Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double‐blind, placebo‐controlled trial

Abstract

Three recent studies demonstrated the positive effect of extracorporeal shock wave therapy (ESWT) for treating carpal tunnel syndrome (CTS). However, none have entirely proved the effects of ESWT on CTS because all studies had a small sample size and lacked a placebo-controlled design. Moreover, radial ESWT (rESWT) has not been used to treat CTS. We conducted a prospective randomized, controlled, double-blinded study to assess the effect of rESWT for treating CTS. Thirty-four enrolled patients (40 wrists) were randomized into intervention and control groups (20 wrists in each). Participants in the intervention group underwent three sessions of rESWT with nightly splinting, whereas those in the control group underwent sham rESWT with nightly splinting. The primary outcome was visual analog scale (VAS), whereas the secondary outcomes included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. Evaluations were performed before treatment and at 1, 4, 8, and 12 weeks after the third rESWT session. A significantly greater improvement in the VAS, BCTQ scores, and CSA of the median nerve was noted in the intervention group throughout the study as compared to the control group (except for BCTQ severity at week 12 and CSA at weeks 1 and 4) (p < 0.05). This is the first study to assess rESWT in a randomized placebo-controlled trial and demonstrate that rESWT is a safe and effective method for relieving pain and disability in patients with CTS. Keywords: extracorporeal shock waves; carpal tunnel syndrome Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy involving the compression of the median nerve in the carpal tunnel. The average prevalence of CTS in the entire population is 3-4%, and it is predominantly observed in females (7% female and 1% male). 1 CTS is characterized by numbness, tingling, pain, or a burning sensation of at least two of the three digits supplied by the median nerve, although thenar muscle atrophy can also occur in the later stages. 2The risk factors for CTS include repetitive wrist stress, obesity, and pregnancy, whereas secondary causes include lesions within the carpal tunnel, metabolic causes, and infection.2 Unlike other progressive diseases, CTS is characterized by remission and recurrence; hence, its prognosis is often uncertain. Although there are many conservative forms of management, such as wrist splint, steroid injections, and therapeutic ultrasound, their effectiveness is typically insignificant or short-lived.3 Moreover, Gerritsen et al. 4 revealed a failure rate of 69% for wrist splinting in patients with CTS after a 12-month follow-up period. Moreover, 60-70% of conservatively treated patients with CTS remained symptomatic after 18 months. Extracorporeal shock waves (ESWs) are defined as a sequence of acoustic pulses characterized by a high peak pressure (100 MPa), fast pressure increase (<10 ns), short duration (...

The dose-dependent efficiency of radial shock wave therapy for patients with carpal tunnel syndrome: a prospective, randomized, single-blind, placebo-controlled trial

“…In order to maintain fundamental care, a wrist night splint was provided for all participants in the three groups since first-session of rESWT. The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist, and participants were informed to wear the splint at night for at least 8 hours during the whole period of this study1117. All participants were instructed to refrain from alternative treatments for the discomfort of CTS including analgesic drugs, acupuncture therapy, manual therapy, ultrasound/laser therapy, or any nonsurgical therapy for CTS, from 1 week prior to participation to the end of the follow-up period.…”

“…The median nerve was identified at the pisiform level of the proximal carpal tunnel, with the palm facing upwards, by one physician using musculoskeletal ultrasonography (Neurotherm NT1000, Neurotherm Inc., USA)112324. rESWT was delivered with the Physio Shock Wave Therapy system (Pagani Elettronica, Milano, Italy)11. The rESWT probe was located and oriented perpendicularly on the median nerve, and treatment comprised 2000 shots at a bar pressure of 4 and a pulse repetition frequency of 5 Hz for each patient11.…”

“…ESWT is classified into focused ESWT (fESWT) and defocused (radial) ESWT (rESWT) based on the design of the reflector for its pressure field and energy. The characteristics of rESWT are less penetrative depth, less focusing of the energy to a targeted spot, and relatively lower intensity compared with fESWT11. ESWT has been extensively clinically applied in treating miscellaneous musculoskeletal disorders like plantar fasciitis, chronic calcifying tendonitis, and lateral epicondylitis1012.…”

“…Recently, both fESWT and rESWT have received increased attention as being a safe and novel therapy for CTS11131415. In 2015, we reported the first prospective, randomized, double-blind, placebo-controlled study, and revealed the effective benefit of rESWT for treating CTS after 3 months follow-up11.…”

“…In 2015, we reported the first prospective, randomized, double-blind, placebo-controlled study, and revealed the effective benefit of rESWT for treating CTS after 3 months follow-up11. However, the evidence for ESWT in CTS from current published studies is not as yet available because of small patient numbers and the lack of a placebo-controlled design in most studies.…”