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CTRI Number  CTRI/2026/02/102805 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 02/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Prospective Interventional Study]  
Study Design  Single Arm Study 
Public Title of Study   In patients having restriction in shoulder joint movement and pain due to soft tissue lesions, ultrasound guided highly concentrated dextrose solutions with property of healing, will be injected in the soft tissues, for improvement in movement with reduction in associated chronic pain.  
Scientific Title of Study   Effect of Ultrasound-guided Hypertonic Dextrose Prolotherapy on Functional Outcomes in Patients with Rotator Cuff Pathology 
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 Riya Aggarwal 
Designation  Junior Resident  
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9478654169  
Fax    
Email  riyaaggarwal048@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dheeraj Kapoor 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive care, Block D Room no 523 , Level 5, GMCH, Sector 32-B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121549  
Fax    
Email  kapoor.dheeraj72@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Riya Aggarwal 
Designation  Junior Resident  
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive care, Block D, Level 5, GMCH, Sector 32-B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9478654169  
Fax    
Email  riyaaggarwal048@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh, India, PIN code - 160030 
 
Primary Sponsor  
Name  Government Medical College and Hospital 
Address  Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh, India, PIN code - 160030 
Type of Sponsor  Government medical college 
 
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 Riya Aggarwal  Government Medical College and Hospital  Department of Anaesthesia and Intensive care, Block D, Level 5, Government Medical College and Hospital, Sector 32-B, Chandigarh, India, PIN code - 160030
Chandigarh
CHANDIGARH 		 9478654169

riyaaggarwal048@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMCH, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M678||Other specified disorders of synovium and tendon,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Ultrasound-guided Hypertonic Dextrose Prolotherapy  In this study, we will do your screening and a pre-intervention checkup will be done. Patient will be shifted to interventional pain room in the operation theatre complex, intravenous access will be secured for any emergency drugs, vital monitoring will be done according to the standard ASA guidelines. The procedure is guided via using the ultrasound imaging. Local anaesthesia will be given at the site of needle insertion and may require conscious sedation. Hypertonic dextrose (12.5 percent) will be given by special Stimuplex needle, which will be introduced in your shoulder under local anaesthesia and with all aseptic precautions. After the procedure for next 30 minutes in the recovery room, patients vitals will be monitored and occurrence of any adverse events will be observed and managed. Shoulder pain and disability index (SPADI), Active Range of motion (AROM), overall shoulder satisfaction by Likert scale, VAS-week and average number of rescue analgesia will be assessed 1, 2 and 3 months after third prolotherapy session. We will also assess muscle strength by MRC grading scale prior to first and then at 3 months, after third prolotherapy session. Any adverse events peri intervention and post- intervention will be recorded. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with chronic shoulder pain of more than 3 months of duration, with Rotator cuff pathology as confirmed by definitive clinical diagnosis ( history and physical examination, including special test- Neer, Hawkins-Kennedy and drop arm test.)
2. Magnetic resonance imaging (MRI) confirming the evidence of RC pathology (partial thickness tear, tendinosis and/or bursitis ) and having strong correlation with physical examination findings.
3. Age range between 18 and 70 years. 
 
ExclusionCriteria 
Details  1. Previous shoulder surgery.
2. Full thickness rotator cuff lesions on MRI scan.
3. Shoulder fracture within past 6 months.
4. Patient having calcific tendinitis, adhesive capsulitis or glenohumeral osteoarthritis.
5. Patient with inflammatory and systemic rheumatic disorders.
6. Pregnant and lactating women.
7. Severe bleeding diathesis or on anticoagulation therapy.
8. Patient with severe systemic illness ( heart, lung, hepatic, renal , psychiatric , connective tissue disorder, neurological, uncontrolled diabetes mellitus or hypertension.)
9. Presence of systemic infection or local infection at the injection site.
10. Significant allergic reaction or hypersensitivity to corticosteroid, local anaesthetic, or dextrose.
11. Patient diagnosed with malignancy.
12. Unwillingness to abstain from NSAIDS for at least 3 days post-intervention
13. Patient taken any mode of corticosteroid therapy (systemic, injection) in past 2 months.
14. Presence of joint prosthesis or joint instability.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Shoulder Pain and Disability Index (SPADI) score   Baseline Shoulder Pain and Disability Index (SPADI) score and 1, 2, and 3 months after third prolotherapy session 
 
