Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair

The Effect of Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair: Randomized Controlled Study

Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .. Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications.

Study Overview

• Status: Recruiting
• Conditions: Pain; Rotator Cuff Tears; Nerve Block
• Intervention / Treatment: Procedure: conventional physiotherapy program.; Procedure: Suprascapular nerve block

Detailed Description

Suprascapular nerve block is an injection method that has been shown to be effective in shoulder rehabilitation in diseases such as adhesive capsulitis and stroke .Applying the block under USG guidance instead of blinding increases the effectiveness and reduces complications There are many studies in the literature on suprascapular, axillary, and interscalene nerve blocks in early pain management after shoulder arthroplasty. All of these focus on pain in the perioperative or early postoperative period. There is a study on USG-guided suprascapular nerve block. In this study, unlike the studies in the literature, it was aimed to show the effectiveness of USG-guided suprascapular nerve block in the subacute rehabilitation process of patients.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Basak Cigdem Karacay, Asst Prof; Phone Number: +9 0386 280 51 00.; Email: basakcigdem@hotmail.com

Study Locations

• Turkey
  • City Centre
    • Kirşehir, City Centre, Turkey, 40100
      • Recruiting
      • Ahi Evran University
      • Contact: Basak Cigdem Karacay, Assist Prof; Phone Number: :+90 386 280 39 00; Email: basak.cigdemkaracay@ahivran.edu.tr
      • Principal Investigator: Basak Cigdem Karacay, Assist Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Having undergone arthroscopic rotator cuff repair surgery within the last week

Exclusion Criteria:

• History of previous surgery on the same shoulder
• History of systemic inflammatory rheumatological disease
• Neurological diseases with muscle weakness in the upper extremity (MS, ALS, Muscular -Dystrophy)
• History of malignancy, pregnancy, breastfeeding
• Use of steroids or immunosuppressive drugs
• History of allergic reactions to local analgesics
• Fibromyalgia syndrome
• Chronic painful conditions that require opioid use
• Presence of known psychiatric disease
• Cognitive impairment (Mini Mental Test Score <23)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; In addition to the conventional physiotherapy program, patients in the intervention group will receive a suprascapular nerve block with musculoskeletal USG guidance available in our clinic at the beginning of rehabilitation. Bupivacaine hydrochloride will be used in this injection. 5 ml of bupivacaine hydrochloride 5% and 5 ml of saline will be drawn into a 10 ml syringe and ejection will be performed from the superior of the suprascapular noch under USG guidance.	Procedure: conventional physiotherapy program.; It will be applied to a rehabilitation program including joint range of motion exercises and physical therapy modalities by a physiotherapist at the Physical Therapy Hospital.; Procedure: Suprascapular nerve block; Bupivacaine hydrochloride will be used in this injection. 5 ml of bupivacaine hydrochloride 5% and 5 ml of saline will be drawn into a 10 ml syringe and ejection will be performed from the superior of the suprascapular noch under USG guidance.
Active Comparator: Control Group; Patients in the control group will only receive a conventional physiotherapy program.	Procedure: conventional physiotherapy program.; It will be applied to a rehabilitation program including joint range of motion exercises and physical therapy modalities by a physiotherapist at the Physical Therapy Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	In the study, pain intensity was evaluated with the Visual Analogue Scale (VAS). Numbers from 0 to 10 on VAS; Patients will be asked to score their pain levels at rest, activity and at night, with 0 being defined as "no pain" and 10 being "unbearable pain". Increased scores indicate higher pain intensity.	Baseline
Visual Analog Scale (VAS)	In the study, pain intensity was evaluated with the Visual Analogue Scale (VAS). Numbers from 0 to 10 on VAS; Patients will be asked to score their pain levels at rest, activity and at night, with 0 being defined as "no pain" and 10 being "unbearable pain". Increased scores indicate higher pain intensity.	6th week
Visual Analog Scale (VAS)	In the study, pain intensity was evaluated with the Visual Analogue Scale (VAS). Numbers from 0 to 10 on VAS; Patients will be asked to score their pain levels at rest, activity and at night, with 0 being defined as "no pain" and 10 being "unbearable pain". Increased scores indicate higher pain intensity.	10th week
Shoulder joint range of motion (ROM)	Joint range of motion will be measured and recorded passively in all directions using a goniometer according to the neutral zero method.	Baseline
Shoulder joint range of motion (ROM)	Joint range of motion will be measured and recorded passively in all directions using a goniometer according to the neutral zero method.	6th week
Shoulder joint range of motion (ROM)	Joint range of motion will be measured and recorded passively in all directions using a goniometer according to the neutral zero method.	10 th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index (SPADİ)	SPADI is a scale consisting of a total of 13 questions with 2 subscales: pain and disability. The score of the total and all sub-parameters is evaluated on a scale of 0-100. A high score indicates increased pain and impaired shoulder function.	Baseline
Shoulder Pain and Disability Index (SPADİ)	SPADI is a scale consisting of a total of 13 questions with 2 subscales: pain and disability. The score of the total and all sub-parameters is evaluated on a scale of 0-100. A high score indicates increased pain and impaired shoulder function.	6th week
Shoulder Pain and Disability Index (SPADİ)	SPADI is a scale consisting of a total of 13 questions with 2 subscales: pain and disability. The score of the total and all sub-parameters is evaluated on a scale of 0-100. A high score indicates increased pain and impaired shoulder function.	10th week
Modified Constant-Murley Scoring	Modified Constant-Murley Scoring includes a total of four parameters: pain, activities of daily living (ADL), active ROM and strength. The total score is evaluated on a scale of 0-100 points by summing all subparametricS. A low score reflects increased pain and impaired shoulder functions, both in terms of subparametrics and the total score.	6th week
Modified Constant-Murley Scoring	Modified Constant-Murley Scoring includes a total of four parameters: pain, activities of daily living (ADL), active ROM and strength. The total score is evaluated on a scale of 0-100 points by summing all subparametricS. A low score reflects increased pain and impaired shoulder functions, both in terms of subparametrics and the total score.	10th week
Modified Constant-Murley Scoring	Modified Constant-Murley Scoring includes a total of four parameters: pain, activities of daily living (ADL), active ROM and strength. The total score is evaluated on a scale of 0-100 points by summing all subparametricS. A low score reflects increased pain and impaired shoulder functions, both in terms of subparametrics and the total score.	Baseline

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi
• Investigators: Principal Investigator: Basak Cigdem Karacay, Asst Prof, Kirsehir Ahi Evran University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: pain; rehabilitation; nerve block; Rotator Cuff Tears
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2023-18/128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No