Chronic Low Back Pain (CLBP)NCT07345871
Connective Tissue Dry Needling for Low Back Pain Related to Local Posterior Superior Iliac Spine Pain
A study testing Connective tissue dry needling and Exercise therapy in people with Chronic Low Back Pain (CLBP) and Sacroiliac Joint Dysfunction, run by University of Social Welfare and Rehabilitation Science.
Trial summary
This single-blind randomized controlled trial will aim to determine the effectiveness of a connective tissue dry needling (CTDN) technique, in reducing pain and improving function in individuals with chronic mechanical low back pain associated with pain and tenderness at the posterior superior iliac spine (PSIS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Sacroiliac Joint Dysfunction, Mechanical Low Back Pain
- What is being tested?
- Connective tissue dry needling and Exercise therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 1 Sep 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years.
- Diagnosed with chronic mechanical low back pain localized at the posterior superior iliac spine region.
- Presence of point tenderness reproducible by palpation at the posterior superior iliac spine area.
- Pain duration of at least two weeks, indicating the non-acute stage of low back pain.
- Negative results in at least three out of five sacroiliac pain provocation tests (Distraction, Compression, Thigh Thrust, Sacral Thrust, Gaenslen).
- Pain intensity ≥ 3 on the Numeric Rating Scale at baseline.
Show all 15Show fewer
- Ability to communicate and cooperate with the research team during intervention and follow-up.
- Access to WhatsApp or equivalent communication application for follow-up pain reporting at the 3-month stage.
- Non-inclusion criteria:
- Presence of lumbar radicular pain or referred pain to the lower limbs.
- History of lumbar spine trauma within the previous three months.
- Fear or intolerance of needling procedures.
- Current use of anticoagulant medication.
- Known lymphatic disorders, immunosuppressive diseases, or neurological conditions such as epilepsy or seizure disorders.
- Pregnancy or suspected pregnancy.
Who cannot join
- Voluntary withdrawal of consent at any time during the study.
- Inability to tolerate the intervention or adverse reaction during treatment sessions.
- Occurrence of serious adverse events or complications (e.g., infection, bleeding).
- Non-compliance with treatment protocol or missing more than two sessions.
- Any intercurrent illness or therapy that could interfere with the study outcomes or safety assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating the Effectiveness of Connective Tissue Dry Needling Technique on Patients With Low Back Pain Caused by Local Pain at Superior Posterior Iliac Spine: a Single-blind, Randomized Controlled Trial
This single-blind randomized controlled trial will aim to determine the effectiveness of a connective tissue dry needling (CTDN) technique, in reducing pain and improving function in individuals with chronic mechanical low back pain associated with pain and tenderness at the posterior superior iliac spine (PSIS). Forty participants with local PSIS-related low back pain will be recruited and randomly assigned into two groups using the block balanced randomization method. The treatment group will receive CTDN targeting connective tissue trigger points around the PSIS in addition to a sacroiliac joint stabilization exercise program, while the control group will perform the same exercise program alone under the supervision of a physiotherapist. The intervention protocol will span two weeks, during which participants will attend three treatment sessions per week, for a total of six sessions. The primary outcome measurement will use the Visual Analog Scale (VAS) to assess pain intensity. The study will measure secondary outcomes through lumbar range of motion (ROM) in flexion and extension and pressure pain threshold (PPT), and Roland-Morris Disability Questionnaire (RMDQ) functional disability and Short Form-36 (SF-36) health-related quality of life. The researchers will assess all outcomes at three time points: baseline and after the first session, and the sixth session, while VAS will receive an additional assessment at the 3-month follow-up. The findings of this study are expected to provide evidence supporting CTDN as a safe, effective, and cost-efficient treatment option for PSIS-related mechanical low back pain.
Read the detailed description
Low back pain (LBP) is one of the most widespread musculoskeletal disorders, which creates substantial disability and healthcare expenses throughout both developed and developing nations (1,2). The medical field categorizes LBP into two distinct types: specific and non-specific. The medical field identifies specific LBP through detectable causes, including infections and trauma and structural problems but non-specific LBP lacks identifiable spinal pathology and represents most cases (3,4). Research shows that LBP originates from multiple sources including intervertebral discs and facet joints and sacroiliac joints (SIJ) and their associated ligaments and muscles (5-8).
