The Effectiveness of Dextrose Prolotherapy in Patients With Coccydynia

Обзор

In this prospective, randomized, controlled, double-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with coccydynia.

Подробное описание

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.

Вмешательства

• Процедура Dextrose 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.
• Процедура Physiological 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.

Первичные конечные точки

• Visual Analog Scale [Срок оценки: Before treatment, and at the 1st, 3rd, and 6th months following treatment]

Вторичные конечные точки (2)

• Paris Functional Coccydynia Questionnaire [Срок оценки: Before treatment and at the 1st, 3rd, and 6th months after treatment]
• Visual Analog Scale-Global Assesment [Срок оценки: before treatment, and at the 1st, 3rd, and 6th months following treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Reha — Istanbul

Идентификаторы

NCT: NCT07552298 · IstanbulU-2022-77979112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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