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临床试验/NCT06699511
NCT06699511进行中(未招募)不适用

Effectiveness of Pilates in Patients With Subacute Low Back Pain

University of Beykent2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
66
试验地点
2
主要终点
Visual Analog Scale

研究概览

简要总结

This study aims to evaluate the effectiveness of Pilates exercises in patients with subacute low back pain, which typically lasts between 4 and 12 weeks. Subacute low back pain is longer-lasting than acute pain and can negatively impact daily activities and quality of life. Pilates is an exercise method that strengthens core muscle groups, improves flexibility, and supports body balance.

This research is designed as a comparative study between two groups. One group will participate in Pilates exercises, while the other group will follow a standard home exercise program. The study will assess outcomes such as pain level, mobility, and quality of life. Through this, the study aims to provide more insights into the potential of Pilates as a treatment method for subacute low back pain.

详细描述

This study investigates the role of Pilates exercises in managing subacute low back pain, a condition defined as lasting between 4 and 12 weeks. Subacute low back pain often disrupts daily functioning and lowers quality of life, and effective interventions during this stage are crucial to prevent the transition to chronic pain. Pilates has been suggested as a beneficial exercise approach due to its focus on core stability, flexibility, and balanced body mechanics, which may reduce pain and improve functional outcomes in low back pain patients.

Participants in the study will be divided into two groups: a Pilates group and a home exercise group. The Pilates group will participate in a structured Pilates program designed to target core muscle strength and flexibility over a set period, while the home exercise group will follow a standard exercise program tailored for general low back pain relief. Both groups will perform their respective exercises for eight weeks.

The primary outcome measures will include pain intensity, physical function, and quality of life, assessed at baseline, post-treatment, and follow-up periods. The findings from this study will contribute to understanding whether Pilates can be a valuable addition to conservative treatment approaches for subacute 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
Single (Participant)

盲法说明

In this clinical trial, masking will apply primarily to the Outcomes Assessor to ensure unbiased evaluation of results. The assessor, who will measure outcomes such as pain intensity, mobility, and quality of life, will be unaware of which intervention group (Pilates or home exercise) each participant belongs to. This masking minimizes the risk of bias in interpreting results based on prior knowledge of the intervention received by participants.

If there are additional parties involved in data analysis or reporting who might influence the results, they will also be masked to the intervention assignments to maintain the integrity of the study outcomes.

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

  • Adults aged between 18 and 65 years.D
  • Diagnosis of subacute low back pain, defined as pain lasting between 6 and 12 weeks
  • No previous Pilates experience.

排除标准

  • History of spinal surgery or significant spinal deformities (e.g., scoliosis).
  • Presence of serious medical conditions such as cardiovascular disease, uncontrolled hypertension, or neurological disorders.
  • Pregnancy or planned pregnancy during the study period.
  • Use of pain-relief medications that could interfere with the results of the study.
  • Participation in any structured physical therapy program in the last three months.

结局指标

主要结局

Visual Analog Scale

时间窗: pretreatment, post-treatment (8 weeks), and at 3-month follow-up

The Visual Analog Scale (VAS) is used to measure pain intensity. The scale ranges from 0 to 10, where 0 represents 'no pain' and 10 represents 'worst possible pain.' Higher scores indicate worse outcomes, signifying greater pain intensity

次要结局

未报告次要终点

研究者

发起方
University of Beykent
申办方类型
Other
责任方
Principal Investigator
主要研究者

TUĞBA ŞAHBAZ

Assoc. Prof

University of Beykent

研究点 (2)

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