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CTRI Number  CTRI/2026/01/100431 [Registered on: 06/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare the effect of Dextrose versus Normal saline in Trapezius muscle pain 
Scientific Title of Study   Effectiveness of Dextrose Prolotherapy Versus Normal Saline in Myofascial Trigger Points in the Trapezius Muscle: A Single Blinded Randomized 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 Satyasheel Singh Asthana  
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli  
Address  Room 28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satyasheel Singh Asthana  
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli  
Address  Room 28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satyasheel Singh Asthana  
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli  
Address  Room 28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  9169385726  
Fax    
Email  satyapmr2015@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh 
Address  Room 28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Uttar Pradesh 229405 
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 Satyasheel Singh Asthana   All India Institute of Medical Sciences, Raebareli   Room 28, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Uttar Pradesh 229405
Rae Bareli
UTTAR PRADESH 
9169385726

satyapmr2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), AIIMS Raebareli   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% normal saline  Injection 4 mL of 0.9% normal saline solution with Standard Rehabilitation- The intervention will be performed in a controlled clinical setting (Minor OT) under full aseptic precautions. Using a high-resolution ultrasound probe (5–12 MHz linear transducer), the affected muscle will be scanned to identify the myofascial trigger point (MTrP), characterized by a focal hypoechoic or stiff nodule within the muscle belly associated with local tenderness on palpation. The skin will be sterilized using 2% chlorhexidine solution, and a 25-gauge, 1.5-inch needle attached to a 5 mL syringe will be introduced under real-time ultrasound guidance using the in-plane approach. Once the needle tip reaches the target point (Muscle twitch may occur), negative aspiration will be performed to rule out intravascular placement. The injectate (4 mL of 0.9% normal saline solution ) will then be administered using the fanning technique, in which the needle tip is redirected in multiple directions within the same tissue plane without complete withdrawal from the skin. Approximately 0.5–1 mL of injectate will be delivered at 3–4 sites within the identified trigger point to ensure uniform distribution of the solution and adequate muscle coverage. Both the groups will receive standard rehabilitation services that include postural care or correction, activity modifications or ergonomic changes and therapeutic exercises (Stretching of trapezius muscle)  
Intervention  5% dextrose solution  Injection 4 mL of 5% dextrose solution with Standard Rehabilitation- The intervention will be performed in a controlled clinical setting (Minor OT) under full aseptic precautions. Using a high-resolution ultrasound probe (5–12 MHz linear transducer), the affected muscle will be scanned to identify the myofascial trigger point (MTrP), characterized by a focal hypoechoic or stiff nodule within the muscle belly associated with local tenderness on palpation. The skin will be sterilized using 2% chlorhexidine solution, and a 25-gauge, 1.5-inch needle attached to a 5 mL syringe will be introduced under real-time ultrasound guidance using the in-plane approach. Once the needle tip reaches the target point (Muscle twitch may occur), negative aspiration will be performed to rule out intravascular placement. The injectate (Injection 4 mL of 5% dextrose solution ) will then be administered using the fanning technique, in which the needle tip is redirected in multiple directions within the same tissue plane without complete withdrawal from the skin. Approximately 0.5–1 mL of injectate will be delivered at 3–4 sites within the identified trigger point to ensure uniform distribution of the solution and adequate muscle coverage. Both the groups will receive standard rehabilitation services that include postural care or correction, activity modifications or ergonomic changes and therapeutic exercises (Stretching of trapezius muscle)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age group Eighteen to sixty five years
Diagnosis based on international consensus criteria.
Palpable taut band and hypersensitive spot reproducing pain.
Duration of disease more than three months
NPRS more than or equal to five
 
 
ExclusionCriteria 
Details  Cervical radiculopathy, fibromyalgia, systemic infection, coagulopathy.
Pregnancy and lactation.
Prior injection in same area
Prior steroid injection within six months
Rheumatological disorders
History of injury in neck or shoulder region
Undergoing or recently taken any medication or therapy related to psychiatric or psychological issues
Uncontrolled Hypertension and Diabetes
Refusal to give consent or take part in study
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale (NPRS)  Baseline, 1 week, 1 month, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
WHOQOL-BREF questionnaire   Baseline, 3 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   27/01/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Background

Muscular Trigger points is a major contributor to chronic musculoskeletal pain, leading to significant disability, reduced quality of life, and socioeconomic burden. Despite the high prevalence, its management often remains empirical, with inconsistent results from conventional therapies such as oral medications, physical therapy, and blind trigger point injections.

