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临床试验/NCT07345871
NCT07345871尚未招募不适用

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

University of Social Welfare and Rehabilitation Science0 个研究点目标入组 42 人开始时间: 2026年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
42
主要终点
Visual Analog Scale

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.
  • 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.

排除标准

  • 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

研究组 & 干预措施

Exercise therapy

Active Comparator

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

干预措施: Exercise therapy (Procedure)

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.

干预措施: Connective tissue dry needling (Procedure)

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.

干预措施: Exercise therapy (Procedure)

结局指标

主要结局

Visual Analog Scale

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • Lumbar extension range of motion(2 weeks)
  • Pressure Pain Threshold at the posterior superior iliac spine Region(Baseline)
  • Pressure Pain Threshold at the posterior superior iliac spine Region(30 minutes)
  • Pressure Pain Threshold at the posterior superior iliac spine Region(2 weeks)
  • Roland-Morris Disability Questionnaire(Baseline)
  • Roland-Morris Disability Questionnaire(30 minutes)
  • Roland-Morris Disability Questionnaire(2 weeks)
  • Short Form-36 Health Survey(Baseline)
  • Short Form-36 Health Survey(30 minutes)
  • Short Form-36 Health Survey(2 weeks)

研究者

发起方
University of Social Welfare and Rehabilitation Science
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Javaherian

Principal Investigator

University of Social Welfare and Rehabilitation Science

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