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Clinical Trials/NCT07550933
NCT07550933
Not yet recruiting
Not Applicable

Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament on Pain Intensity, Functional Disability, and Biomechanical Changes in Patients With Sacroiliac Joint Dysfunctions

University of Social Welfare and Rehabilitation Science1 site in 1 country60 target enrollmentStarted: April 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
University of Social Welfare and Rehabilitation Science
Enrollment
60
Locations
1
Primary Endpoint
Numeric Pain Rating Scale

Overview

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.

Detailed Description

Specific Objectives:

  1. 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.
  2. To assess the impact of STL dry needling on functional disability in patients with sacroiliac joint dysfunction, as measured by the Oswestry Disability Index.
  3. To examine biomechanical changes in sacroiliac joint mobility and sacrotuberous ligament elasticity using inclinometry and ultrasound elastography.
  4. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1. Group B: Sham Dry Needling

Experimental

Patients will receive sham dry needling plus routine physical therapy.

Intervention: Group B: Sham Dry Needling (Other)

2. Group A: Dry Needling

Experimental

Group A: Intervention Group: Patients will receive dry needling targeting the STL plus routine physical therapy.

Intervention: Group A: Dry Needling (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Biomechanical Changes(Six months)
  • Oswestry Disability Index(Six months)

Investigators

Sponsor
University of Social Welfare and Rehabilitation Science
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Syeda Arooj Fatima

Dr., Professor, Post-Doc Fellow

University of Social Welfare and Rehabilitation Science

Study Sites (1)

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