Меню
Набор скоро начнётся NCT07550933

Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament in Patients With Sacroiliac Joint Dysfunctions

Без фазы С лечением Sacroiliac Joint Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group A: Dry Needling, Group B: Sham Dry Needling.
Кому может быть актуально
Состояния в реестре: Sacroiliac Joint Dysfunction. Базовые параметры: 40 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament on Pain Intensity, Functional Disability, and Biomechanical Changes in Patients With Sacroiliac Joint Dysfunctions

Обзор

Sacroiliac joint dysfunction is a common source of low back and pelvic pain, often caused by improper load transfer through the pelvis. The sacrotuberous ligament stabilises the sacroiliac joint by limiting sacral nutation and supporting posterior pelvic structures. The sacroiliac joint connects the sacrum to the ischial tuberosity and integrates with muscles like the gluteus maximus and biceps femoris. Tightness, dysfunction, or pain in the sacrotuberous ligament can exacerbate sacroiliac joint dysfunction by altering mechanics. Dry needling is increasingly used for myofascial pain and muscle dysfunction. Applying dry needling to release ligamentous structures is novel and may improve the biomechanics of the sacroiliac joint by alleviating tension in the sacrotuberous ligament. The aim of the study is to investigate the efficacy of dry needling for releasing the sacrotuberous ligament in patients with sacroiliac joint dysfunctions on pain intensity, functional disability, and biomechanical changes, along with routine physical therapy compared to sham dry needling and routine physical therapy.

Подробное описание

Specific Objectives:

1. To assess the effects of STL dry needling on pain intensity in patients with sacroiliac joint dysfunction, as measured by the Numeric Pain Rating Scale. 2. To assess the impact of STL dry needling on functional disability in patients with sacroiliac joint dysfunction, as measured by the Oswestry Disability Index. 3. To examine biomechanical changes in sacroiliac joint mobility and sacrotuberous ligament elasticity using inclinometry and ultrasound elastography. 4. To compare the short-term (2-week) and longer-term (4-week) outcomes between the dry needling and sham dry needling groups.

Methodology:

Study Intervention/Experimental Manipulation:

Group A: Intervention Group: Patients will receive dry needling targeting the sacrotuberous ligament plus routine physical therapy.

Group B: Control Group: Patients will receive sham dry needling plus routine physical therapy.

Study Population:

Diagnosed patients having symptoms of sacroiliac joint dysfunction, both genders, aged between 40-65 years,1 standardised clinical tests positive (Fortin finger test, Patrick's test), and imaging (MRI/X-ray). In the current study, 80 participants have been selected, and after fulfilling the inclusion criteria, 60 have been recruited for the study, and then they will be randomly allocated to two groups.

Research Design:

This is a double-blinded, parallel-group, randomised controlled clinical trial.

Study setting:

It will be conducted at the Physiotherapy Department, Ghurki Hospital, Lahore, Pakistan.

Endpoints:

Primary Endpoint: 2nd week Secondary Endpoints: 4th week Estimated time: 6 months Pain intensity, functional disability, and biomechanical changes will be evaluated using the NPRS, ODI, and ultrasound elastography, respectively, at three follow-ups, i.e., baseline, end of the 2nd and 4th week. Both patient groups will undergo three treatment sessions per week for four weeks.

Population and Sampling Technique:

Non-probability convenience sampling will be used to select patients diagnosed with the symptoms of sacroiliac joint dysfunction.

Sample Size:

About 60 participants will be recruited for the trial.

Patients with diagnosed sacroiliac joint dysfunction will be included, while patients aged older and suffering from conditions such as a history of fracture, surgery, osteoporosis, pregnancy, lumbar disc herniation, carcinoma, or lumbar radiculopathy will be excluded from the study. Before participation, informed consent will be obtained from all patients. Data will be collected using a structured, self-administered questionnaire that will include sections on demographic details, knowledge, session ratings, and the perceived effects of the two treatment approaches. The patients will be randomly divided into two groups: Group A will receive dry needling targeting the sacrotuberous ligament along with routine physical therapy, while Group B will be given sham dry needling plus routine physical therapy. Data will be presented as means and standard deviations. Before conducting a statistical analysis, assumptions for each test will be verified. The mean pain ratings across all sessions will be analysed using repeated measures ANOVA, considering the treatment group as a factor. To assess the effectiveness of each treatment, paired-sample t-tests will compare pain ratings from the first session to the sixth session within each group. An independent sample t-test will be used to compare the mean pain ratings between the two groups across all sessions. The analysis will determine whether there are significant differences between the population means.

Вмешательства

  • Другое Group A: Dry Needling
    In Group A, Dry needling of the STL will be performed with the patient in a prone position, supported with a pillow under the abdomen to minimize lumbar lordosis. After antiseptic skin preparation and adherence to infection-control protocols, sterile, single-use filiform needles (0.25-0.30 mm gauge, 50-75 mm length depending on patient body habitus) will be applied. Anatomical landmarks, including the posterior superior iliac spine, sacrum (S3-S5), and ischial tuberosity, will be palpated to ide
  • Другое Group B: Sham Dry Needling
    Identify anatomical landmarks (PSIS, ischial tuberosity, S3-S5) and palpate the STL region exactly as in active DN. Place the introducer tube against the skin at the planned point(s); tap the top of the (blunt/retractable) needle as if inserting. For a fixed blunt-needle sham: insert the guide tube, then tap a blunt needle that is fixed inside the tube so it does not penetrate the skin (the subject feels pressure and tapping). For a retractable needle (Streitberger/Park): perform the same steps;

Первичные конечные точки

  • Numeric Pain Rating Scale [Срок оценки: Six months]
  • Body Mass Index [Срок оценки: six months]
  • Age [Срок оценки: six months]
Вторичные конечные точки (3)
  • Biomechanical Changes [Срок оценки: Six months]
  • Oswestry Disability Index [Срок оценки: Six months]
  • Biomechanical Changes [Срок оценки: Six months]

Критерии участия

Критерии включения

  • Diagnosed patients having symptoms of sacroiliac joint dysfunction
  • Both genders
  • Age 40-65 years
  • Standard clinical tests positive (Fortin finger test, Patrick's test)
  • Imaging (MRI/X-ray)

Критерии исключения

  • Patients with a previous history of fracture
  • Prior SIJ surgery
  • Osteoporosis
  • Pregnancy or post-partum
  • Lumbar disc herniation
  • Carcinoma
  • Dislocation in the lower back and lower extremity
  • Spinal stenosis that may cause pain in the lower back and hips
  • Piriformis syndrome
  • Lumbar radiculopathy
  • Existence of known osteoporosis
  • Metabolic diseases
  • Severe cardiovascular disease
  • Uncontrolled hypertension
  • Severe renal diseases
  • Bilateral cases

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

Пакистан · 1 центр
  • CMH Medical College and IOD, Lahore, Pakistan — Lahore

Публикации

  • Koppenhaver SL, Weaver AM, Randall TL, Hollins RJ, Young BA, Hebert JJ, Proulx L, Fernandez-de-Las-Penas C. Effect of dry needling on lumbar muscle stiffness in patients with low back pain: A double blind, randomized controlled trial using shear wave elastography. J Man Manip Ther. 2022 Jun;30(3):154-164. doi: 10.1080/10669817.2021.1977069. Epub 2021 Sep 16. PMID 34525901

Идентификаторы

NCT: NCT07550933 · UniversitySWRS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