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临床试验/NCT07181395
NCT07181395尚未招募不适用

Comparison of the Effectiveness of Two Different Mulligan Mobilization Techniques in Patients With Non-Specific Low Back Pain: A Triple-Blind Randomized Controlled Trial

Gazi University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Pain Intensity (Visual Analog Scale, VAS)

研究概览

简要总结

This study aims to compare the effectiveness of two different Mulligan mobilization techniques in patients with non-specific low back pain. A total of 30 adults with chronic low back pain will be randomly assigned to three groups: (1) conventional physiotherapy plus hip internal rotation Mulligan mobilization, (2) conventional physiotherapy plus straight leg raise Mulligan mobilization, or (3) conventional physiotherapy only. The interventions will be applied twice a week for four weeks. The main outcomes are pain intensity (measured by Visual Analog Scale) and lumbar range of motion. Secondary outcomes include disability level (Oswestry Disability Index) and back awareness (Fremantle Back Awareness Questionnaire). The study will help determine whether Mulligan techniques provide additional benefits beyond conventional physiotherapy in reducing pain and improving function in people with non-specific low back pain.

详细描述

Low back pain is the second most common cause of disability worldwide and significantly affects quality of life and healthcare systems. Non-specific low back pain (NSLBP) accounts for nearly 85% of all low back pain cases and is associated with loss of function, reduced productivity, and psychological problems. Physiotherapy approaches such as exercise, manual therapy, electrotherapy, and patient education are widely used, but not all patients benefit equally, highlighting the need for innovative and individualized treatment strategies. Mulligan mobilization is a manual therapy method that combines physiological joint movements with pain-free mobilization techniques. Techniques such as hip mobilization and traction-assisted straight leg raise (SLR) are thought to improve pain, range of motion, and functional outcomes. Although some studies suggest positive effects of Mulligan techniques, there is a lack of randomized controlled trials directly comparing different Mulligan approaches in patients with NSLBP. This triple-blind randomized controlled trial will investigate the comparative effectiveness of two Mulligan mobilization techniques. Thirty adults with NSLBP will be randomly assigned into three groups: (1) conventional physiotherapy plus hip internal rotation Mulligan mobilization, (2) conventional physiotherapy plus SLR Mulligan mobilization, and (3) conventional physiotherapy only. Interventions will be delivered twice a week for four weeks by experienced physiotherapists certified in the Mulligan Concept®. The primary outcomes will be pain intensity measured with the Visual Analog Scale (VAS) and lumbar range of motion assessed by goniometer. Secondary outcomes include disability level measured with the Oswestry Disability Index (ODI) and back awareness assessed with the Fremantle Back Awareness Questionnaire (FreBAQ). The findings of this study are expected to provide evidence on whether Mulligan mobilization techniques offer additional benefits beyond conventional physiotherapy in the management of non-specific low back pain.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

This is a triple-blind study. Participants, outcome assessors, and investigators performing data analysis are blinded to group allocation. Only physiotherapists delivering the interventions are not blinded.

入排标准

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

入选标准

  • Age ≥ 18 years
  • Diagnosed with non-specific low back pain (NSLBP) for at least 3 months
  • Able to walk independently
  • Willing to participate and provide written informed consent

排除标准

  • Specific causes of low back pain (e.g., disc herniation, spinal stenosis, tumor)
  • Presence of neurological deficits or radiculopathy
  • Hip joint pathologies limiting mobility (e.g., osteoarthritis)
  • History of lumbar surgery in the last 6 months
  • Diagnosed osteoporosis or osteopenia
  • Contraindications for Mulligan mobilization
  • Severe physical or cognitive impairments preventing participation
  • Participation in other physiotherapy or manual therapy treatments during the study period

结局指标

主要结局

Pain Intensity (Visual Analog Scale, VAS)

时间窗: Baseline (week 0) and post-treatment (week 4).

Pain intensity will be assessed using the Visual Analog Scale (VAS), a 100 mm horizontal line ranging from "no pain" to "worst pain imaginable." Participants will mark their pain level, and the distance in millimeters will be recorded.

Lumbar Range of Motion (ROM)

时间窗: Baseline (week 0) and post-treatment (week 4).

Lumbar spinal range of motion will be measured using a goniometer. Participants will perform active forward flexion, and the angle of motion will be recorded in degrees.

次要结局

  • Disability Level (Oswestry Disability Index - ODI)(Baseline (week 0) and post-treatment (week 4))
  • Back Awareness (Fremantle Back Awareness Questionnaire - FreBAQ)(Baseline (week 0) and post-treatment (week 4).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bulent ELBASAN

Professor Dr.

Gazi University

研究点 (1)

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