NCT07550933

Brief 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. 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 Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Apr 2026Nov 2026

Study Start

First participant enrolled

April 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 5, 2026

Last Update Submit

April 19, 2026

Conditions

Keywords

Sacroiliac joint dysfunctiondry needlingphysical therapysacrotuberous ligament

Outcome Measures

Primary Outcomes (3)

  • 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."

    Six months

  • Body Mass Index

    Height in cm, weight in kg

    six months

  • Age

    Age in years

    six months

Secondary Outcomes (3)

  • Biomechanical Changes

    Six months

  • Oswestry Disability Index

    Six months

  • Biomechanical Changes

    Six months

Study Arms (2)

1. Group B: Sham Dry Needling

EXPERIMENTAL

Patients will receive sham dry needling plus routine physical therapy.

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.

Other: Group A: Dry Needling

Interventions

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

2. Group A: 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; 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).

1. Group B: Sham Dry Needling

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Medical College and IOD, Lahore, Pakistan

Lahore, Punjab Province, 54570, Pakistan

Location

Related Publications (1)

  • 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.

    RESULT

Related Links

Study Officials

  • Syeda Arooj Fatima, PhD

    University of Social Welfare and Rehabilitation Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blinded, parallel-group, randomised controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., Professor, Post-Doc Fellow

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 24, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations