Pericapsular Nerve Group Block (PENG Block)Phase 4NCT06699693
Effectiveness of Ultrasonography-guided Pericapsular Nerve Group Block in Patients With Adhesive Capsulitis
A Phase 4 study testing ultrasonography-guided PENG block and Mobilization in people with Pericapsular Nerve Group Block (PENG Block) and Kinesiophobia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to observe the effects of Ultrasound-Guided Pericapsular Nerve Group Block administered before joint mobilization therapy on shoulder pain levels, function, and kinesiophobia in patients with resistant Adhesive Capsulitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pericapsular Nerve Group Block (PENG Block), Kinesiophobia, Adhesive Capsulitis and Frozen Shoulder Syndrome
- What is being tested?
- ultrasonography-guided PENG block and Mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 29 Sep 2024
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder pain (Visual Analog Scale, VAS: 50 mm or more) and limitation of movement (at least 50% loss in active and passive ROM on the affected side) for at least 3 months
- Poor response to previous exercise and drug therapy
Who cannot join
- Severe systemic illnesses such as neurological diseases (e.g., Parkinson's disease, previous cerebrovascular disease, dementia), psychiatric disorders (e.g., major depression), diabetes mellitus, malignancy, infection, rheumatologic diseases (e.g., systemic lupus erythematosus), neuromuscular diseases (e.g., motor neuron diseases)
- History of major orthopedic surgery, such as total shoulder replacement
- History of steroid injection into the shoulder within the last 3 months
- Previous mobilization therapy on the affected shoulder
- Advanced-stage heart, liver, or kidney failure
- High risk of bleeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medical Faculty, Ondokuz Mayis University, Samsun, Turkey
Samsun, 55105
About this study
Official title: Effectiveness of Ultrasonography-guided Pericapsular Nerve Group Block in Patients With Adhesive Capsulitis Resistant to Conservative Treatment
We aimed to observe the effects of Ultrasound-Guided Pericapsular Nerve Group Block administered before joint mobilization therapy on shoulder pain levels, function, and kinesiophobia in patients with resistant Adhesive Capsulitis.
Voluntary patients who applied to the Physical Therapy and Algology Department, did not benefit from physical therapy, and were recommended injection and mobilization therapy will be included in the study. Patients who decline injection but consent to mobilization therapy will be included as the control group. Those who accept the injection will be treated as Group 1 (Block + mobilization therapy), and those who decline the injection will be treated as Group 2 (mobilization therapy only).
Read more
Group 1 patients will receive a pericapsular nerve block before mobilization therapy, and a one-hour observation period will follow to assess the effectiveness of the procedure and monitor the patient. Patients will be evaluated for pain and range of motion (ROM) before and after the injection. Subsequently, they will undergo mobilization therapy three times a week for six weeks. Group 2 will follow the same program but will only receive mobilization therapy.
The following demographic data will be collected from the patients included in the study: age, gender, height, weight, education level, occupation, employment status, history of alcohol and smoking, comorbidities, current medications, dominant hand, and exercise status.
Patients' medical histories will be reviewed, and any prior test results (e.g., blood glucose, thyroid dysfunction, lipid levels, vitamin D, and vitamin B12 levels) will be recorded. Findings from previous diagnostic or differential diagnostic imaging for shoulder pain (shoulder X-rays, ultrasound, or MRI) as well as routine biochemistry blood test results will be evaluated and documented. Comprehensive physical examinations, including systemic and neurological assessments, ROM measurements, and muscle strength evaluations, will also be conducted.
- DASH Score (Disabilities of the Arm, Shoulder, and Hand Questionnaire): This questionnaire consists of three sections. Among the 30 questions, 21 assess difficulty in daily living activities, 5 address pain, activity-related pain, tingling, stiffness, and weakness, while 4 evaluate social function, work, sleep, and self-confidence. All questions are rated on a 5-point Likert scale, where 5 indicates extreme difficulty. Higher scores reflect greater disability.
- Modified Constant-Murley Score: This score evaluates four parameters with a total of 100 points. Pain is allocated 15 points, daily living activities 20 points, muscle strength 25 points, and shoulder ROM (elevation, external rotation, abduction, internal rotation) 40 points. Higher scores indicate better function.
