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
| Type | Name | Description |
|---|---|---|
| DEVICE | Extracorporeal 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. |
| DEVICE | SWD combined IFC | The 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.