CoccydyniaESWTNCT02313324
The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial
A study testing Extracorporeal shock wave therapy (ESWT) and SWD combined IFC in people with Coccydynia, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy (ESWT) on the outcomes of coccydynia. Read more about this study
- Who is it for?
- Ages 20 to 83 years
- Conditions the study is for
- Coccydynia
- What is being tested?
- Extracorporeal shock wave therapy (ESWT) and SWD combined IFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time diagnosed with coccydynia
- History of direct traumatic events to the buttocks, such as falls or slipping
Who cannot join
- Tumors of the cauda equina
- Pelvic surgery
- Herniation of the lumbosacral disc
- Internal procidentia
- Genitourinary or gastrointestinal complaints
- Psychogenic factors
About this study
The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy (ESWT) on the outcomes of coccydynia.
Read the 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.
- Conditions
- Coccydynia
- Being tested
- Extracorporeal shock wave therapy (ESWT), SWD combined IFC
- Keywords
- Coccydynia, Extracorporeal shock wave therapy, Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapy (ESWT)Device
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.
SWD combined IFCDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ESWT group | Experimental | The patients were randomly assigned to the extracorporeal shock wave therapy (ESWT) group. Receives: Device: Extracorporeal shock wave therapy (ESWT) |
| SWD combined IFC group | Active comparator | 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. Receives: Device: SWD combined IFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pre-enrollment in Visual analog scale (VAS) at 5th and 8th week after first intervention
a scale from 0 through 100 (0 for no pain and 100 for the worst pain)
Measured: pre-enrollment, 5th and 8th week after first intervention
Secondary outcomes (2)
Change from pre-enrollment in The Oswestry disability index (ODI, in Chinese) at 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.
Measured: pre-enrollment, 5th and 8th week after first intervention
Change from pre-enrollment in Self-reported satisfaction scales at 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.
Measured: 8th week after first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startNov 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoccydyniaStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hsin Chen, MD.PhD, Principal investigator, Kaohsiung Municipal Ta-Tung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313324
- Sponsor's protocol ID
- kmutth-101-023
- Acronym
- ESWT
- Status last verified
- Nov 2012
- First submitted
- 3 Dec 2014
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26556601
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02313324
- Acronym / sponsor ID
- ESWT / kmutth-101-023
- Conditions
- Coccydynia
- Keywords
- Coccydynia, Extracorporeal shock wave therapy, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT group | Experimental | Device: Extracorporeal shock wave therapy (ESWT)The patients were randomly assigned to the extracorporeal shock wave therapy (ESWT) group. |
| SWD combined IFC group | Active comparator | Device: SWD combined IFCThe 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. |
Who may qualify
- Ages
- 20 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First-time diagnosed with coccydynia
- History of direct traumatic events to the buttocks, such as falls or slipping
Key exclusion criteria (6 listed)
- Tumors of the cauda equina
- Pelvic surgery
- Herniation of the lumbosacral disc
- Internal procidentia
- Genitourinary or gastrointestinal complaints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wave therapy (ESWT)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. | Device | ESWT group |
| SWD combined IFCThe 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. | Device | SWD combined IFC group |
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)
2 secondary outcomes
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
Change from pre-enrollment in Self-reported satisfaction scales at 8th week after first intervention
Time frame: 8th week after first intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Derived from this study: PubMed 26556601Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hsin Chen, MD.PhD principal investigator
Kaohsiung Municipal Ta-Tung Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy (ESWT) and SWD combined IFC in people with Coccydynia, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02313324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.