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Clinical Trials/NCT02313324
NCT02313324
Completed
Not Applicable

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

Kaohsiung Medical University Chung-Ho Memorial Hospital0 sites42 target enrollmentNovember 2012
ConditionsCoccydynia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coccydynia
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Enrollment
42
Primary Endpoint
Change from pre-enrollment in Visual analog scale (VAS) at 5th and 8th week after first intervention
Status
Completed
Last Updated
11 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
November 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

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)

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