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临床试验/NCT04834271
NCT04834271撤回不适用

Effects of Blood Flow Restriction Training on Central Mechanisms of Pain Modulation in Subjects With Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial

University of Alcala2 个研究点 分布在 1 个国家开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Conditioned Pain Modulation (CPM)

研究概览

简要总结

Blood flow restriction training is widespread in sport performance areas, where it has proven to be beneficial in strength and hypertrophy development. However, there are only few studies related to its effects on subjects with pathology, and currently, there is no recent clinical trial evaluating its effects on patients with RCRSP. We are aiming to define the potential benefits, acute and short-term effects of adding blood flow restriction to a low-load exercise training for patients with RCRSP.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Pain around the antero-lateral (deltoid area) region of the proximal shoulder during active movements in abduction and/or external rotation.
  • 3/5 positive impingement tests: Neer, Hawkins-Kennedy, empty can, painful arc, and resisted external rotation or abduction.
  • Pain at rest less than 3cm in a visual analogue scale (VAS).

排除标准

  • Previous shoulder surgery.
  • Being treated with physical therapy or pharmacogical therapy for shoulder pain.
  • External rotation range of motion less than 45º or 50% compared to the contralateral side.
  • Suspected shoulder instability (previous dislocation/subluxation, sulcus sign, anterior drawer test, anterior/posterior aprehension test, relocation test).
  • Suspected cervical radiculopathy (distraction, spurling, ULNT1, squeeze test, ipsilateral rotation less than 60º)
  • Presence of neck pain.
  • Suspected rotator cuff tears (drop arm test, external rotation lag sign, diagnostic imaging).
  • Contraindications to blood flow restriction therapy.

结局指标

主要结局

Conditioned Pain Modulation (CPM)

时间窗: Baseline, immediately after the first treatment session, 1 month, and 2 months

Conditioned pain modulation estimated using changes in pressure pain threshold measured with a manual algometer and a sphygmomanometer.

次要结局

  • Pain intensity(Baseline, 1 month, and 2 months)
  • Shoulder pain and disability index (SPADI)(Baseline, 1 month, and 2 months)
  • Pain-free isometric strength(Baseline, immediately after the first treatment session, 1 month, and 2 months)

研究者

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

Ruben Fernandez Matias

Clinical Professor

University of Alcala

研究点 (2)

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