Research indicates that the SIJ acts as a primary pain source for 15-25% of patients who experience chronic LBP (9). The SIJ plays a vital biomechanical role by connecting the spine to the lower extremities through its complex network of ligaments and fascia which distributes both axial and rotational forces (10). The Posterior Superior Iliac Spine (PSIS) represents a significant anatomical reference point near the SIJ where multiple essential soft tissue structures including the long posterior sacroiliac ligament and thoracolumbar fascia and gluteus maximus converge (10,11). Studies based on clinical and anatomical evidence show that tissue dysfunction or irritation in this area leads to pain development in the PSIS region (12).
The Fascial Distortion Model (FDM) among other recent models demonstrates how fascia-bone junctions produce musculoskeletal pain through their mechanical interactions. The model indicates that extended periods of inactivity together with abnormal mechanical forces disrupt cellular communication and mineral transport at these junctions which leads to fascial adhesions and persistent pain (13,14). The complex anatomy and high sensitivity of the PSIS area has led to increased research about treatments that focus on the surrounding connective tissue structures.
The minimally invasive technique of dry needling fascial structures known as fascia dry needling (FDN) aims to create mechanical and cellular changes in the extracellular matrix of connective tissues. Research shows that dry needling procedures in connective tissue areas lead to increased fibroblast activity and cytoskeletal rearrangement which may create better matrix organization and decrease pain signals (15,17-19). Research through imaging and mechanobiological studies has proven that needle rotation in both directions leads to substantial tissue movement and increased gene expression for tissue repair without inflicting any structural harm (20-25).
Research conducted with animal subjects has validated these mechanistic results through observations of tendon recovery and tissue reorganization following needling procedures (22-25). The clinical application of dry needling has produced beneficial results for patients with lateral epicondylosis and Achilles tendinopathy and thoracic pain syndromes by improving their pain levels and mobility and functional abilities (26,29,30).
The medical field lacks any randomized controlled trial that investigates how fascia dry needling affects the PSIS region despite rising evidence about dry needling effects on different musculoskeletal conditions. The current clinical guidelines recommend periarticular or intra-articular injections for PSIS or SIJ-related pain but these procedures come with high costs and complex procedures and potential adverse effects for patients (31). The non-invasive nature of FDN makes it an attractive treatment option which needs thorough clinical assessment.
The research study aims to evaluate PSIS area fascia dry needling as an additional treatment for standard physiotherapy represents a critical knowledge gap in current medical literature. The confirmation of safety and effectiveness of this treatment method would lead to updated clinical guidelines and help decrease reliance on invasive procedures while giving healthcare providers an effective new treatment option for patients with PSIS-related mechanical low back pain.
Hypotheses:
Null Hypothesis (H₀): The fascia dry needling technique (Mahshid method) has no significant effect on pain intensity, lumbar range of motion, pain pressure threshold, functional disability, or quality of life in patients with chronic mechanical low back pain and point tenderness at the posterior superior iliac spine.
Alternative Hypothesis (H₁): The fascia dry needling technique (Mahshid method) has a significant positive effect on pain intensity, lumbar range of motion, pain pressure threshold, functional disability, and quality of life in patients with chronic mechanical low back pain and point tenderness at the posterior superior iliac spine.
- Being tested
- Connective tissue dry needling, Exercise therapy
- Keywords
- Mechanical Low Back Pain, Sacroiliac Joint Dysfunction, Connective Tissue Disorders, Dry Needling, Fascia / Fascial Manipulation
- Medical subject headings
- Low Back Pain, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue dry needlingProcedure or surgery
Connective tissue dry needling: Eight sterile single-use needles placed 1.5 cm from the PSIS center, inserted at about 45° to bony contact, withdrawn 0.5 cm, rotated five times to maximal tissue stiffness, then retained for 20 minutes with concurrent infrared therapy. Three sessions per week for two weeks, total six sessions. Needle size 50 mm × 0.5 mm.