- VAS (Visual Analog Scale) for Pain: Pain is scored as rest VAS, movement-related VAS, and night pain VAS on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain.
- Tampa Scale of Kinesiophobia: A 17-item scale developed to measure fear of movement and re-injury. It includes parameters such as work-related activities, fear of injury/re-injury, and fear-avoidance behavior.
- Shoulder Range of Motion (ROM): Measured in degrees using a goniometer and recorded.
- Complications and Side Effects: These will be inquired from the patient and recorded.
- Ultrasound-Guided Pericapsular Nerve Group Block: This procedure will be performed in an outpatient clinic setting and applied only once to Group 1.
During the procedure, with the patient's arm in an externally rotated and 45-degree abducted position, a linear ultrasound probe will be placed longitudinally between the coracoid process and the humeral head. After identifying the humeral head, the subscapularis muscle tendon and the overlying deltoid muscle will be visualized. A 50 mm needle will be advanced using an in-plane technique into the area between the deltoid muscle and subscapularis tendon. A total of 20 cc of a solution containing 0.25% bupivacaine hydrochloride and 6 mg of betamethasone (Celestone Chronodose) will be injected.
- Conditions
- Pericapsular Nerve Group Block (PENG Block), Kinesiophobia, Adhesive Capsulitis and Frozen Shoulder Syndrome
- Being tested
- ultrasonography-guided PENG block, Mobilization
- Keywords
- Adhesive capsulitis, Pericapsular Nerve Group Block, pain, function, kinesiophobia
- Medical subject headings
- Kinesiophobia, Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography-guided PENG blockProcedure or surgery
This study aimed to evaluate the effect of ultrasonography-guided PENG block prior to joint mobilization therapy on shoulder pain, function, and kinesiophobia in patients with AC resistant to conservative treatment, in comparison with a control group
MobilizationOther
The mobilization methods encompassed the scapula and clavicular joints, in addition to the glenohumeral (GH) joint, taking into consideration their biomechanical interactions. These exercises were supervised and administered by the physiotherapist during each session. Additionally, the patients were provided with a home exercise program that included exercises for posture, thera band, and finger ladder, with instructions to perform 10-15 repetitions twice a day independently [
| Study group | Role | What they receive |
|---|---|---|
| Group1 Injection+Mobilization | Active comparator | Group 1 patients underwent ultrasound-guided PENG block (20 cc of a solution containing 0.25% bupivacaine hydrochloride and 6 mg betamethasone) by an experienced algologist (BU) before starting mobilization treatment Receives: Procedure: ultrasonography-guided PENG block |
| Group 2 Mobilization | Active comparator | only mobilization therapy on shoulder pain, function, and kinesiophobia in patients with AC resistant to conservative treatment, Receives: Other: Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Resting pain, pain during activity, and night pain were assessed using VAS, where 0 indicated no pain and 10 represented the highest pain level
Measured: for 6 weeks
Shoulder Joint Range of Motion (ROM)
Active and passive shoulder flexion, abduction, internal rotation, and external rotation were measured with the patient lying supine, using a goniometer
Measured: for 6 weeks
Function
Disabilities of Arm, Shoulder and Hand (DASH)
This questionnaire consists of 3 parts. Twenty-one of the 30 questions are about difficulty in activities of daily living, 5 questions are about pain, activity-related pain, tingling, stiffness and weakness, and 4 questions are about social function, work, sleep and self-confidence. All questions are rated on a Likert scale of 5, where 5 indicate too much difficulty. A high score indicates limitation. Turkish validity and reliability were examined
Measured: for 6 weeks
Function
Modified Constant-Murley Score (MCMS) The four parameters are evaluated with a total of 100 points. Pain is calculated as 15 points, activities of daily living 20 points, muscle strength 25 points, and shoulder ROM (elevation, ER, Abd, IR) 40 points and high scores indicate good function. Turkish validity and reliability were investigated
Measured: for 6 weeks
Muscle strength
Muscle strength was measured using a portable hand dynamometer
Measured: for 6 weeks
Kinesiophobia
The Tampa Scale of Kinesiophobia (TSK): The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. The Turkish version was validated and is reliable
Measured: for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Jun 2024
- Primary completion30 Aug 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pericapsular Nerve Group Block (PENG Block)Studies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Uzuner, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699693
- Sponsor's protocol ID
- (No:223/2024)
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
PubMed 34118263
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasonography-guided Pericapsular Nerve Group Block in Patients With Adhesive Capsulitis Resistant to Conservative Treatment
- ClinicalTrials.gov ID
- NCT06699693
- Acronym / sponsor ID
- (No:223/2024)
- Conditions
- Pericapsular Nerve Group Block (PENG Block), Kinesiophobia, Adhesive Capsulitis and Frozen Shoulder Syndrome
- Keywords
- Adhesive capsulitis, Pericapsular Nerve Group Block, pain, function, kinesiophobia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 21 Nov 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.
