Connective Tissue Dry Needling for Low Back Pain Related to Local Posterior Superior Iliac Spine Pain

NCT07345871 | Not Yet Recruiting DMC

• 1 other identifier: USWR-3441
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Chronic Low Back Pain (CLBP); Sacroiliac Joint Dysfunction; Mechanical Low Back Pain

Keywords

Mechanical Low Back Pain; Sacroiliac Joint Dysfunction; Connective Tissue Disorders; Dry Needling; Fascia / Fascial Manipulation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  3-month follow-up

Secondary Outcomes (15)

• Lumbar flexion range of motion

  Baseline

• Lumbar flexion range of motion

  30 minutes

• Lumbar flexion range of motion

  2 weeks

• Lumbar extension range of motion

  Baseline

• Lumbar extension range of motion

  30 minutes

Study Arms (2)

Exercise therapy

ACTIVE COMPARATOR

Participants in this group will receive only the standardized exercise program over two weeks.

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.

Procedure: Connective tissue dry needling; Procedure: Exercise therapy

Interventions

Connective tissue dry needling PROCEDURE

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.

CTDN (Mahshid technique) plus Exercise therapy

Exercise therapy PROCEDURE

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.

CTDN (Mahshid technique) plus Exercise therapy; Exercise therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Social Welfare and Rehabilitation Science: lead

Related Publications (15)

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MeSH Terms

Conditions

Low Back Pain; Connective Tissue Diseases

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Mohammad Javaherian, Ph.D.

CONTACT

+989129321391; mohammadjavaherian1372@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01