Efficacy of Dry Needling for Releasing the Sacrotuberous Ligament in Patients With Sacroiliac Joint Dysfunctions

University of Social Welfare and Rehabilitation Science

Status: Not yet enrolling

Conditions: Sacroiliac Joint Dysfunction

Treatments: Other: Group B: Sham Dry Needling; Other: Group A: Dry Needling

Study type: Interventional

Funder types: Other

Identifiers

NCT07550933

UniversitySWRS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

1. Group B: Sham Dry Needling

Experimental group

Description:

Patients will receive sham dry needling plus routine physical therapy.

Treatment:

Other: Group B: Sham Dry Needling

2. Group A: Dry Needling

Experimental group

Description:

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

Treatment:

Other: Group A: Dry Needling