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

NCT02313324 | Completed DMC

• 1 other identifier: kmutth-101-023
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Coccydynia

Keywords

Coccydynia; Extracorporeal shock wave therapy; Disability

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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

Study Arms (2)

ESWT group

EXPERIMENTAL

The patients were randomly assigned to the extracorporeal shock wave therapy (ESWT) group.

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.

Device: SWD combined IFC

Interventions

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.

ESWT group

SWD combined IFC DEVICE

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.

SWD combined IFC group

Eligibility Criteria

• Age: 20 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time diagnosed with coccydynia
• History of direct traumatic events to the buttocks, such as falls or slipping

You may not qualify if:

• Tumors of the cauda equina
• Pelvic surgery
• Herniation of the lumbosacral disc
• Internal procidentia
• Genitourinary or gastrointestinal complaints
• Psychogenic factors

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Related Publications (1)

• 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.

  PMID: 26556601 DERIVED

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Chia-Hsin Chen, MD.PhD

  Kaohsiung Municipal Ta-Tung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 10, 2014
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 10, 2014

Record last verified: 2012-11