Exercise therapyProcedure or surgery
Pelvic bridging, leg-lowering, curl-up or bridging, and isolated lumbar stabilizer training. Three sets of ten repetitions for each exercise, three sessions per week for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise therapy | Active comparator | Participants in this group will receive only the standardized exercise program over two weeks. Receives: Procedure: Exercise therapy |
| CTDN (Mahshid technique) plus Exercise therapy | Experimental | Participants in this group will receive CTDN targeting the PSIS region together with the standardized exercise program over two weeks. Receives: Procedure: Connective tissue dry needling; Procedure: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest value, representing the most severe pain.
Measured: Baseline
Visual Analog Scale
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest value, representing the most severe pain.
Measured: 30 minutes
Visual Analog Scale
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest value, representing the most severe pain.
Measured: 2 weeks
Visual Analog Scale
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest value, representing the most severe pain.
Measured: 3-month follow-up
Secondary outcomes (15)
Lumbar flexion range of motion
Lumbar flexion will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal flexion. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.
Measured: Baseline
Lumbar flexion range of motion
Lumbar flexion will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal flexion. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.
Measured: 30 minutes
Lumbar flexion range of motion
Lumbar flexion will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal flexion. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.
Measured: 2 weeks
Lumbar extension range of motion
Lumbar extension will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal extension. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.
Measured: Baseline
Lumbar extension range of motion
Lumbar extension will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal extension. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.
Measured: 30 minutes
Lumbar extension range of motion
Lumbar extension will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal extension. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.
Measured: 2 weeks
Pressure Pain Threshold at the posterior superior iliac spine Region
Pressure Pain Threshold will be measured using a mechanical pressure algometer (Lutron FG-5020, Taiwan). Pressure will be applied vertically over the posterior superior iliac spine region at a rate of approximately 1 kg/s until the participant first reports pain. The value will be recorded in kg/cm². Higher scores indicate greater tolerance and lower tissue tenderness.
Measured: Baseline
Pressure Pain Threshold at the posterior superior iliac spine Region
Pressure Pain Threshold will be measured using a mechanical pressure algometer (Lutron FG-5020, Taiwan). Pressure will be applied vertically over the posterior superior iliac spine region at a rate of approximately 1 kg/s until the participant first reports pain. The value will be recorded in kg/cm². Higher scores indicate greater tolerance and lower tissue tenderness.
Measured: 30 minutes
Pressure Pain Threshold at the posterior superior iliac spine Region
Pressure Pain Threshold will be measured using a mechanical pressure algometer (Lutron FG-5020, Taiwan). Pressure will be applied vertically over the posterior superior iliac spine region at a rate of approximately 1 kg/s until the participant first reports pain. The value will be recorded in kg/cm². Higher scores indicate greater tolerance and lower tissue tenderness.
Measured: 2 weeks
Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is a 24-item validated self-reported questionnaire assessing the impact of low back pain on daily life. Each "Yes" response scores 1 point, while "No" scores 0, yielding a total between 0 and 24. Higher scores indicate greater disability.
Measured: Baseline
Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is a 24-item validated self-reported questionnaire assessing the impact of low back pain on daily life. Each "Yes" response scores 1 point, while "No" scores 0, yielding a total between 0 and 24. Higher scores indicate greater disability.
Measured: 30 minutes
Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is a 24-item validated self-reported questionnaire assessing the impact of low back pain on daily life. Each "Yes" response scores 1 point, while "No" scores 0, yielding a total between 0 and 24. Higher scores indicate greater disability.
Measured: 2 weeks
Short Form-36 Health Survey
The validated Persian version of SF-36 will be used to assess eight domains of health-related quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health). Scores range from 0 (worst) to 100 (best).
Measured: Baseline
Short Form-36 Health Survey
The validated Persian version of SF-36 will be used to assess eight domains of health-related quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health). Scores range from 0 (worst) to 100 (best).
Measured: 30 minutes
Short Form-36 Health Survey
The validated Persian version of SF-36 will be used to assess eight domains of health-related quality of life (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health). Scores range from 0 (worst) to 100 (best).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start10 Apr 2026 (estimated)
- Primary completion14 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Javaherian, University of Social Welfare and Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345871
- Sponsor's protocol ID
- USWR-3441
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not decided yet, but at this moment, we have decided to share brief data with future researchers after requesting and submitting ethical committee permission.
