Clinical Trials Directory

Trials / Completed

CompletedNCT02313324

The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
Sex
All
Age
20 Years – 83 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy (ESWT) on the outcomes of coccydynia.

Detailed description

Coccydynia is pain in the coccygeal region, and usually treated conservatively. Extracorporeal shock wave therapy (ESWT) was incorporated as non-invasive treatment of many musculoskeletal conditions. However, the effects of ESWT on coccydynia are less discussed. The purpose of this study is to evaluate the effects of ESWT on the outcomes of coccydynia. Patients were allocated to ESWT (n=20) or physical modality (SIT) group (n=21) randomly, and received total treatment duration of 4 weeks. The visual analog scale (VAS), Oswestry disability index (ODI), and self-reported satisfaction score were used to assess treatment effects. The VAS and ODI scores were significantly decreased after treatment in both groups, and the decrease in the VAS score was significantly greater in the ESWT group. The mean proportional changes in the ODI scores were greater in the ESWT group than in the SIT group, but the between-group difference was not statistically significant. The patients in the ESWT group had significantly higher subjective satisfaction scores than SIT group. The investigators concluded that ESWT is more effective and satisfactory in improving discomfort and disability caused by coccydynia than the use of physical modalities. Thus, ESWT is recommended as an optimal treatment option for patients with coccydynia.

Conditions

Interventions

TypeNameDescription
DEVICEExtracorporeal shock wave therapy (ESWT)The patients received 2000 shots of extracorporeal shock wave therapy in the coccyx area per session for four sessions (one session a week for 4 consecutive weeks). The frequency used was 5 Hz and the pressure was 3-4 bar.
DEVICESWD combined IFCThe shortwave diathermy (SWD) was the inductive mode with a coil at a frequency of approximately 27.12 MHz. The shortwave diathermy applicator was placed over the sacrococcygeal area. The treatment duration was 20 minutes. After completing the SWD treatments, the patients received the interferential current (IFC) treatment. IFC provides deeper electrical stimulation. The electrical current was applied to the gluteal area using four electrodes from 2 channels of the stimulator. The four electrodes were set on the gluteal area. The carrier frequency, typically 4000 Hz and 4100 Hz and designed to interfere with each other, resulted in a beat frequency of 100 Hz within the treated area. The treatment duration was 20 minutes. The protocol was set as 3 times per week for a period of 4 weeks.

Timeline

Start date
2012-11-01
Primary completion
2013-11-01
Completion
2013-11-01
First posted
2014-12-10
Last updated
2014-12-10

Source: ClinicalTrials.gov record NCT02313324. Inclusion in this directory is not an endorsement.