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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from pre-enrollment in The Oswestry disability index (ODI, in Chinese) at 5th and 8th week after first intervention [ Time Frame: pre-enrollment, 5th and 8th week after first intervention ]
    There are six statements to be ranked on a scale of 0 to 5 in each of the 10 sections of the questionnaire. The contents relate to impairments such as pain intensity and abilities in personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The patients were asked to identify the corresponding level of disability in each section. The total score ranges from 0 to 50; 0 represents the highest level of function, and 50 indicates completely disabled.
  • Change from pre-enrollment in Self-reported satisfaction scales at 8th week after first intervention [ Time Frame: 8th week after first intervention ]
    A 5-level scale was used for evaluation at the 8th week after treatment. The excellent and good scores were categorized into one group, and the acceptable and poor scores were categorized into another group for comparison.


Original Secondary Outcome: Same as current

Information By: Kaohsiung Medical University Chung-Ho Memorial Hospital

Dates:
Date Received: December 3, 2014
Date Started: November 2012
Date Completion:
Last Updated: December 7, 2014
Last Verified: November 2012