- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550933
Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament in Patients With Sacroiliac Joint Dysfunctions
Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament on Pain Intensity, Functional Disability, and Biomechanical Changes in Patients With Sacroiliac Joint Dysfunctions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific Objectives:
- 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.
- To assess the impact of STL dry needling on functional disability in patients with sacroiliac joint dysfunction, as measured by the Oswestry Disability Index.
- To examine biomechanical changes in sacroiliac joint mobility and sacrotuberous ligament elasticity using inclinometry and ultrasound elastography.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Fatima, PhD
- Phone Number: +92 341 4391882
- Email: editor@thehealerjournal.com
Study Contact Backup
- Name: Syeda Arooj Fatima, PhD
- Phone Number: +92 323 2274767
- Email: aroojfatimapt@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54570
- CMH Medical College and IOD, Lahore, Pakistan
-
Contact:
- Dr. Fatima
- Phone Number: +923414391882
- Email: aruj43@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1. Group B: Sham Dry Needling
Patients will receive sham dry needling plus routine physical therapy.
|
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).
|
|
Experimental: 2. Group A: Dry Needling
Group A: Intervention Group: Patients will receive dry needling targeting the STL plus routine physical therapy.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
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."
|
Six months
|
|
Body Mass Index
Time Frame: six months
|
Height in cm, weight in kg
|
six months
|
|
Age
Time Frame: six months
|
Age in years
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biomechanical Changes
Time Frame: Six months
|
SIJ range of motion (inclinometer)
|
Six months
|
|
Oswestry Disability Index
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.
|
Six months
|
|
Biomechanical Changes
Time Frame: Six months
|
STL elasticity (ultrasound elastography)
|
Six months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Syeda Arooj Fatima, PhD, University of Social Welfare and Rehabilitation Science
Publications and helpful links
General Publications
- Koppenhaver SL, Weaver AM, Randall TL, et al. Effect of dry needling on lumbar muscle stiffness in patients with low back pain: A double blind, randomized controlled trial using shear wave elastography. Journal of Manual & Manipulative Therapy 2022; 30(3): 154-64.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UniversitySWRS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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