- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02313324
The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial (ESWT)
December 7, 2014 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy (ESWT) on the outcomes of coccydynia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 81 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ESWT group
The patients were randomly assigned to the extracorporeal shock wave therapy (ESWT) group.
|
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.
|
Active Comparator: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
pre-enrollment, 5th and 8th week after first intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
pre-enrollment, 5th and 8th week after first intervention
|
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.
|
8th week after first intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chia-Hsin Chen, MD.PhD, Kaohsiung Municipal Ta-Tung Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
December 3, 2014
First Submitted That Met QC Criteria
December 7, 2014
First Posted (Estimate)
December 10, 2014
Study Record Updates
Last Update Posted (Estimate)
December 10, 2014
Last Update Submitted That Met QC Criteria
December 7, 2014
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- kmutth-101-023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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