跳至主要内容
临床试验/NCT07094997
NCT07094997招募中不适用

Effectiveness of Massage Therapy Among Healthcare Workers Suffering From Low Back Pain - a Randomized Controlled Trial

Wroclaw University of Health and Sport Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
VAS scale

研究概览

简要总结

The piriformis muscle can be a contributing factor to low back pain (LBP) due to its anatomical proximity to the sciatic nerve and sacroiliac joint. When the piriformis becomes tight or irritated, it may compress or irritate the sciatic nerve-a condition often referred to as piriformis syndrome-leading to pain that radiates from the lower back to the buttock and down the leg.

The goal of this clinical trial is to examine the effectiveness of massage therapy in counteracting symptoms of low back pain (LBP) among healthcare workers. The main question it aims to answer is:

- Can massage of the piriformis muscle and related musculature effectively reduce symptoms in individuals experiencing LBP linked to myofascial or neuromuscular dysfunction?

Massage therapy targeting the piriformis and associated muscles (e.g., gluteus maximus, medius, and deep hip rotators) can help by:

  • Reducing muscle tension and spasms,
  • Improving local blood circulation,
  • Alleviating pressure on the sciatic nerve,
  • Restoring hip mobility and muscle balance.

详细描述

Background and Rationale Low back pain (LBP) is a prevalent musculoskeletal condition, particularly among healthcare workers due to occupational stress and physical demands. The piriformis muscle, located in the deep gluteal region, plays a crucial role in hip stabilization and external rotation. Due to its anatomical proximity to the sciatic nerve and sacroiliac joint, hypertonicity or irritation of the piriformis muscle may lead to compression of the sciatic nerve-a condition clinically recognized as piriformis syndrome-which manifests as radiating pain from the lower back through the buttock and into the posterior thigh and leg.

Myofascial and neuromuscular dysfunctions of the piriformis and surrounding musculature (including the gluteus maximus, gluteus medius, and deep lateral rotators) are increasingly implicated in chronic, nonspecific LBP. Massage therapy interventions targeting these soft tissue structures may reduce neuromuscular hyperactivity, restore muscular balance, and decrease nociceptive input. However, there is limited high-quality evidence evaluating the comparative effectiveness of professional massage therapy alone versus in combination with self-massage techniques for addressing piriformis-related LBP.

Additionally, there is no standardized approach based on guidelines developed by medical associations. There is a clear need to formulate and evaluate evidence-based protocols for the management of low back pain (LBP). This study will focus on implementing and assessing guidelines provided by the Polish Society of Physiotherapy, the Polish Society of Family Medicine, and European rural health organizations.

Techniques used during the intervention include targeted soft tissue mobilization focused on:

  • Piriformis
  • Gluteus maximus and medius
  • Obturator internus/externus
  • Quadratus femoris

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 (Participant)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult healthcare workers
  • •Aged 30-65 years with chronic nonspecific low back pain for ≥3 months
  • •No medical contraindications to massage therapy
  • •Body mass index (BMI) between 18.5 and 25 kg/m²
  • •Provided written informed consent

排除标准

  • •Massage therapy within the past 3 months
  • •Contraindications to massage therapy
  • •Ongoing physical therapy
  • •Significant medical or psychiatric conditions

研究组 & 干预措施

Guideline-Based Massage Therapy + Self-Massage Group (GMT+SM)

Experimental

GMT+SM - Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners. Delivered by licensed therapists.

Self-Massage Training:

One in-person instructional session, plus take-home materials (videos and printed instructions).

干预措施: Guidline-basaed massage therapy (Other)

Guideline-Based Massage Therapy (GMT)

Experimental

GMT - Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners. Delivered by licensed therapists.

干预措施: Guidline-basaed massage therapy (Other)

Control group (CG)

Active Comparator

Participants receive Swedish massage

干预措施: Swedish massage (Other)

结局指标

主要结局

VAS scale

时间窗: From enrollment to the end of treatment at 2 weeks

Visual Analogue Scale (VAS) is a continuous scale consisting of a horizontal line, 100 mm long, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). VAS is frequently used to determine the effectiveness of treatment as an outcome measure. Most studies show that VAS is a valid and reliable scale.

ODI

时间窗: From enrollment to the end of treatment at 2 weeks

The ODI (Oswestry Disability Index) is a standardized questionnaire used to measure a patient's level of disability due to lower back pain. It assesses how back pain affects a person's ability to manage everyday life.

次要结局

  • Thermography(From enrollment to the end of treatment at 2 weeks)
  • Doppler USG(From enrollment to the end of treatment at 2 weeks)

研究者

发起方
Wroclaw University of Health and Sport Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Krzysztof Kassolik, Phd

PhD

Wroclaw University of Health and Sport Sciences

研究点 (1)

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