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CTRI Number  CTRI/2025/09/094398 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to find out if manual therapy and low-load strength training can reduce shoulder pain and improve movement in people who developed shoulder problems after COVID-19 vaccination. 
Scientific Title of Study   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 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Chandra Patra 
Designation  Professor 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Block 4, Room no 105, Department of Physiotherapy, Division of Applied Medical Sciences, Lovely Professional University.

Kapurthala
PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  ramesh.19500@lpu.co.in  
 
Details of Contact Person
Scientific Query  
Name  Mohammad Sarfroz 
Designation  PG Student 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, Block 4, Room no 105

Kapurthala
PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  rafiqsarfroz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Chandra Patra 
Designation  Professor 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Department of Physiotherapy, Division of Applied Medical Sciences, Lovely Professional University.

Kapurthala
PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  ramesh.19500@lpu.co.in  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Division of Applied Medical Sciences, Lovely Professional University, Punjab, INDIA. PIN- 144411  
 
Primary Sponsor  
Name  Dr Ramesh Chandra Patra 
Address  Uni Hospital, Department of Physiotherapy, Division of Applied Medical Sciences, Lovely Professional University, Punjab, India. PIN-144411  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nill   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh Chandra Patra  Dr Ramesh Chandra Patra  Block 4, Room no 105, Uni Hospital, Department of Physiotherapy, Division of Applied Medical Sciences, Lovely Professional University, Punjab, India. PIN-144411
Kapurthala
PUNJAB 		 09653174563

ramesh.19500@lpu.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Lovely Professional University, Punjab  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M255||Pain in joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator Intervention (Standard Physiotherapy Care):  Participants in the control group will receive conventional physiotherapy care focused on the management of post-vaccination shoulder dysfunction. This includes supervised stretching and strengthening exercises targeting the shoulder and periscapular muscles without the use of Blood Flow Restriction Training (BFRT). Exercises will aim to improve shoulder range of motion, enhance muscle activation, and reduce pain, while promoting gradual functional recovery. Additionally, participants will receive education on activity modification, posture correction, and ergonomics to minimize aggravation of symptoms. Sessions will be conducted 2–3 times per week over an 8-week period, with each session lasting approximately 45–60 minutes. Progression of exercises will be individualized based on patient tolerance and functional improvements. Adverse events will be monitored throughout the intervention period. 
Intervention  Physio-Osteopathic Therapy Combined with Blood Flow Restriction Training   Duration of Intervention: 8 weeks. Participants in the experimental group will receive a combined rehabilitation program consisting of integrative Physio-Osteopathic therapy and low-load Blood Flow Restriction Training (BFRT). The Physio-Osteopathic component includes posterior-anterior glides of the glenohumeral joint to improve joint mobility, myofascial release targeting the pectoralis minor, upper trapezius, and cervical fascia to reduce soft tissue restrictions, and cervical mobilization addressing the sternocleidomastoid (SCM) and C4 facet joints to alleviate cervical involvement. Additionally, scapular stabilization and posture correction exercises will be incorporated to optimize shoulder mechanics and postural alignment. The BFRT component involves low-load resistance exercises performed at 20–30% of one-repetition maximum (1RM) for key muscles including the rotator cuff, deltoid, and scapular stabilizers. Training sessions will be conducted 2–3 times per week over an 8-week period. Safety monitoring during BFRT will include regular assessment of blood pressure, limb perfusion, and observation for any adverse events to ensure patient safety and tolerability throughout the intervention period. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.  Baseline Assessment, 8 weeks, and 12 weeks follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/09/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   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. 
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