Clinical trial NCT02313324: The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial
Official title: The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coccydynia
Keywords: Coccydynia
Extracorporeal shock wave therapy
Disability
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from pre-enrollment in Visual analog scale (VAS) at 5th and 8th week after first intervention
timeFrame: pre-enrollment, 5th and 8th week after first intervention
Secondary outcomes:
measure: Change from pre-enrollment in The Oswestry disability index (ODI, in Chinese) at 5th and 8th week after first intervention
timeFrame: pre-enrollment, 5th and 8th week after first intervention
measure: Change from pre-enrollment in Self-reported satisfaction scales at 8th week after first intervention
timeFrame: 8th week after first intervention
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Municipal Ta-Tung Hospital
name: Chia-Hsin Chen, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin SF, Chen YJ, Tu HP, Lee CL, Hsieh CL, Wu WL, Chen CH. The Effects of Extracorporeal Shock Wave Therapy in Patients with Coccydynia: A Randomized Controlled Trial. PLoS One. 2015 Nov 10;10(11):e0142475. doi: 10.1371/journal.pone.0142475. eCollection 2015.