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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06699693
Study groupRoleWhat they receive
Group1 Injection+MobilizationActive comparatorGroup 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 MobilizationActive comparatoronly 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. Muscle strength

    Muscle strength was measured using a portable hand dynamometer

    Measured: for 6 weeks

  6. 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.

  1. First posted21 Nov 2024
  2. Study start1 Jun 2024
  3. Primary completion30 Aug 2024
  4. Study completion29 Sep 2024

Resources

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)
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

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.

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