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Clinical Trials/CTRI/2025/07/091074
CTRI/2025/07/091074
Not yet recruiting
Not Applicable

Pain Relief and Functional Recovery After Shoulder Manipulation Under Interscalene vs. Combined Suprascapular and Axillary Nerve Blocks in Frozen Shoulder: A Randomized non inferiority Trial

Jawaharlal Institute of Postgraduate Medical Education and Research1 site in 1 country142 target enrollmentStarted: July 27, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
142
Locations
1
Primary Endpoint
change in SPADI score after 4weeks month following

Overview

Brief Summary

After obtaining approval from the Post-graduate Research Monitoring Committee and JIPMER ethics committee (human studies), and completing Clinical Trial Registry India(CTRI) registration, patients fulfilling the eligibility criteria will be recruited for the study after obtaining written informed consent. Baseline recording of SPADI score, Constant Murley Shoulder outcome score will be taken. The patients will be randomly allocated into 2 groups, Group 1 (receiving Suprascapular nerve block and axillary nerve block), Group 2 (interscalene nerve block alone) . Prior to any intervention, the patient will be assessed with Shoulder Pain and Disability score (SPADI) and Constant-Murley Shoulder outcome score. (6) . The need for pain medication will be assessed using the Medication Quantification Scale (MQS III). All standard ASA monitors including non-invasive blood pressure, pulse oximetry, ECG will be attached. Baseline hemodynamic parameters like heart rate, blood pressure and spo2 will be recorded. An appropriately sized IV cannula will be secured. Patients belonging to Group 1 will receive ultrasound guided Suprascapular nerve block and axillary nerve block. With the patient in sitting position, Suprascapular nerve will be blocked at the level of suprascapular notch with 5 ml of 0.5%Bupivacaine after identifying the suprascapular artery using doppler. Axillary nerve is blocked at the quadrilateral space with 5 ml of 0.5%Bupivacaine after identifying the posterior circumflex humeral artery. Patients belonging to group 2 will receive ultrasound guided Interscalene brachial plexus blocks with 10 ml of 0.5% Bupivacaine, with the patient in supine position and head turned slightly to the opposite side. Blocks will be performed by a person who has done at least 50 USG guided nerve blocks. After 15 minutes of giving the block, Orthopedic surgeon/ Physical therapist involved in the study will do the shoulder manipulation using Codman’s paradox method. One orthopaedic surgeon and one physical therapist have been involved in the study and the manipulation will be done by one of them. It includes three consecutive 90° rotations - elevation, swing, and descending movements. (1) Starting position: The patient hangs his or her arm along the side with the thumb pointing forward and fingers pointing toward the ground. (2) Elevation (first move): The arm is elevated 90° in the sagittal plane without rotation about the humeral shaft axis (i.e. thumb points upward and fingers point forward). (3) Swing (second move): The arm is moved 90° to the coronal plane without rotation about the humeral shaft axis (i.e. fingers now point to the right or left for the right and left shoulders, respectively). (4) Descending (third move): Finally, the arm is lowered 90° downward (i.e. fingers point to the ground). After these three rotations, the patient will notice that the thumb points to the right or left (for the right and left shoulders, respectively), which means that the arm has rotated by 90°. Patients in both groups will be given intraarticular Methylprednisolone injection 40 mg in volume of 10 ml after the shoulder manipulation.Clinician assessment Patients will be observed until the block effect wears out. Any complications will be noted and satisfactory manipulation using Likert scale will be noted. SPADI and Constant-Murley Shoulder outcome score will be noted after 4 hours of the procedure. Patients will be advised to continue physiotherapy and RoM exercises. Patients will be reviewed every week on telephone to motivate them to continue physiotherapy. After 1 month the patient will be reviewed in pain clinic to assess SPADI, Constant-Meyer Shoulder outcome score and pain medication requirement using MQS III scale will be noted.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age 18 years to70 years.
  • ASA class 1 & 2
  • Patients diagnosed with frozen shoulder having shoulder pain and reduced range of motion for 3 months.

Exclusion Criteria

  • Previous shoulder surgery
  • Interventional pain procedures for shoulder pain in the last 6 months
  • Cervical spine disease
  • Patients suspected with rotator cuff injuries
  • Bleeding disorders
  • Allergy to the local Anesthetics
  • Local site infection.

Outcomes

Primary Outcomes

change in SPADI score after 4weeks month following

Time Frame: SPADI score at Baseline and 4 weeks month post intervention

shoulder manipulation

Time Frame: SPADI score at Baseline and 4 weeks month post intervention

Secondary Outcomes

  • 1. To assess the satisfaction of the clinician performing the after 4 hr(shoulder manipulation using a Likert scale)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Anjali Dutta

Jawaharlal Institute of Postgraduate Medical Education & Research

Study Sites (1)

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