CMH Medical College and IOD, Lahore, Pakistan
Lahore, Punjab Province, 54570, Pakistan
NCT Number: NCT07550933
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.
Trial opening soon.
Get Notified40 year–65 year
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54570, Pakistan
Specific Objectives:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 identify the taut band of the ligament. Needle insertion will be carried out obliquely or slightly medially at a 30-45° angle, with a penetration depth of approximately 4-6 cm, adjusted according to individual anatomy and confirmed where possible by ultrasound guidance to enhance precision and safety. One to two needles will be inserted per symptomatic side, with bilateral treatment applied when indicated. Each needle will be retained for 30-60 seconds with light pistoning if required
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; the needle telescopes into handle on contact so skin is not pierced. Simulate identical manual manoeuvres (light pistoning or gentle manipulation of the introducer) for the same time as active DN (e.g., 30-60 sec). If the active protocol uses ultrasound guidance, simulate ultrasound probe contact and display but do not show images to the patient. Apply similar post-procedure care (pressure, dressing if used, reassurance).
Time frame: Six months
The numeric pain rating scale (NPRS) is a validated subjective measure for acute or chronic pain assessment. Scores are based on self-reported measures of symptoms that are recorded by making a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time frame: six months
Height in cm, weight in kg
Time frame: six months
Age in years
Time frame: Six months
SIJ range of motion (inclinometer)
Time frame: Six months
The Oswestry Disability Index (ODI) is a widely recognised and validated subjective tool for assessing functional disability in individuals with low back pain. This comprises 10 sections, each targeting a specific area of functional activity: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each section contains 6 statements, scored from 0 to 5, representing increasing levels of disability.
Time frame: Six months
STL elasticity (ultrasound elastography)
Contact information is provided by the study sponsor or research team.
Dr. Fatima, PhD
CONTACT
Syeda Arooj Fatima, PhD
CONTACT
University of Social Welfare and Rehabilitation Science
Other
Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament on Pain Intensity, Functional Disability, and Biomechanical Changes in Patients With Sacroiliac Joint Dysfunctions
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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