Clinical trial NCT05142930: The Effect of Therapeutic Ultrasound on Pain in Coccydynia
Official title: The Effect of Therapeutic Ultrasound on Pain in Coccydynia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coccyx Disorder
Keywords: coccyx
pain
ultrasonic waves
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups will be received different treatment modalities
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Severity
timeFrame: Change of VAS between baseline and at 3 weeks
measure: Pain Severity
timeFrame: Change of VAS between baseline and at 3 months
measure: Disability
timeFrame: Change of Owstery Disability Index between baseline and at 3 weeks
measure: Disability
timeFrame: Change of Owstery Disability Index between baseline and at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Cumhuriyet University
name: Emel Güler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.