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临床试验/CTRI/2026/01/100874
CTRI/2026/01/100874尚未招募不适用

Effect of Low-Load Blood Flow Restriction Training on Pain, Range of Motion, and Strength in Individuals with Frozen Shoulder: A Randomised Controlled Trial

Dr.Bansi Prajapati (self funded)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1

研究概览

简要总结

**INTRODUCTION:**Frozen shoulder (FS) is an unknown intrinsic disease associated with spontaneously progressive inflammation and fibrosis of the shoulder joint capsule, characterized by pain and significant loss of active and passive shoulder motion. The term "frozen shoulder" was given by Codman in 1934, suggesting that shoulder pain and stiffness could develop independently of outside influences. Frozen shoulder is either primary (idiopathic), developing gradually without a known cause, or secondary, resulting from predisposing factors. which is classified as Stage I – Freezing/Painful (10–36 weeks),Stage II – Frozen/Stiffening (4–12 months),Stage III – Thawing/Resolution (5–26 months). It is a prevalent condition, impacting roughly 2–5% of the general population, primarily adults aged 40 to 60 years, with 70% of cases occurring in females. According to previous studies,20% of patients with diabetes are affected by frozen shoulder, compared to 3–5% of the normal population. clinical features are gradual onset of deep, poorly localized shoulder pain and progressive stiffness are the hallmarks of frozen shoulder, a clinical diagnosis that frequently interferes with sleep and limits everyday activities like dressing or reaching overhead. The defining characteristic is a noticeable limitation of both active and passive range of motion, especially external rotation, followed by flexion, abduction, and internal rotation. Examining the patient may reveal generalized tenderness, loss of arm swing, and occasionally deltoid atrophy. Usually, the patient has no history of significant trauma or surgery. Functionally significant limitation of motion, the lack of significant structural pathology on radiographs, and the exclusion of other conditions like arthritis or rotator cuff tears are all important components of the diagnostic criteria. Although imaging tests like MRI can show capsular thickening and decreased joint volume, their primary purpose is to rule out other possible causes rather than to confirm the diagnosis. It can be treated with both non-operative and operative methods. Non-operative approaches such as patient education, activity modification, oral anti-inflammatory drugs, corticosteroid injections, and hydrodilatation are commonly used in the early stages to control pain and improve mobility. If symptoms persist despite conservative care, operative procedures like manipulation under anesthesia or arthroscopic capsular release may be performed.And Conservative management include supervised range of motion and stretching exercises targeting the shoulder’s flexion, abduction, and external rotation, as well as mild glenohumeral joint mobilization procedures. Strengthening exercises are added subsequently to improve shoulder stability and functional recovery, while heat therapy and other physical modalities may be utilized as adjuncts to reduce discomfort and muscle guarding prior to exercise. Blood flow restriction training (BFRT) is a method that promotes muscle strength and hypertrophy under low-load conditions by applying appropriate blood flow restriction. In recent years, the clinical application of BFRT has become increasingly widespread, demonstrating positive effects in musculoskeletal rehabilitation. Studies have shown that combining BFRT with low-intensity resistance training can significantly improve muscle strength and endurance while reducing joint stress associated with high-load training and lowering the risk of injury. The mechanisms of BFRT may involve increased metabolic stress, altered muscle fiber recruitment patterns, and the promotion of endogenous growth factors such as insulin-like growth factor-1 (IGF-1), which enhances muscle protein synthesis, thereby improving function, strength, and range of motion.

Need of the study: Conservative management in the frozen shoulder are exercises to improve the range of motion of the shoulder joint and to strengthen the surrounding muscles. But, in conservative management Excessive manual pressure may not only hurt but can also cause microtrauma, bruising, or inflammatory flares, and patients may also experience severe pain during treatment, so they may develop fear-avoidance beliefs which leads to worsen disability, prolong recovery, and reduce treatment adherence. While As a low-load BFRT enables muscle strength and hypertrophy with much lower loads than traditional conservative methods, potentially making it safer and more tolerable for patients. However, there are very less evidence and guidelines which focuses on the shoulder itself (frozen shoulder).So there is need for the study to check the effectiveness of the low load blood flow restriction training on the pain, ROM and the strength in individual with frozen shoulder.

METHODOLOGY: This will be a randomized controlled study. The patients will be selected as per the inclusion and exclusion criteria. Once patients agree to participate in the study patient information sheet will be given and written informed consent will be taken from all the selected subjects. Then patients will be allocated randomly into two groups through computer-generated random numbers. Patients will be divided into 2 groups : (A) control group (conventional Physiotherapy) and (B) experimental group (Low Load Blood Flow Restriction Training).Before starting the intervention, all patient’s baseline data will be collected as per case report sheet. Both group will receive physiotherapy for 1 week. All the outcome measures will be before and at the end of intervention.

**OUTCOME MEASURE:**Numerical pain rating scale(NPRS) for pain assessment, Goniometer for ROM,1RM for strength,Shoulder pain and disability index (SPADI) for functional disability.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age 40 to 60 years old Patients reported local shoulder pain, frequently present over either the anteromedial aspect of the shoulder extending distally into the biceps region, or over the lateral aspect of the shoulder extending into the lateral deltoid region.
  • Symptoms present for at least three months.
  • Spontaneous onset of a painful stiff shoulder Marked loss of active and passive global shoulder motion, with at least 50% loss of external rotation Normal x-rays on anteroposterior and axillary radiographs of the glenohumeral joint.

排除标准

  • Shoulder trauma (rotator cuff injury, etc.).
  • Co-occurrence of other neurological or mental disorders (severe cardiac, pulmonary or renal dysfunction, etc.).
  • A previous shoulder surgery.
  • In additional treatments and medications.
  • Contraindications to joint mobilization (e.g. osteoporosis).
  • Rheumatic diseases (eg.rheumatoid arthritis).
  • In connection with systemic diseases such as thyroid diseases.

研究者

发起方
Dr.Bansi Prajapati (self funded)
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nirav Vaghela

K.M Patel Institute of Physiotherapy

研究点 (1)

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