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临床试验/NCT07382232
NCT07382232已完成不适用

An RCT of Isometric Stability Versus Isotonic Mobility for LBP Rehabilitation

Palestine Ahliya University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1日最近更新:
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
60
试验地点
1
主要终点
VAS

研究概览

简要总结

Background: Low back pain (LBP) is a leading cause of disability, often requiring primary care management.

Objective: To compare the effectiveness of isometric versus isotonic exercise programs for LBP.

Methods: Sixty adults with LBP were randomly assigned to two groups. Group A (n=30) performed isometric exercises, infrared therapy, and TENS. Group B (n=30) performed isotonic exercises with the same adjunct therapies. Pain (VAS), disability (MODI), and abdominal endurance were measured pre- and post-intervention.

Keywords: Exercise therapy; low back pain; disability evaluation

详细描述

Group-Specific Exercise Protocols:

  • Isometric Exercise Group (IEG): This group performed a circuit of three core-stabilizing isometric exercises, each held for 10 seconds with brief rest intervals, for 5 complete repetitions. The exercises included: (a) Isometric Curl-Up, (b) Side Bridge, and (c) Bird Dog. The total dedicated exercise time was approximately 20 minutes per session.
  • Isotonic Exercise Group (ITG): This group performed a circuit of three dynamic, strength-oriented isotonic exercises, each completed for 10 repetitions. The exercises included: (a) Bent Knee Sit-Up, (b) Cross Curl-Up, and (c) Prone Back Extension. The total dedicated exercise time was also approximately 20 minutes per session. All exercises were selected and adapted from previously published rehabilitation protocols for CLBP [13].

Adjunctive Therapies (Common to Both Groups):

  1. Infrared (IR) Therapy: A standard therapeutic infrared lamp was positioned 50 cm from the participant's lumbar spine at a 90-degree angle. Heat was applied for 15 minutes per session to promote muscle relaxation and local blood flow.
  2. Transcutaneous Electrical Nerve Stimulation (TENS): Electrodes were placed over the painful lumbar area. A low-frequency (<10 Hz) TENS unit was applied for 20 minutes per session. The analgesic mechanism of TENS is well-documented, involving the modulation of pain pathways via opioid and noradrenergic receptors in the central nervous system [16].

Both groups received a standardized four-week intervention program, consisting of three supervised sessions per week, totaling 12 sessions. Each 55-minute session included adjunctive therapies common to both groups, followed by the specific exercise protocol.

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 (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 60 years;
  • Diagnosis of non-specific CLBP, defined as pain localized between the lower rib margin and the gluteal folds persisting for more than three months;
  • Self-reported pain intensity score between 40 mm and 80 mm on a 100-mm Visual Analogue Scale (VAS), indicating moderate to severe pain;
  • Pain experienced on at least three days in the month preceding enrollment, with documented interference in daily activities;
  • A formal referral for physiotherapy management.

排除标准

  • The presence of "red flag" pathologies (e.g., spinal tumor, infection, fracture); - Neurological signs or symptoms suggestive of radiculopathy or myelopathy;
  • a history of spinal surgery or epidural steroid injections within the previous 12 months;
  • Systemic inflammatory diseases (e.g., rheumatoid arthritis) or major neurological disorders;
  • Pregnancy;
  • Receipt of physiotherapy for low back pain within the last six months;
  • Current use of non-steroidal anti-inflammatory drugs (NSAIDs) or inability to refrain from their use during the study period;
  • Any diagnosed psychiatric condition.

研究组 & 干预措施

arm 1- Group A : Isometric Exercises

Experimental

• Isometric Exercise Group (IEG): This group performed a circuit of three core-stabilizing isometric exercises, each held for 10 seconds with brief rest intervals, for 5 complete repetitions. The exercises included: (a) Isometric Curl-Up, (b) Side Bridge, and (c) Bird Dog. The total dedicated exercise time was approximately 20 minutes per session.

干预措施: Isometric exercises (Other)

arm2- Group B: Isotonic Exercises

Experimental

Isotonic Exercise Group (ITG): This group performed a circuit of three dynamic, strength-oriented isotonic exercises, each completed for 10 repetitions. The exercises included: (a) Bent Knee Sit-Up, (b) Cross Curl-Up, and (c) Prone Back Extension. The total dedicated exercise time was also approximately 20 minutes per session. All exercises were selected and adapted from previously published rehabilitation protocols for CLBP

干预措施: Isotonic exercises (Other)

结局指标

主要结局

VAS

时间窗: 4 WEEKS

Measured using a 100-mm Visual Analogue Scale , where 0 mm represents "no pain" and 100 mm represents "the worst pain imaginable." Participants marked a point on the line corresponding to their current pain level. The Arabic version of the VAS has been validated as a reliable and responsive tool for pain assessment in clinical populations \[17\].

次要结局

  • MODI(4WEEKS)
  • Muscular Endurance(4WWEKS)

研究者

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

Azzam Alarab

Palestine Ahliya University is located in Jabal Daher, Bethlehem, West Bank, Palestine, with a mailing address of PO Box 1041, Bethlehem, ZIP code 90907

Palestine Ahliya University

研究点 (1)

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