection pain on the first day after the intervention, which resolved spontaneously without the need for additional treatments. Conclusion: Hydrodissection did not provide an additional benefit compared to corticosteroid perineural injection alone. More prospective studies are needed to investigate the long-term effectiveness of corticosteroid hydrodissection, as well as its influence on median nerve mobility.

Project description:BACKGROUND:Carpal tunnel syndrome (CTS) is a common cause of pain, weakness, sensory loss, and activity limitations. Currently, the most common initial treatment is use of a rigid splint immobilizing the wrist, usually during night-time, for several weeks. Evidence regarding the efficacy and effect durability of wrist splinting is weak. The treatment is associated with costs and may cause discomfort and limit daily and work activities. No placebo-controlled trials have been performed. METHODS:This is a randomized controlled trial designed to assess the efficacy of a rigid wrist splint compared with soft wrist bandage (placebo) in patients with primary idiopathic CTS. The trial will be conducted at an orthopedic department. Patients, 25 to 65 years old, who seek primary health-care with symptoms of CTS will be screened, and potentially eligible patients will be referred to the study center. Patients who fulfill the trial's eligibility criteria will be invited to participate. A total of 112 patients who provide informed consent will be randomly assigned to treatment with either a rigid wrist splint or a soft bandage to be used initially for 6 weeks at night and, if possible, during the day. The splints and bandages will be fitted with a temperature-monitoring device to measure the total time during which they have actually been worn. The trial participants will complete a questionnaire that includes the 6-item CTS symptoms scale (CTS-6); the 11-item disabilities of the arm, shoulder, and hand (QuickDASH) scale; and the EuroQol 5-dimension (EQ-5D) health status and quality-of-life measure at baseline and at 6, 12, 24, and 52 weeks after treatment start. The participants will undergo physical examination and nerve conduction testing at baseline and at 52 weeks. The trial's primary outcomes are the change in the CTS-6 score from baseline to 12 weeks and the rate of carpal tunnel release surgery at 52 weeks. DISCUSSION:This is the first placebo-controlled randomized trial with electronic monitoring of actual splint use and will provide evidence regarding the efficacy of wrist splinting in patients with CTS. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN81836603 . Registered on May 5, 2018.

Project description:BackgroundCarpal tunnel syndrome (CTS) is the most common form of peripheral nerve injury, affecting approximately 3 % of the population. While surgery is effective in mild and moderate cases, nerve and functional recovery are often not complete in severe cases. Therefore, there is a need for adjuvant methods to improve nerve regeneration in those cases. Acetyl-L-carnitine (ALCAR) is involved in lipid transport, vital for mitochondrial function. Although it has been shown to be effective in various forms of neuropathies, it has not been used in traumatic or compressive peripheral nerve injury.MethodsIn this pilot study we will utilize a double-blind, randomized, placebo-controlled design. Inclusion criteria will include adult patients with severe CTS. This will be confirmed by nerve conduction studies and motor unit number estimation (MUNE). Only those with severe motor unit loss in the thenar muscles (2 standard deviations [SD] below the mean for the age group) will be included. Eligible patients will be randomized to receive 3,000 mg/day of ALCAR orally or placebo following carpal tunnel release surgery for 2 months. The primary outcome will be MUNE with supplementary secondary outcome measures that include: 1) two-point discrimination; 2) Semmes-Weinstein monofilaments for pressure sensitivity; 3) cold and pain threshold for small fiber function; 4) Boston self-assessment Carpal Tunnel Questionnaire and 5) Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire for symptom severity; and 6) Purdue Pegboard Test for hand functional performance. To follow post treatment recovery and monitor safety, patients will be seen at 3 months, 6 months and 1 year. The outcome measures will be analyzed using two-way ANOVA, with treatment assignment and time points being the independent factors. If significant associations are detected, a post hoc analysis will be completed. We aim to recruit ten patients into each of the two groups. Data from this pilot will provide the basis for power calculation for a full-scale trial.DiscussionALCAR is a physiologic peptide crucial for fatty acid transport. ALCAR has been shown to be effective in neuroprotection in the central nervous system and increase peripheral nerve regeneration. This has been applied clinically to various systemic peripheral neuropathies including diabetic neuropathy, antiretroviral toxic neuropathy, and chemotherapy-induced peripheral neuropathy. While animal evidence exists for the benefit of ALCAR in compression neuropathy, there have been no human studies to date. This trial will represent the first use of ALCAR in peripheral nerve injury/compression neuropathy.Trial registrationNCT02141035 ; 20 April 2015.

Dataset Information

Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial.

Publications

Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial.

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