Publications
Langevin HM, Churchill DL, Fox JR, Badger GJ, Garra BS, Krag MH. Biomechanical response to acupuncture needling in humans. J Appl Physiol (1985). 2001 Dec;91(6):2471-8. doi: 10.1152/jappl.2001.91.6.2471.
PubMed 11717207Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
PubMed 29573870Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1.
PubMed 30546064Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
PubMed 27745712Manchikanti L, Singh V, Pampati V, Damron KS, Beyer CD, Barnhill RC. Is there correlation of facet joint pain in lumbar and cervical spine? An evaluation of prevalence in combined chronic low back and neck pain. Pain Physician. 2002 Oct;5(4):365-71.
PubMed 16886014Yang H, Liu H, Li Z, Zhang K, Wang J, Wang H, Zheng Z. Low back pain associated with lumbar disc herniation: role of moderately degenerative disc and annulus fibrous tears. Int J Clin Exp Med. 2015 Feb 15;8(2):1634-44. eCollection 2015.
PubMed 25932092Vaccaro AR, Ring D, Scuderi G, Cohen DS, Garfin SR. Predictors of outcome in patients with chronic back pain and low-grade spondylolisthesis. Spine (Phila Pa 1976). 1997 Sep 1;22(17):2030-4; discussion 2035. doi: 10.1097/00007632-199709010-00018.
PubMed 9306535Werner CM, Hoch A, Gautier L, Konig MA, Simmen HP, Osterhoff G. Distraction test of the posterior superior iliac spine (PSIS) in the diagnosis of sacroiliac joint arthropathy. BMC Surg. 2013 Oct 31;13:52. doi: 10.1186/1471-2482-13-52.
PubMed 24175954Cohen SP. Sacroiliac joint pain: a comprehensive review of anatomy, diagnosis, and treatment. Anesth Analg. 2005 Nov;101(5):1440-1453. doi: 10.1213/01.ANE.0000180831.60169.EA.
PubMed 16244008Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.
PubMed 32123652Barker PJ, Hapuarachchi KS, Ross JA, Sambaiew E, Ranger TA, Briggs CA. Anatomy and biomechanics of gluteus maximus and the thoracolumbar fascia at the sacroiliac joint. Clin Anat. 2014 Mar;27(2):234-40. doi: 10.1002/ca.22233. Epub 2013 Aug 20.
PubMed 23959791Murakami E, Kurosawa D, Aizawa T. Treatment strategy for sacroiliac joint-related pain at or around the posterior superior iliac spine. Clin Neurol Neurosurg. 2018 Feb;165:43-46. doi: 10.1016/j.clineuro.2017.12.017. Epub 2017 Dec 21.
PubMed 29306764Langevin HM, Churchill DL, Wu J, Badger GJ, Yandow JA, Fox JR, Krag MH. Evidence of connective tissue involvement in acupuncture. FASEB J. 2002 Jun;16(8):872-4. doi: 10.1096/fj.01-0925fje. Epub 2002 Apr 10.
PubMed 11967233Langevin HM, Bouffard NA, Badger GJ, Churchill DL, Howe AK. Subcutaneous tissue fibroblast cytoskeletal remodeling induced by acupuncture: evidence for a mechanotransduction-based mechanism. J Cell Physiol. 2006 Jun;207(3):767-74. doi: 10.1002/jcp.20623.
PubMed 16511830Langevin HM, Yandow JA. Relationship of acupuncture points and meridians to connective tissue planes. Anat Rec. 2002 Dec 15;269(6):257-65. doi: 10.1002/ar.10185.
PubMed 12467083
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Connective Tissue Dry Needling Technique on Patients With Low Back Pain Caused by Local Pain at Superior Posterior Iliac Spine: a Single-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07345871
- Acronym / sponsor ID
- USWR-3441
- Keywords
- Mechanical Low Back Pain, Sacroiliac Joint Dysfunction, Connective Tissue Disorders, Dry Needling, Fascia / Fascial Manipulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 Jan 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.
