The Effect of Therapeutic Ultrasound on Pain in Coccydynia

NCT05142930 | Unknown

• 1 other identifier: 2021-02/29
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Pain of the sacrococcygeal region is called coccydynia This painful clinical picture, which causes a decrease in the quality of life, also causes disability. Physical therapy modalities are used in the treatment of coccydynia. Ultrasound, which is used for diagnostic and therapeutic purposes, can be applied in two ways as continuous and intermittent for therapeutic purposes.Our aim in this study is to compare the effectiveness of continuous and intermittent ultrasound in patients with a diagnosis of coccydynia and to examine its effect on pain.

Conditions

Coccyx Disorder

Keywords

coccyx; pain; ultrasonic waves

Outcome Measures

Primary Outcomes (4)

• Pain Severity

  Visual Analog scale (VAS) will be used to determine the pain severity of patients.

  Change of VAS between baseline and at 3 weeks

• Pain Severity

  Visual Analog scale (VAS) will be used to determine the pain severity of patients.

  Change of VAS between baseline and at 3 months

• Disability

  Disability assessment will be made using the Owstery Disability Index. The scale consists of 10 items in total. Each item is graded between 0-5. As the total score increases, the level of disability increases. The maximum score is 50 points. The total score obtained from the patient will be converted into the percentage system and the disability percentage will be calculated and evaluated.

  Change of Owstery Disability Index between baseline and at 3 weeks

• Disability

  Disability assessment will be made using the Owstery Disability Index. The scale consists of 10 items in total. Each item is graded between 0-5. As the total score increases, the level of disability increases. The maximum score is 50 points. The total score obtained from the patient will be converted into the percentage system and the disability percentage will be calculated and evaluated.

  Change of Owstery Disability Index between baseline and at 3 months

Study Arms (2)

Intermittent ultrasound

ACTIVE COMPARATOR

Patients with coccydynia will receive 10 sessions of physical therapy, 5 days a week for 2 weeks. Intermittent ultrasound will be used as a physical therapy agent. Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region at a dose of 1.0W/cm², at a frequency of 1 Megahertz, for 3+3 minutes.

Other: Intermittent ultrasound

Continuous ultrasound

ACTIVE COMPARATOR

Patients with coccydynia will receive 10 sessions of physical therapy, 5 days a week for 2 weeks. Continuous ultrasound will be used as a physical therapy agent. Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region at a dose of 1.0W/cm², at a frequency of 1 Megahertz, for 3+3 minutes.

Other: Continuous ultrasound

Interventions

Intermittent ultrasound OTHER

Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region

Intermittent ultrasound

Continuous ultrasound OTHER

Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region

Continuous ultrasound

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with coccydynia and having idiopathic or trauma history in etiology
• years old
• The patient's acceptance of the ultrasound treatment to be applied
• Being in good mental health in terms of compliance with the treatment to be applied
• Receiving conservative treatment before ultrasound treatment
• The patient's numerical pain scale must be 5 and above

You may not qualify if:

• Being under the age of 18 and over the age of 75
• The patient's refusal to accept the treatment
• Wound or soft tissue infection in the skin area to be treated
• Pregnant patients
• Patients who have been diagnosed with malignancy

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Haghighat S, Mashayekhi Asl M. Effects of Extracorporeal Shock Wave Therapy on Pain in Patients With Chronic Refractory Coccydynia: A Quasi-Experimental Study. Anesth Pain Med. 2016 Jun 1;6(4):e37428. doi: 10.5812/aapm.37428. eCollection 2016 Aug.

  PMID: 27843777 BACKGROUND

Related Links

• Effect of extracorporeal shock wave therapy on coccydynia

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emel Güler, MD

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emel Güler, MD

CONTACT

+905356492951; dremelguler@gmail.com

Özhan Pazarcı, MD

CONTACT

+903224559000; dr.pazarci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel groups will be received different treatment modalities

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 3, 2021
• Study Start: April 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)