We aimed to observe the effects of Ultrasound-Guided Pericapsular Nerve Group Block administered before joint mobilization therapy on shoulder pain levels, function, and kinesiophobia in patients with resistant Adhesive Capsulitis.
Voluntary patients who applied to the Physical Therapy and Algology Department, did not benefit from physical therapy, and were recommended injection and mobilization therapy will be included in the study. Patients who decline injection but consent to mobilization therapy will be included as the control group. Those who accept the injection will be treated as Group 1 (Block + mobilization therapy), and those who decline the injection will be treated as Group 2 (mobilization therapy only).
Group 1 patients will receive a pericapsular nerve block before mobilization therapy, and a one-hour observation period will follow to assess the effectiveness of the procedure and monitor the patient. Patients will be evaluated for pain and range of motion (ROM) before and after the injection. Subsequently, they will undergo mobilization therapy three times a week for six weeks. Group 2 will follow the same program but will only receive mobilization therapy.
The following demographic data will be collected from the patients included in the study: age, gender, height, weight, education level, occupation, employment status, history of alcohol and smoking, comorbidities, current medications, dominant hand, and exercise status.
Patients' medical histories will be reviewed, and any prior test results (e.g., blood glucose, thyroid dysfunction, lipid levels, vitamin D, and vitamin B12 levels) will be recorded. Findings from previous diagnostic or differential diagnostic imaging for shoulder pain (shoulder X-rays, ultrasound, or MRI) as well as routine biochemistry blood test results will be evaluated and documented. Comprehensive physical examinations, including systemic and neurological assessments, ROM measurements, and muscle strength evaluations, will also be conducted.
- DASH Score (Disabilities of the Arm, Shoulder, and Hand Questionnaire): This questionnaire consists of three sections. Among the 30 questions, 21 assess difficulty in daily living activities, 5 address pain, activity-related pain, tingling, stiffness, and weakness, while 4 evaluate social function, work, sleep, and self-confidence. All questions are rated on a 5-point Likert scale, where 5 indicates extreme difficulty. Higher scores reflect greater disability.
- Modified Constant-Murley Score: This score evaluates four parameters with a total of 100 points. Pain is allocated 15 points, daily living activities 20 points, muscle strength 25 points, and shoulder ROM (elevation, external rotation, abduction, internal rotation) 40 points. Higher scores indicate better function.
- VAS (Visual Analog Scale) for Pain: Pain is scored as rest VAS, movement-related VAS, and night pain VAS on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain.
- Tampa Scale of Kinesiophobia: A 17-item scale developed to measure fear of movement and re-injury. It includes parameters such as work-related activities, fear of injury/re-injury, and fear-avoidance behavior.
- Shoulder Range of Motion (ROM): Measured in degrees using a goniometer and recorded.
- Complications and Side Effects: These will be inquired from the patient and recorded.
- Ultrasound-Guided Pericapsular Nerve Group Block: This procedure will be performed in an outpatient clinic setting and applied only once to Group 1.