This single-blind randomized controlled trial will aim to determine the effectiveness of a connective tissue dry needling (CTDN) technique, in reducing pain and improving function in individuals with chronic mechanical low back pain associated with pain and tenderness at the posterior superior iliac spine (PSIS). Forty participants with local PSIS-related low back pain will be recruited and randomly assigned into two groups using the block balanced randomization method. The treatment group will receive CTDN targeting connective tissue trigger points around the PSIS in addition to a sacroiliac joint stabilization exercise program, while the control group will perform the same exercise program alone under the supervision of a physiotherapist. The intervention protocol will span two weeks, during which participants will attend three treatment sessions per week, for a total of six sessions. The primary outcome measurement will use the Visual Analog Scale (VAS) to assess pain intensity. The study will measure secondary outcomes through lumbar range of motion (ROM) in flexion and extension and pressure pain threshold (PPT), and Roland-Morris Disability Questionnaire (RMDQ) functional disability and Short Form-36 (SF-36) health-related quality of life. The researchers will assess all outcomes at three time points: baseline and after the first session, and the sixth session, while VAS will receive an additional assessment at the 3-month follow-up. The findings of this study are expected to provide evidence supporting CTDN as a safe, effective, and cost-efficient treatment option for PSIS-related mechanical low back pain.
Detailed description
Low back pain (LBP) is one of the most widespread musculoskeletal disorders, which creates substantial disability and healthcare expenses throughout both developed and developing nations (1,2). The medical field categorizes LBP into two distinct types: specific and non-specific. The medical field identifies specific LBP through detectable causes, including infections and trauma and structural problems but non-specific LBP lacks identifiable spinal pathology and represents most cases (3,4). Research shows that LBP originates from multiple sources including intervertebral discs and facet joints and sacroiliac joints (SIJ) and their associated ligaments and muscles (5-8).
Research indicates that the SIJ acts as a primary pain source for 15-25% of patients who experience chronic LBP (9). The SIJ plays a vital biomechanical role by connecting the spine to the lower extremities through its complex network of ligaments and fascia which distributes both axial and rotational forces (10). The Posterior Superior Iliac Spine (PSIS) represents a significant anatomical reference point near the SIJ where multiple essential soft tissue structures including the long posterior sacroiliac ligament and thoracolumbar fascia and gluteus maximus converge (10,11). Studies based on clinical and anatomical evidence show that tissue dysfunction or irritation in this area leads to pain development in the PSIS region (12).
The Fascial Distortion Model (FDM) among other recent models demonstrates how fascia-bone junctions produce musculoskeletal pain through their mechanical interactions. The model indicates that extended periods of inactivity together with abnormal mechanical forces disrupt cellular communication and mineral transport at these junctions which leads to fascial adhesions and persistent pain (13,14). The complex anatomy and high sensitivity of the PSIS area has led to increased research about treatments that focus on the surrounding connective tissue structures.
The minimally invasive technique of dry needling fascial structures known as fascia dry needling (FDN) aims to create mechanical and cellular changes in the extracellular matrix of connective tissues. Research shows that dry needling procedures in connective tissue areas lead to increased fibroblast activity and cytoskeletal rearrangement which may create better matrix organization and decrease pain signals (15,17-19). Research through imaging and mechanobiological studies has proven that needle rotation in both directions leads to substantial tissue movement and increased gene expression for tissue repair without inflicting any structural harm (20-25).
Research conducted with animal subjects has validated these mechanistic results through observations of tendon recovery and tissue reorganization following needling procedures (22-25). The clinical application of dry needling has produced beneficial results for patients with lateral epicondylosis and Achilles tendinopathy and thoracic pain syndromes by improving their pain levels and mobility and functional abilities (26,29,30).
The medical field lacks any randomized controlled trial that investigates how fascia dry needling affects the PSIS region despite rising evidence about dry needling effects on different musculoskeletal conditions. The current clinical guidelines recommend periarticular or intra-articular injections for PSIS or SIJ-related pain but these procedures come with high costs and complex procedures and potential adverse effects for patients (31). The non-invasive nature of FDN makes it an attractive treatment option which needs thorough clinical assessment.
The research study aims to evaluate PSIS area fascia dry needling as an additional treatment for standard physiotherapy represents a critical knowledge gap in current medical literature. The confirmation of safety and effectiveness of this treatment method would lead to updated clinical guidelines and help decrease reliance on invasive procedures while giving healthcare providers an effective new treatment option for patients with PSIS-related mechanical low back pain.