By systematically evaluating the outcomes of ultrasound-guided dextrose injection versus normal saline in patients with MPS, this study aims to generate robust clinical evidence to guide treatment selection and standardize interventional protocols. The findings are expected to help clinicians adopt evidence-based, safe, and cost-effective management strategies that can enhance pain relief, restore function, and improve overall quality of life in patients suffering from chronic myofascial pain.

Specific Objectives

Primary Objective: To compare the reduction in pain intensity between dextrose prolotherapy and normal saline injection groups at 1 week, 1 month, and 3 months post-intervention using the Numeric Pain Rating Scale (NPRS).

Secondary Objective: To compare improvement in Quality of Life using the World Health Organization Quality of Life Questionnaire-BREF (Hindi version).

Methodology

Design: Single Blinded Randomized control trial

Duration: 2 years

Setting: Outpatient Department (OPD) of Department of Physical Medicine & Rehabilitation, AIIMS Raebareli.

Participants:

Inclusion criteria

Age group Eighteen to sixty five years

Diagnosis based on international consensus criteria.

Palpable taut band and hypersensitive spot reproducing pain.

Duration of disease more than three months

NPRS more than or equal to five

Exclusion criteria

Cervical radiculopathy, fibromyalgia, systemic infection, coagulopathy.

Pregnancy and lactation.

Prior injection in same area

Prior steroid injection within six months

Rheumatological disorders

History of injury in neck or shoulder region

Undergoing or recently taken any medication or therapy related to psychiatric or psychological issues

Uncontrolled Hypertension and Diabetes

Refusal to give consent or take part in study

Sample Size: 36

Procedure

After obtaining informed and written consent, each participant will receive a detailed explanation regarding the purpose of the procedure, potential benefits, risks, and post-procedural care. They will be randomly divided in two groups

Group A (Experimental group): Injection 4 mL of 5% dextrose solution + Standard Rehabilitation

Group B (Control group): Injection 4 mL of 0.9% normal saline + Standard Rehabilitation

The intervention will be performed in a controlled clinical setting (Minor OT) under full aseptic precautions.

Using a high-resolution ultrasound probe (5–12 MHz linear transducer), the affected muscle will be scanned to identify the myofascial trigger point (MTrP), characterized by a focal hypoechoic or stiff nodule within the muscle belly associated with local tenderness on palpation. The skin will be sterilized using 2% chlorhexidine solution, and a 25-gauge, 1.5-inch needle attached to a 5 mL syringe will be introduced under real-time ultrasound guidance using the in-plane approach.

Once the needle tip reaches the target point (Muscle twitch may occur), negative aspiration will be performed to rule out intravascular placement. The injectate (Injection 4 mL of 5% dextrose solution ) will then be administered using the fanning technique, in which the needle tip is redirected in multiple directions within the same tissue plane without complete withdrawal from the skin. Approximately 0.5–1 mL of injectate will be delivered at 3–4 sites within the identified trigger point to ensure uniform distribution of the solution and adequate muscle coverage.

Both the groups will receive standard rehabilitation services that include postural care or correction, activity modifications or ergonomic changes and therapeutic exercises (Stretching of trapezius muscle)

Post-procedure care

After injection, the participant will be observed in the recovery area for 2–4 hours for any immediate complications such as bleeding, dizziness, or allergic reactions. A cold pack may be applied to the injection site if localized soreness occurs. Participants will be advised to avoid vigorous activity on the day of the procedure and to begin gentle stretching exercises after 24 hours to maintain muscle flexibility and prevent stiffness. Analgesics will be avoided unless rescue medication is required; in such cases, acetaminophen 650 mg may be taken on a SOS (as-needed) basis.

Follow-up and Outcome Assessment

Follow-up assessments will be conducted at baseline, 1 week, 1 month, and 3 months post-procedure.

Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS) at all four time points (baseline, 1 week, 1 month, 3 months).

Quality of life will be assessed using the WHOQOL-BREF questionnaire at baseline, 1 month, and 3 months. Any adverse events, recurrence of pain, or need for additional interventions will be documented during each follow-up visit.

This standardized protocol aims to ensure uniformity, procedural safety, and reproducibility of ultrasound-guided trigger point injections for comparative evaluation between dextrose and normal saline.

Randomization and Blinding: Participants randomized 1:1 using computer-generated sequence. Participants will not know about their group allocation and type of intervention therefore it will be Single Blind study. Both injections are transparent in nature. Participants will be informed about both procedures. Assessor will also not know about intervention group. Patient will be informed about their management.

 

 
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