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CTRI Number  CTRI/2026/01/100874 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparison of Low-Load Blood Flow Restriction Training and Conventional Physiotherapy for Pain, Range of Motion, and Strength in Patients with Frozen Shoulder. 
Scientific Title of Study   Effect of Low-Load Blood Flow Restriction Training on Pain, Range of Motion, and Strength in Individuals with Frozen Shoulder: A Randomised Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirav Vaghela 
Designation  Professor and Vice Principal 
Affiliation  K.M Patel Institute of Physiotherapy 
Address  Shree krishna Hospital,K.M Patel Institute of Physiotherapy,OPD no.152,Karamsad Anand Gujarat India-388325

Anand
GUJARAT
388325
India 
Phone  9428647304  
Fax    
Email  niravpv@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bansi Prajapati 
Designation  MPT Student 
Affiliation  K.M Patel Institute of Physiotherapy 
Address  Shree krishna Hospital,K.M Patel Institute of Physiotherapy,OPD no.152,Karamsad Anand Gujarat India-388325

Anand
GUJARAT
388325
India 
Phone  09925826710  
Fax    
Email  prajapatibansi49@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bansi Prajapati 
Designation  MPT Student 
Affiliation  K.M Patel Institute of Physiotherapy 
Address  OPD No. 152, Department of Physiotherapy,K.M. Patel Institute of Physiotherapy, Shree Krishna Hospital, Karamsad, Anand, Gujarat, India – 388325

Anand
GUJARAT
388325
India 
Phone  09925826710  
Fax    
Email  prajapatibansi49@gmail.com  
 
Source of Monetary or Material Support  
Kinesiotherapy and Electrotherapy unit of physiotherapy department of K. M. Patel Institute of Physiotherapy, Shree krishna hospital, Karamsad, Gujarat, India 388325 
 
Primary Sponsor  
Name  Dr.Bansi Prajapati (self funded) 
Address  K. M. Patel Institute of Physiotherapy, Shree krishna hospital, Karamsad, Gujarat, India 388325 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirav Vaghela  K.M patel institute of physiotherapy   OPD No. 152, Department of Physiotherapy,K.M. Patel Institute of Physiotherapy, Shree Krishna Hospital, Karamsad, Anand, Gujarat, India – 388325
Anand
GUJARAT 
9428647304

niravpv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE -2 Bhaikaka University, Karamsad, Anand, Gujarat-388325 [DHR Reg. No. EC/NEW/INST/2021/592] [OHRP Reg. No. IRB00014178]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional physiotherapy  The total duration of each session is approximately 30 minutes.For one week,the physiotherapy program includes application of a moist heat pack for 10 minutes, followed by capsular stretching of the anterior, posterior, and inferior capsule (30-second hold, 3 sets each). Glenohumeral joint mobilization, including caudal glide and posteroanterior glide, is performed at a rate of 2–3 glides per second for 30 seconds, with 3 sets each. Strengthening exercises are carried out using dumbbells at low intensity (20–30% of 1RM) with 10 repetitions for 3 sets, including shoulder flexion, standing shoulder extension, standing scaption, side-lying external rotation, and standing internal rotation. Shoulder mobilization exercises consisting of pulley exercises, finger ladder exercises, circumduction exercises, and pendulum exercises are also performed for 10 repetitions. 
Intervention  Low-Load Blood Flow Restriction Training  The total duration of each session is approximately 30 minutes.For one week,the physiotherapy program consists of a 10-minute moist heat pack followed by capsular stretching of the anterior, posterior, and inferior capsule(30-second hold, 3 sets each). Glenohumeral joint mobilization, including caudal and posteroanterior glides, which performed at a rate of 2–3 glides per second for 30 seconds, with 3 sets each. Then Strengthening is carried out using manual blood flow restriction cuff, which applied proximally on the affected arm at a pressure of 61 mmHg. With that Low-load resistance(20–30% of 1RM) dumbbell exercises are given which include supine shoulder flexion, standing shoulder extension and scaption, side-lying external rotation, and standing internal rotation(10 repetitions, 3 sets each, with 30–60 seconds rest).Shoulder mobilization exercises, consisting of pulley exercises, finger ladder exercises, circumduction exercises, and pendulum exercises, are also performed for 10 repetitions. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical pain rating scale(NPRS)  Outcome measures are assessed at two time points at baseline after participant enrolment & one week after completion of the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Universal Goniometer for Range of Motion
 
Outcome measures are assessed at two time points at baseline after participant enrolment & one week after completion of the intervention. 
1 RM for Strength  Outcome measures are assessed at two time points at baseline after participant enrolment & one week after completion of the intervention. 
Shoulder Pain & Disability Index (SPADI)  Outcome measures are assessed at two time points at baseline after participant enrolment & one week after completion of the intervention. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.

 
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