Coccydynia
Conditions
Keywords
prolotherapy, coccydynia
Brief summary
In this prospective, randomized, controlled, double-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with coccydynia.
Detailed description
Patients will be informed verbally and in writing about the purpose, duration, and procedure of the study, and their consent will be obtained by signing the "Informed Consent Form." The study aims to evaluate the effectiveness of dextrose prolotherapy applied in coccydynia. The duration of the study is determined to be approximately one year, and it is planned to include 40 patients who will be randomized by a computer program according to the order of application. Patients who meet the inclusion and exclusion criteria will be randomized into two groups. In the first group, in addition to protection recommendations, three sessions of dextrose prolotherapy will be administered at three-week intervals. In the second group, in addition to protection recommendations, three sessions of a superficial saline-lidocaine combination will be administered at three-week intervals. After the application, patients will be questioned for side effects and complications. The effectiveness of dextrose prolotherapy will be evaluated in comparison with the superficial saline-lidocaine combination group. Patients' medical histories will be taken, and demographic characteristics such as age, gender, height, weight, marital status, education level, and occupation will be recorded, along with medical histories such as comorbidities and previous treatments. In the physical examination, lumbar and sacroiliac tests will be applied, the sacrococcygeal region will be palpated, and the average and maximum levels of pain during activity, at rest, and at night will be assessed using the Visual Analog Scale (0-10 points). Functional status will be evaluated using the Paris Functional Coccydynia Questionnaire. Assessments will be conducted before treatment and at the 1st, 3rd, and 6th months after treatment.
Interventions
PROCEDUREDextrose prolotherapy (DPT)
Coccyx injection: Using a sterile 27-gauge syringe (dental needle), a total of 10 cc of solution (5 cc of 30% dextrose + 4 cc of physiological saline + 1 cc of 1% lidocaine solution) will be injected perpendicularly to the surface at the previously marked attachment points of the sacrococcygeal-sacro-tuberous ligaments to the sacrum and along the entire coccyx.
PROCEDUREPhysiological Saline Injection
Saline + lidocaine group injection protocol: Using a sterile 30-gauge syringe (insulin needle), a total of 10 cc of solution (5 cc of physiological saline + 5 cc of 1% lidocaine solution) will be injected into the previously marked tendon attachment points on the bone.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with coccydynia lasting longer than 6 months, * Those unresponsive to at least 6 months of conventional conservative treatment methods, * Those with coccygeal tenderness on palpation, * Patients aged between 18 and 65 years.
Exclusion criteria
* Patients with a history of trauma within the last 3 months or postpartum coccydynia, * Those with lesions or infections at the injection site, * Those with dislocation or organic bone pathology of the coccyx observed on X-ray imaging, * Those with fecal or urinary incontinence, * Patients with poorly controlled diabetes mellitus, * Those with a history of malignancy, * Patients with a bleeding tendency (acquired or hereditary) \[INR \> 2 in patients using warfarin\], * Those with a history of myelomeningocele, * Those diagnosed with spina bifida, * Patients with rheumatologic disease, * Those who have undergone coccyx injection or ganglion block within the last 3 months, * Patients with severe comorbidities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | Before treatment, and at the 1st, 3rd, and 6th months following treatment | Pain intensity during sitting and activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Paris Functional Coccydynia Questionnaire | Before treatment and at the 1st, 3rd, and 6th months after treatment | Functional status assessment |
| Visual Analog Scale-Global Assesment | before treatment, and at the 1st, 3rd, and 6th months following treatment | Daily living activities and patient global assessment |
Countries
Turkey (Türkiye)
Contacts
CONTACTEkin I Sen, Assoc.Prof.
CONTACTSerhat Yavuz
PRINCIPAL_INVESTIGATOREkin I Sen, Assoc.Prof.
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Outcome results
None listed