Sacroiliac Joint DysfunctionNCT07550933
Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament in Patients With Sacroiliac Joint Dysfunctions
A study testing Group A: Dry Needling in people with Sacroiliac Joint Dysfunction, run by University of Social Welfare and Rehabilitation Science at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Group A: Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients with a previous history of fracture
- Prior SIJ surgery
- Osteoporosis
- Pregnancy or post-partum
- Lumbar disc herniation
- Carcinoma
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
CMH Medical College and IOD, Lahore, Pakistan
Lahore, Punjab Province, 54570
Dr. Fatima, +923414391882, aruj43@hotmail.com
About this study
Official title: Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament on Pain Intensity, Functional Disability, and Biomechanical Changes in Patients With Sacroiliac Joint Dysfunctions
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.
Read the 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.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Group A: Dry Needling, Group B: Sham Dry Needling
- Keywords
- Sacroiliac joint dysfunction, dry needling, physical therapy, sacrotuberous ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Dry NeedlingOther
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
Group B: Sham Dry NeedlingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 1. Group B: Sham Dry Needling | Experimental | Patients will receive sham dry needling plus routine physical therapy. Receives: Other: Group B: Sham Dry Needling |
| 2. Group A: Dry Needling | Experimental | Group A: Intervention Group: Patients will receive dry needling targeting the STL plus routine physical therapy. Receives: Other: Group A: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
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."
Measured: Six months
Body Mass Index
Height in cm, weight in kg
Measured: six months
Age
Age in years
Measured: six months
Secondary outcomes (3)
Biomechanical Changes
SIJ range of motion (inclinometer)
Measured: Six months
Oswestry Disability Index
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.
Measured: Six months
Biomechanical Changes
STL elasticity (ultrasound elastography)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, parallel-group, randomised controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syeda Arooj Fatima, University of Social Welfare and Rehabilitation Science
- Investigators
- Syeda Arooj Fatima, PhD, Principal investigator, University of Social Welfare and Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550933
- Sponsor's protocol ID
- UniversitySWRS
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34525901
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament on Pain Intensity, Functional Disability, and Biomechanical Changes in Patients With Sacroiliac Joint Dysfunctions
- ClinicalTrials.gov ID
- NCT07550933
- Acronym / sponsor ID
- UniversitySWRS
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- Sacroiliac joint dysfunction, dry needling, physical therapy, sacrotuberous ligament
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, parallel-group, randomised controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| 1. Group B: Sham Dry Needling | Experimental | Other: Group B: Sham Dry NeedlingPatients will receive sham dry needling plus routine physical therapy. |
| 2. Group A: Dry Needling | Experimental | Other: Group A: Dry NeedlingGroup A: Intervention Group: Patients will receive dry needling targeting the STL plus routine physical therapy. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (16 listed)
- Patients with a previous history of fracture
- Prior SIJ surgery
- Osteoporosis
- Pregnancy or post-partum
- Lumbar disc herniation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: Dry NeedlingIn 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 | Other | 2. Group A: Dry Needling |
| Group B: Sham Dry NeedlingIdentify 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). | Other | 1. Group B: Sham Dry Needling |
Primary outcome
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."
Body Mass Index
Time frame: six months
Height in cm, weight in kg
Age
Time frame: six months
Age in years
3 secondary outcomes
Biomechanical Changes
Time frame: Six months
Oswestry Disability Index
Time frame: Six months
Biomechanical Changes
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Results publication: PubMed 34525901Koppenhaver 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.
- Google ScholarLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syeda Arooj Fatima, PhD principal investigator
University of Social Welfare and Rehabilitation Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Dry Needling in people with Sacroiliac Joint Dysfunction, run by University of Social Welfare and Rehabilitation Science at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Fatima, PhD (+92 341 4391882, editor@thehealerjournal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07550933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.