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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Social Welfare and Rehabilitation Science

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Connective tissue dry needling

    Procedure/Surgery

    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.

  • Exercise therapy

    Procedure/Surgery

    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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Exercise therapyActive comparator 1 intervention
Group B: CTDN (Mahshid technique) plus Exercise therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
30 minutes
3

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.

Time frame
2 weeks
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.

Time frame
3-month follow-up

Secondary outcomes

1

Lumbar flexion range of motion

Lumbar flexion will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal flexion. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.

Time frame
Baseline
2

Lumbar flexion range of motion

Lumbar flexion will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal flexion. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.

Time frame
30 minutes
3

Lumbar flexion range of motion

Lumbar flexion will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal flexion. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.

Time frame
2 weeks
4

Lumbar extension range of motion

Lumbar extension will be measured using a digital inclinometer app (iHandy® Level, version 1.70.3, Apple Inc.) installed on an iPhone® 8 Plus device. The device will be placed on the L1 and S2 spinous processes while the participant performs maximal extension. The total range of motion will be calculated by subtracting the S2 angle from the L1 angle.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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