Rotator Cuff TearsNCT06272786
Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair
A study testing conventional physiotherapy program. and Suprascapular nerve block in people with Rotator Cuff Tears and Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tears, Pain, Nerve Block
- What is being tested?
- conventional physiotherapy program. and Suprascapular nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Having undergone arthroscopic rotator cuff repair surgery within the last week
Who cannot join
- 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
Show all 10Show fewer
- Fibromyalgia syndrome
- Chronic painful conditions that require opioid use
- Presence of known psychiatric disease
- Cognitive impairment (Mini Mental Test Score <23)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ahi Evran University
Kirşehir, City Centre, 40100
Basak Cigdem Karacay, Assist Prof, :+90 386 280 39 00, basak.cigdemkaracay@ahivran.edu.tr
Basak Cigdem Karacay, Assist Prof
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tears, Pain, Nerve Block
- Being tested
- conventional physiotherapy program., Suprascapular nerve block
- Keywords
- Rotator Cuff Tears, pain, nerve block, rehabilitation
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physiotherapy program.Procedure or surgery
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 blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: conventional physiotherapy program.; Procedure: Suprascapular nerve block |
| Control Group | Active comparator | Patients in the control group will only receive a conventional physiotherapy program. Receives: Procedure: conventional physiotherapy program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 th week
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start28 Jul 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Cigdem Karacay, Kirsehir Ahi Evran Universitesi
- Investigators
- Basak Cigdem Karacay, Asst Prof, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272786
- Sponsor's protocol ID
- 2023-18/128
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Suprascapular Nerve Block in Patients Rehabilitated After Arthroscopic Rotator Cuff Repair: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06272786
- Acronym / sponsor ID
- 2023-18/128
- Conditions
- Rotator Cuff Tears, Pain, Nerve Block
- Keywords
- Rotator Cuff Tears, pain, nerve block, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 28 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: conventional physiotherapy program., Procedure: Suprascapular nerve blockIn 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. |
| Control Group | Active comparator | Procedure: conventional physiotherapy program.Patients in the control group will only receive a conventional physiotherapy program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Having undergone arthroscopic rotator cuff repair surgery within the last week
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Control Group, Experimental Group |
| Suprascapular nerve blockBupivacaine 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 or surgery | Experimental Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline
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.
Visual Analog Scale (VAS)
Time frame: 6th week
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.
Visual Analog Scale (VAS)
Time frame: 10th week
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.
Shoulder joint range of motion (ROM)
Time frame: Baseline
Joint range of motion will be measured and recorded passively in all directions using a goniometer according to the neutral zero method.
Shoulder joint range of motion (ROM)
Time frame: 6th week
Joint range of motion will be measured and recorded passively in all directions using a goniometer according to the neutral zero method.
Shoulder joint range of motion (ROM)
Time frame: 10 th week
Joint range of motion will be measured and recorded passively in all directions using a goniometer according to the neutral zero method.
6 secondary outcomes
Shoulder Pain and Disability Index (SPADİ)
Time frame: Baseline
Shoulder Pain and Disability Index (SPADİ)
Time frame: 6th week
Shoulder Pain and Disability Index (SPADİ)
Time frame: 10th week
Modified Constant-Murley Scoring
Time frame: 6th week
Modified Constant-Murley Scoring
Time frame: 10th week
Modified Constant-Murley Scoring
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basak Cigdem Karacay, Asst Prof principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physiotherapy program. and Suprascapular nerve block in people with Rotator Cuff Tears and Pain, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basak Cigdem Karacay, Asst Prof (+9 0386 280 51 00., basakcigdem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.