Hypotheses:
Null Hypothesis (H₀): The fascia dry needling technique (Mahshid method) has no significant effect on pain intensity, lumbar range of motion, pain pressure threshold, functional disability, or quality of life in patients with chronic mechanical low back pain and point tenderness at the posterior superior iliac spine.
Alternative Hypothesis (H₁): The fascia dry needling technique (Mahshid method) has a significant positive effect on pain intensity, lumbar range of motion, pain pressure threshold, functional disability, and quality of life in patients with chronic mechanical low back pain and point tenderness at the posterior superior iliac spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy | Active comparator | Procedure: Exercise therapyParticipants in this group will receive only the standardized exercise program over two weeks. |
| CTDN (Mahshid technique) plus Exercise therapy | Experimental | Procedure: Connective tissue dry needling, Procedure: Exercise therapyParticipants in this group will receive CTDN targeting the PSIS region together with the standardized exercise program over two weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adults aged 18 to 75 years.
- Diagnosed with chronic mechanical low back pain localized at the posterior superior iliac spine region.
- Presence of point tenderness reproducible by palpation at the posterior superior iliac spine area.
- Pain duration of at least two weeks, indicating the non-acute stage of low back pain.
- Negative results in at least three out of five sacroiliac pain provocation tests (Distraction, Compression, Thigh Thrust, Sacral Thrust, Gaenslen).
Key exclusion criteria (5 listed)
- Voluntary withdrawal of consent at any time during the study.
- Inability to tolerate the intervention or adverse reaction during treatment sessions.
- Occurrence of serious adverse events or complications (e.g., infection, bleeding).
- Non-compliance with treatment protocol or missing more than two sessions.
- Any intercurrent illness or therapy that could interfere with the study outcomes or safety assessment
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 |
|---|---|---|
| Connective tissue dry needlingConnective tissue dry needling: Eight sterile single-use needles placed 1.5 cm from the PSIS center, inserted at about 45° to bony contact, withdrawn 0.5 cm, rotated five times to maximal tissue stiffness, then retained for 20 minutes with concurrent infrared therapy. Three sessions per week for two weeks, total six sessions. Needle size 50 mm × 0.5 mm. | Procedure or surgery | CTDN (Mahshid technique) plus Exercise therapy |
| Exercise therapyPelvic bridging, leg-lowering, curl-up or bridging, and isolated lumbar stabilizer training. Three sets of ten repetitions for each exercise, three sessions per week for two weeks. | Procedure or surgery | CTDN (Mahshid technique) plus Exercise therapy, Exercise therapy |
Primary outcome
Visual Analog Scale
Time frame: Baseline
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest value, representing the most severe pain.
Visual Analog Scale
Time frame: 30 minutes
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest value, representing the most severe pain.
Visual Analog Scale
Time frame: 2 weeks
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest value, representing the most severe pain.
Visual Analog Scale
Time frame: 3-month follow-up
It is a commonly used tool for measuring pain. The patient is asked to mark their pain level on a 100-mm line, and the marked distance is then measured with a ruler from the left end and recorded. The scale typically ranges from zero, indicating no pain, to the highest value, representing the most severe pain.
15 secondary outcomes
Lumbar flexion range of motion
Time frame: Baseline
Lumbar flexion range of motion
Time frame: 30 minutes
Lumbar flexion range of motion
Time frame: 2 weeks
Lumbar extension range of motion
Time frame: Baseline
Lumbar extension range of motion
Time frame: 30 minutes
Lumbar extension range of motion
Time frame: 2 weeks
Pressure Pain Threshold at the posterior superior iliac spine Region
Time frame: Baseline
Pressure Pain Threshold at the posterior superior iliac spine Region
Time frame: 30 minutes
Pressure Pain Threshold at the posterior superior iliac spine Region
Time frame: 2 weeks
Roland-Morris Disability Questionnaire
Time frame: Baseline
Roland-Morris Disability Questionnaire
Time frame: 30 minutes
Roland-Morris Disability Questionnaire
Time frame: 2 weeks
Short Form-36 Health Survey
Time frame: Baseline
Short Form-36 Health Survey
Time frame: 30 minutes
Short Form-36 Health Survey
Time frame: 2 weeks
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 21 Jan 2026.
