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临床试验/NCT07694219
NCT07694219已完成不适用

Comparison of Bowen Therapy and McGill Stabilization Exercises on Pain, Range of Motion, and Disability in Chronic Low Back Pain: A Randomized Controlled Trial

Sehat Medical Complex1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

This randomized controlled trial aims to compare the effectiveness of Bowen Therapy combined with McGill stabilization exercises versus Bowen Therapy alone in individuals with chronic nonspecific low back pain. The study will evaluate changes in pain intensity, lumbar range of motion, and functional disability over a six-week intervention period. It is hypothesized that the combined intervention will produce greater improvements in clinical outcomes than Bowen Therapy alone.

详细描述

This is a single-center, parallel-group, randomized controlled trial conducted at Sehat Medical Complex. A total of 100 participants aged 25-55 years with chronic nonspecific low back pain of more than three months' duration will be randomly allocated to one of two treatment groups using a computer-generated randomization sequence.

Participants in the experimental group will receive Bowen Therapy combined with the McGill stabilization exercise program, while participants in the comparator group will receive Bowen Therapy alone. Both groups will receive standard physiotherapy modalities, including a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS) before each treatment session. The intervention period will last six weeks, with treatment sessions conducted three times per week.

Outcome assessments will be performed at baseline and at Weeks 2, 4, and 6. Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), lumbar range of motion will be assessed using a bubble inclinometer, and functional disability will be evaluated using the Modified Oswestry Disability Index (MODI). All assessments will be performed by the same trained physiotherapist to ensure measurement consistency.

The study has been approved by the Institutional Review Board of Sehat Medical Complex (Approval No. IREB-UOL-SMC/001-26/2024) and will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants before enrollment. Statistical analysis will be performed using SPSS version 25.0. Descriptive statistics will summarize baseline characteristics, the Shapiro-Wilk test will assess data normality, and repeated-measures analysis of variance (RM-ANOVA) will be used to evaluate changes between groups over time. Statistical significance will be set at p < 0.05.

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
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • With chronic localized low back pain lasting over three months
  • Without any signs of pain below the gluteal fold
  • Fulfills the recommended diagnostic criteria of nonspecific chronic low back pain.

排除标准

  • Lumbar disc herniation
  • Lumbar canal stenosis
  • Spondylolisthesis
  • Spondylitis
  • Radiculopathy
  • Vertebral fracture
  • Neurological deficits
  • Pregnancy or radiating pain below the gluteal fold.

研究组 & 干预措施

Bowen Therapy + McGill Stabilization Exercise

Experimental

Participants received a combined intervention consisting of Bowen Therapy and McGill stabilization exercises for six weeks. The McGill exercise program included curl-up, side-bridge, and bird-dog exercises performed three sessions per week on alternate days, with 30 repetitions and a 10-second isometric hold per repetition. Conventional physiotherapy exercises, including single and double knee-to-chest stretches, prone lying, heel slides, supine bicycling, and bridging exercises, were also provided. Before each treatment session, participants received a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS).

干预措施: Bowen Therapy + McGill Stabilization Exercise (Procedure)

Bowen Therapy Alone

Active Comparator

Participants received Bowen Therapy alone for six weeks. Bowen Therapy consisted of gentle rolling manual movements applied to muscles, tendons, ligaments, and fascia using the fingers or thumbs, with 2-5 minute intervals between movement sequences. Each session included two to three repetitions per set and four to five sets following a standardized treatment protocol. Participants also received standard physiotherapy modalities, including a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS) before each treatment session.

干预措施: Bowen Therapy (Procedure)

结局指标

主要结局

Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)

时间窗: Baseline, Week 2, Week 4, and Week 6

Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.

次要结局

  • Functional Disability Measured by the Modified Oswestry Disability Index (MODI)(Baseline, Week 2, Week 4, and Week 6)

研究者

发起方
Sehat Medical Complex
申办方类型
Other
责任方
Principal Investigator
主要研究者

Waseem Javaid

Assistant Professor

Sehat Medical Complex

研究点 (1)

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