The Effect of Therapeutic Ultrasound on Pain in Coccydynia

• Sponsor: Cumhuriyet University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05142930
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coccyx Disorder	Other: Intermittent ultrasound; Other: Continuous ultrasound	N/A

Detailed Description

Coccygodynia often develops from an inappropriate sitting position or when standing up from a sitting position. In the advanced stages of coccydynia, the pain becomes continuous. Conservative treatment, interventional procedures and surgical treatment are used in treatment. Medical treatment, physical therapy and local injection applications are accepted as conservative treatment methods.Among the physical therapy modalities, ultrasound has been used for many years in diseases affecting the musculoskeletal system. Ultrasound, which is used for diagnostic and therapeutic purposes, can be applied in two ways as continuous and intermittent for therapeutic purposes.

A total of 52 patients who applied between 01/04/2021 and 01/04/2022 and met the inclusion and exclusion criteria will be included in the study. Continuous ultrasound will be performed in 26 patients and intermittent ultrasound will be performed in 26 patients. Randomization will be determined by the treatment protocol prepared in closed envelopes.Within the scope of the study, the age, height, weight, trauma history, duration of complaint, severity of pain and Oswestry Disability Index scale will be recorded before the interventions. The patients will be followed up at the 3rd week and 3rd month after the treatment. The Oswestry Disability Index scale will be filled in to assess the severity of disability resulting from pain in the patient. Pain severity will be evaluated with the Visual Analog Scale (VAS).

Data will be entered into SPSS (version: 22.0) IBM SPSS statistical package program. Arithmetic mean, standard deviation, min-max, median values will be given in the data obtained by measurement. Percentage and frequency distribution will be given in the data obtained by counting. In statistical evaluations, parametric tests will be used for data showing normal distribution, and non-parametric tests will be used for data not showing normal distribution. Relationships will be compared according to the Pearson or Spearman correlation coefficient. Chi-square test will be applied to categorical data. P<0.05 will be considered significant.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel groups will be received different treatment modalitiesParallel groups will be received different treatment modalities
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Therapeutic Ultrasound on Pain in Coccydynia
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intermittent ultrasound 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; Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region
Active Comparator: Continuous ultrasound 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; Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region

Outcome Measures

Primary Outcome Measures

1. Pain Severity [Change of VAS between baseline and at 3 weeks]

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

2. Pain Severity [Change of VAS between baseline and at 3 months]

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

3. Disability [Change of Owstery Disability Index between baseline and at 3 weeks]

   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.

4. Disability [Change of Owstery Disability Index between baseline and at 3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with coccydynia and having idiopathic or trauma history in etiology

• 18-75 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sivas Cumhuriyet University	Sivas		Turkey	58140

Sponsors and Collaborators

• Cumhuriyet University

Investigators

• Principal Investigator: Emel Güler, MD, Cumhuriyet University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Effect of extracorporeal shock wave therapy on coccydynia

Publications

• 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. eCollection 2016 Aug.

• Responsible Party: Emel Güler, Associate Professor, Cumhuriyet University
• ClinicalTrials.gov Identifier: NCT05142930
• Other Study ID Numbers: 2021-02/29
• First Posted: Dec 3, 2021
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Emel Güler, Associate Professor, Cumhuriyet University: coccyx; pain; ultrasonic waves

Study Results

No Results Posted as of Dec 3, 2021