During the procedure, with the patient's arm in an externally rotated and 45-degree abducted position, a linear ultrasound probe will be placed longitudinally between the coracoid process and the humeral head. After identifying the humeral head, the subscapularis muscle tendon and the overlying deltoid muscle will be visualized. A 50 mm needle will be advanced using an in-plane technique into the area between the deltoid muscle and subscapularis tendon. A total of 20 cc of a solution containing 0.25% bupivacaine hydrochloride and 6 mg of betamethasone (Celestone Chronodose) will be injected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 Injection+Mobilization | Active comparator | Procedure: ultrasonography-guided PENG blockGroup 1 patients underwent ultrasound-guided PENG block (20 cc of a solution containing 0.25% bupivacaine hydrochloride and 6 mg betamethasone) by an experienced algologist (BU) before starting mobilization treatment |
| Group 2 Mobilization | Active comparator | Other: Mobilizationonly mobilization therapy on shoulder pain, function, and kinesiophobia in patients with AC resistant to conservative treatment, |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Shoulder pain (Visual Analog Scale, VAS: 50 mm or more) and limitation of movement (at least 50% loss in active and passive ROM on the affected side) for at least 3 months
- Poor response to previous exercise and drug therapy
Key exclusion criteria (6 listed)
- Severe systemic illnesses such as neurological diseases (e.g., Parkinson's disease, previous cerebrovascular disease, dementia), psychiatric disorders (e.g., major depression), diabetes mellitus, malignancy, infection, rheumatologic diseases (e.g., systemic lupus erythematosus), neuromuscular diseases (e.g., motor neuron diseases)
- History of major orthopedic surgery, such as total shoulder replacement
- History of steroid injection into the shoulder within the last 3 months
- Previous mobilization therapy on the affected shoulder
- Advanced-stage heart, liver, or kidney failure
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 |
|---|---|---|
| ultrasonography-guided PENG blockThis study aimed to evaluate the effect of ultrasonography-guided PENG block prior to joint mobilization therapy on shoulder pain, function, and kinesiophobia in patients with AC resistant to conservative treatment, in comparison with a control group | Procedure or surgery | Group1 Injection+Mobilization |
| MobilizationThe mobilization methods encompassed the scapula and clavicular joints, in addition to the glenohumeral (GH) joint, taking into consideration their biomechanical interactions. These exercises were supervised and administered by the physiotherapist during each session. Additionally, the patients were provided with a home exercise program that included exercises for posture, thera band, and finger ladder, with instructions to perform 10-15 repetitions twice a day independently [ | Other | Group 2 Mobilization |
Primary outcome
Pain
Time frame: for 6 weeks
Resting pain, pain during activity, and night pain were assessed using VAS, where 0 indicated no pain and 10 represented the highest pain level
Shoulder Joint Range of Motion (ROM)
Time frame: for 6 weeks
Active and passive shoulder flexion, abduction, internal rotation, and external rotation were measured with the patient lying supine, using a goniometer
Function
Time frame: for 6 weeks
Disabilities of Arm, Shoulder and Hand (DASH) This questionnaire consists of 3 parts. Twenty-one of the 30 questions are about difficulty in activities of daily living, 5 questions are about pain, activity-related pain, tingling, stiffness and weakness, and 4 questions are about social function, work, sleep and self-confidence. All questions are rated on a Likert scale of 5, where 5 indicate too much difficulty. A high score indicates limitation. Turkish validity and reliability were examined
Function
Time frame: for 6 weeks
Modified Constant-Murley Score (MCMS) The four parameters are evaluated with a total of 100 points. Pain is calculated as 15 points, activities of daily living 20 points, muscle strength 25 points, and shoulder ROM (elevation, ER, Abd, IR) 40 points and high scores indicate good function. Turkish validity and reliability were investigated
Muscle strength
Time frame: for 6 weeks
Muscle strength was measured using a portable hand dynamometer
Kinesiophobia
Time frame: for 6 weeks
The Tampa Scale of Kinesiophobia (TSK): The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. The Turkish version was validated and is reliable
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Results publication: PubMed 34118263Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ultrasonography-guided PENG block and Mobilization in people with Pericapsular Nerve Group Block (PENG Block) and Kinesiophobia, run by Ondokuz Mayıs University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 21 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: for 6 weeks). 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?
On the ClinicalTrials.gov record for NCT06699693, which also lists 1 linked publication.
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 21 Nov 2024.