- Results publication: PubMed 11717207Langevin HM, Churchill DL, Fox JR, Badger GJ, Garra BS, Krag MH. Biomechanical response to acupuncture needling in humans. J Appl Physiol (1985). 2001 Dec;91(6):2471-8. doi: 10.1152/jappl.2001.91.6.2471.
- Results publication: PubMed 29573870Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
- Results publication: PubMed 30546064Vlaeyen JWS, Maher CG, Wiech K, Van Zundert J, Meloto CB, Diatchenko L, Battie MC, Goossens M, Koes B, Linton SJ. Low back pain. Nat Rev Dis Primers. 2018 Dec 13;4(1):52. doi: 10.1038/s41572-018-0052-1.
- Results publication: PubMed 27745712Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
- Results publication: PubMed 16886014Manchikanti L, Singh V, Pampati V, Damron KS, Beyer CD, Barnhill RC. Is there correlation of facet joint pain in lumbar and cervical spine? An evaluation of prevalence in combined chronic low back and neck pain. Pain Physician. 2002 Oct;5(4):365-71.
- Results publication: PubMed 25932092Yang H, Liu H, Li Z, Zhang K, Wang J, Wang H, Zheng Z. Low back pain associated with lumbar disc herniation: role of moderately degenerative disc and annulus fibrous tears. Int J Clin Exp Med. 2015 Feb 15;8(2):1634-44. eCollection 2015.
- Results publication: PubMed 9306535Vaccaro AR, Ring D, Scuderi G, Cohen DS, Garfin SR. Predictors of outcome in patients with chronic back pain and low-grade spondylolisthesis. Spine (Phila Pa 1976). 1997 Sep 1;22(17):2030-4; discussion 2035. doi: 10.1097/00007632-199709010-00018.
- Results publication: PubMed 24175954Werner CM, Hoch A, Gautier L, Konig MA, Simmen HP, Osterhoff G. Distraction test of the posterior superior iliac spine (PSIS) in the diagnosis of sacroiliac joint arthropathy. BMC Surg. 2013 Oct 31;13:52. doi: 10.1186/1471-2482-13-52.
- Results publication: PubMed 16244008Cohen SP. Sacroiliac joint pain: a comprehensive review of anatomy, diagnosis, and treatment. Anesth Analg. 2005 Nov;101(5):1440-1453. doi: 10.1213/01.ANE.0000180831.60169.EA.
- Results publication: PubMed 32123652Kiapour A, Joukar A, Elgafy H, Erbulut DU, Agarwal AK, Goel VK. Biomechanics of the Sacroiliac Joint: Anatomy, Function, Biomechanics, Sexual Dimorphism, and Causes of Pain. Int J Spine Surg. 2020 Feb 10;14(Suppl 1):3-13. doi: 10.14444/6077. eCollection 2020 Feb.
- Results publication: PubMed 23959791Barker PJ, Hapuarachchi KS, Ross JA, Sambaiew E, Ranger TA, Briggs CA. Anatomy and biomechanics of gluteus maximus and the thoracolumbar fascia at the sacroiliac joint. Clin Anat. 2014 Mar;27(2):234-40. doi: 10.1002/ca.22233. Epub 2013 Aug 20.
- Results publication: PubMed 29306764Murakami E, Kurosawa D, Aizawa T. Treatment strategy for sacroiliac joint-related pain at or around the posterior superior iliac spine. Clin Neurol Neurosurg. 2018 Feb;165:43-46. doi: 10.1016/j.clineuro.2017.12.017. Epub 2017 Dec 21.
- Individual participant dataSharing planned: Undecided. We have not decided yet, but at this moment, we have decided to share brief data with future researchers after requesting and submitting ethical committee permission.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue dry needling and Exercise therapy in people with Chronic Low Back Pain (CLBP) and Sacroiliac Joint Dysfunction, run by University of Social Welfare and Rehabilitation Science.
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 15 inclusion and 5 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mohammad Javaherian, Ph.D. (+989129321391, mohammadjavaherian1372@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline). The study lists 4 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 NCT07345871, which also lists 15 linked publications.
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 21 Jan 2026.