Secondary Outcome  
Outcome  TimePoints 
Active range of motion ( abduction, forward flexion, internal rotation, external rotation of shoulder measured by goniometer( angle at onset of pain will be measured three times to obtain median value)   Baseline Active range of motion and at 1, 2, and 3 months after third prolotherapy session 
Overall shoulder satisfaction measured by Likert scale  At 1, 2, and 3 months after third prolotherapy session 
Average shoulder pain at movement in preceding 1 week measured by visual analogue scale ( VAS- week)   Baseline VAS- week and at 1, 2, and 3 months after third prolotherapy session 
Muscle strength testing measured by medical research council scale (MRC)   Baseline muscle strength and at 3 months after third prolotherapy session 
Any adverse events  Recorded peri ntervention and post 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   Phase 4 
Date of First Enrollment (India)   16/02/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Chronic shoulder pain is one of the common upper extremity musculoskeletal disorders frequently seen in outpatient and orthopaedic clinics. Among the numerous causes of chronic shoulder pain, Rotator cuff pathology is the most common, particularly over the 30 years of age. Corticosteroid injections in shoulder area are conventionally used to decrease pain and improve functional outcome in rotator cuff lesions. They suppress inflammation and help reducing pain but these injections have adverse outcomes on tendon repair and natural healing. They have side effects such as tendon weakening or rupture, skin hypopigmentation, sub cutaneous fat atrophy, severe allergic reaction and systemic steroid exposure. In our study, we will be giving hypertonic dextrose injections, which promote natural healing of the tissues and is devoid of known side effects associated with corticosteroids. Dextrose prolotherapy involves injection of small volumes of an irritant solution , most commonly hypertonic dextrose , into painful or degenerated tendon and ligament insertions. We will give three sessions at 2 weeks intervals, to promotes natural healing during the course of time. In this study, we are evaluating the efficacy of hypertonic dextrose injections (12.5%) in improving functional outcomes in various rotator cuff pathologies, under the guidance of ultrasound for enhancing the precision of point of injection.

Aim


To observe the effectiveness of ultrasound guided hypertonic dextrose prolotherapy injections on functional outcomes in patients with rotator cuff pathology


Objectives


1. To observe the effectiveness of dextrose prolotherapy sessions on improvement of pain and reduction in disability in activities of daily living as measured by Shoulder pain and disability index (SPADI) score in patients with rotator cuff pathology.

2. To observe the improvement in active range of motion (AROM) as measured by goniometer after three dextrose prolotherapy sessions

3. To observe the  improvement in patient satisfaction outcomes achieved after three dextrose prolotherapy sessions using five point Likert scale.

4. To observe the analgesic efficacy of dextrose prolotherapy using visual analogue scale (VAS).

5. To observe the improvement in muscle strength after administering 3 dextrose prolotherapy sessions, using medical research council scale (MRC).

6. To record any adverse events peri and post intervention.


Methodology

In this study we will do screening and a pre intervention checkup will be done. Patient will be shifted to interventional pain room in the operation theatre complex , intravenous access will be secured for any emergency drugs, vital monitoring will be done according to the standard ASA guidelines. The procedure is guided via using the ultrasound imaging.Local anaesthesia will be given at the site of needle insertion and may require conscious sedation. The desired skin will be prepared aseptically with 10 percent povidone iodine solution .All ultrasound images and subsequent injection therapy will be performed by same experienced pain interventionist. A high frequency linear ultrasound probe (5-10 MHz) will be positioned to obtain the desired view of the affected shoulder joint as per ASAP protocol. Under ultrasound guidance , the hypoechoic (tendinosis, bursitis) and/or hypo echoic with anechoic focus/cleft (partial thickness tear) will be identified as the pathology. After obtaining the desired ultrasound image of the affected area, local infiltration with maximum of 2 ml of 2 percent preservative free lignocaine hydrochloride will be given at the entry site and the intended tract using 26-gauge needle (0.5 mm length) and 22-guage stimuplex A needle will be advanced in-plane under ultrasound to the target. At each affected site (hypo echoic/ anechoic site of the tendon) after obtaining the long/short axis view, dry needling of the area of tendinosis was performed with 22-guage stimuplex A needle prior to the peri- and/or intra-tendinous and corresponding bursa injection of the prolotherapy solution. Following dry needling, maximum of 2 ml of prolotherapy solution ( 1 ml 25 percent dextrose and 1 ml of 1 percent lignocaine will be injected following negative aspiration each site. multiple sites may be injected , with total volume ranging from 2-20 ml. After completion of procedure , the needle will be withdrawn and a sterile dressing will be applied. Following the procedure, patient will be kept supine in the recovery room for 30 minutes with continuous monitoring of vitals. Patients will be given post procedural written instructions about analgesia and home exercises to be done.Shoulder pain and disability index (SPADI), Active Range of motion (AROM), overall shoulder satisfaction by Likert scale, VAS-week and average number of rescue analgesia will be assessed 1, 2 and 3 months after third prolotherapy session. We will also assess muscle strength by MRC grading scale prior to first and then at 3 months, after third prolotherapy session. Any adverse events peri intervention and post- intervention will be recorded.
 
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