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临床试验/NCT05021718
NCT05021718已完成不适用

Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in Patients With Lumbar Disc Herniation

Chittagong Medical College1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Changes in perceived pain intensity

研究概览

简要总结

Lumbar disc herniation (LDH) is one of the most common causes of mechanical low back pain (LBP) associated with radiating leg pain. Conservative treatment, including exercise, analgesic, and physical therapy, is regarded as the first-line treatment of LDH.

This randomized clinical trial was conducted to evaluate the effectiveness of back and hip strengthening exercises combined with activities of daily living instructions (ADLIs) to reduce pain intensity in patients with LDH.

详细描述

A total of 70 patients with LDH were randomly allocated to either the intervention group (IG) or the control group (CG). Patients in IG received different back and hip strengthening exercises five days a week for six weeks. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. In addition, the patients in both groups were instructed to follow the ADLIs during the intervention and at least 3 months after the intervention.

The straight leg raising (SLR) test and the Visual Analogue Scale (VAS) score were used to evaluate the patients' pain intensity. Outcomes were measured at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.

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
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 - 59 years.
  • Clinically diagnosed LDH that was confirmed by MRI.
  • Duration of the pain: ≥ 3 months

排除标准

  • Painful spinal deformity
  • Cauda equina syndrome
  • Progressive neurological signs and/or muscle-wasting
  • History of spinal surgery, spine fracture, scoliosis, tuberculosis, and tumours.
  • Treated with epidural injections.
  • Pregnancy

研究组 & 干预措施

Intervention group (IG)

Experimental

A total of 35 patients in IG received different back and hip strengthening exercises five times a week for six weeks. They were also instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.

干预措施: Strengthening exercises (Other)

Intervention group (IG)

Experimental

A total of 35 patients in IG received different back and hip strengthening exercises five times a week for six weeks. They were also instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.

干预措施: Activities to daily living instructions (Behavioral)

Control group (CG)

Active Comparator

The remaining 35 patients were allocated to CG. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. Moreover, they were instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.

干预措施: Pharmacological therapy (Drug)

Control group (CG)

Active Comparator

The remaining 35 patients were allocated to CG. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. Moreover, they were instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.

干预措施: Hot compression (Other)

Control group (CG)

Active Comparator

The remaining 35 patients were allocated to CG. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. Moreover, they were instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.

干预措施: Activities to daily living instructions (Behavioral)

结局指标

主要结局

Changes in perceived pain intensity

时间窗: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.

Visual analog scale (VAS) score: Patients were asked to rate their perceived pain on a 0-to-10-point scale, where 0 indicated no pain at all and 10 indicated the most severe imaginable pain.

次要结局

  • Changes in the range of hip flexion during straight leg raising test(Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.)

研究者

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

MD Imam Shahriar

FCPS student

Chittagong Medical College

研究点 (1)

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