Effectiveness of Integrative PhysiOsteopathic Therapy Combined with Blood Flow Restriction Training for Shoulder Dysfunction Following COVID-19 Vaccination: A Randomized Controlled Trial in the Post-Pandemic Era
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is the intensity of shoulder pain, which will be assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS) at 8 weeks post-intervention. This measure will provide a quantitative assessment of pain reduction and serve as the main indicator of the effectiveness of the integrative Physio-Osteopathic therapy combined with Blood Flow Restriction Training compared to standard physiotherapy care.
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a combined integrative Physio-Osteopathic therapy and Blood Flow Restriction Training (BFRT) program in adults aged 20–50 years who develop shoulder pain within 4 weeks of COVID-19 vaccination. The intervention targets complex shoulder dysfunction, including supraspinatus tendinosis, posterior capsule and pectoralis minor tightness, and cervical involvement (SCM, upper trapezius, C4 facet joint tenderness). Participants in the experimental group will receive joint mobilization, myofascial release, cervical mobilization, scapular stabilization exercises, and low-load BFRT for rotator cuff, deltoid, and scapular stabilizers. The control group will receive standard physiotherapy care including stretching, strengthening, posture correction, and activity modification. The primary outcome is pain intensity measured by VAS/NRS at 8 weeks. Secondary outcomes include shoulder and cervical range of motion, functional disability (DASH or SPADI), muscle strength, quality of life (SF-36 or EQ-5D), sleep quality (PSQI), and patient satisfaction. The study duration is 8 weeks of intervention with follow-up at 12 weeks. This trial will provide high-quality evidence on the efficacy of a multi-modal rehabilitation approach for post-vaccination shoulder dysfunction in the post-pandemic era.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants eligible for the study will be adults aged between 20 and 50 years who develop shoulder pain within 4 weeks following COVID-19 vaccination.
- •Clinical examination must reveal one or more of the following: supraspinatus tendinosis, posterior capsule tightness, pectoralis minor tightness, or cervical involvement such as sternocleidomastoid or upper trapezius hypertonicity.
- •All participants must be willing and able to provide written informed consent prior to enrollment in the study.
排除标准
- •Participants will be excluded if they have a history of prior shoulder surgery on the affected side or have experienced severe shoulder or cervical trauma.
- •Individuals with neurological disorders affecting the upper limb will also be excluded, as will those with contraindications to Blood Flow Restriction Training (BFRT), including vascular disorders, uncontrolled hypertension, or clotting disorders.
- •Pregnant or breastfeeding women will not be eligible to participate in the study.
结局指标
主要结局
The primary outcome of the study is the intensity of shoulder pain, which will be assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS) at 8 weeks post-intervention. This measure will provide a quantitative assessment of pain reduction and serve as the main indicator of the effectiveness of the integrative Physio-Osteopathic therapy combined with Blood Flow Restriction Training compared to standard physiotherapy care.
时间窗: Baseline Assessment, 8 weeks, and 12 weeks follow-up
次要结局
- Shoulder and cervical range of motion, functional disability (DASH or SPADI), muscle strength of rotator cuff and scapular stabilizers, quality of life (SF-36 or EQ-5D), sleep quality (PSQI), and patient satisfaction.(Baseline Assessment, 8 weeks, and 12 weeks follow-up)
研究者
Dr Ramesh Chandra Patra
Lovely Professional University Faculty of Applied Medical Sciences