Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272786
• Other study ID #: 2023-18/128
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Kirsehir Ahi Evran Universitesi
• Contact: Basak Cigdem Karacay, Asst Prof
• Phone: +9 0386 280 51 00.
• Email: basakcigdem[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nerve Block
• Pain
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Ahi Evran University	Kirsehir	City Centre

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Shoulder Pain and Disability Index (SPADI)	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
Secondary	Shoulder Pain and Disability Index (SPADI)	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
Secondary	Shoulder Pain and Disability Index (SPADI)	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
Secondary	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 sub-parameters. A low score reflects increased pain and impaired shoulder functions, both in terms of subparameters and the total score.	6th week
Secondary	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 sub-parameters. A low score reflects increased pain and impaired shoulder functions, both in terms of subparameters and the total score.	10th week
Secondary	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 sub-parameters. A low score reflects increased pain and impaired shoulder functions, both in terms of subparameters and the total score.	Baseline