Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair

NCT06272786 | Recruiting

• 1 other identifier: 2023-18/128
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tears; Pain; Nerve Block

Keywords

Rotator Cuff Tears; pain; nerve block; rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Shoulder Pain and Disability Index (SPADİ)

  Baseline

• Shoulder Pain and Disability Index (SPADİ)

  6th week

• Shoulder Pain and Disability Index (SPADİ)

  10th week

• Modified Constant-Murley Scoring

  6th week

• Modified Constant-Murley Scoring

  10th week

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.; Procedure: Suprascapular nerve block

Control Group

ACTIVE COMPARATOR

Patients in the control group will only receive a conventional physiotherapy program.

Procedure: conventional physiotherapy program.

Interventions

conventional physiotherapy program. PROCEDURE

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.

Control Group; Experimental Group

Suprascapular nerve block PROCEDURE

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ahi Evran University

Kirşehir, City Centre, 40100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Basak Cigdem Karacay, Asst Prof

  Kirsehir Ahi Evran University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basak Cigdem Karacay, Asst Prof

CONTACT

+9 0386 280 51 00.; basakcigdem@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcome assessor will be different persons.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 22, 2024
• Study Start: July 28, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)