The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Primary Endpoint
- Change from pre-enrollment in Visual analog scale (VAS) at 5th and 8th week after first intervention
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 83 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •First-time diagnosed with coccydynia
- •History of direct traumatic events to the buttocks, such as falls or slipping
Exclusion Criteria
- •Tumors of the cauda equina
- •Pelvic surgery
- •Herniation of the lumbosacral disc
- •Internal procidentia
- •Genitourinary or gastrointestinal complaints
- •Psychogenic factors
Arms & Interventions
ESWT group
The patients were randomly assigned to the extracorporeal shock wave therapy (ESWT) group.
Intervention: Extracorporeal shock wave therapy (ESWT) (Device)
SWD combined IFC group
The patients were randomly assigned to the SIT group. The patients received combined therapy with shortwave diathermy (SWD) and interferential current (IFC) performed by the same physiotherapist at each treatment session.
Intervention: SWD combined IFC (Device)
Outcomes
Primary Outcomes
Change from pre-enrollment in Visual analog scale (VAS) at 5th and 8th week after first intervention
Time Frame: pre-enrollment, 5th and 8th week after first intervention
a scale from 0 through 100 (0 for no pain and 100 for the worst pain)
Secondary Outcomes
- Change from pre-enrollment in The Oswestry disability index (ODI, in Chinese) at 5th and 8th week after first intervention(pre-enrollment, 5th and 8th week after first intervention)
- Change from pre-enrollment in Self-reported satisfaction scales at 8th week after first intervention(8th week after first intervention)