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Hemiplegic Shoulder PainNCT06613646

The Importance of Pectoralis Minor Syndrome in Hemiplegic Shoulder Pain

A study testing Ultrasound-guided injection of the subacromial bursa and pectoralis minor and Lidocaine (drug) in people with Hemiplegic Shoulder Pain and Pectoralis Minor Syndrome, run by Istanbul University - Cerrahpasa 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

Hemiplegic shoulder pain, common in stroke patients, often arises from muscle weakness, imbalance, or joint and nerve issues. Previous case reports in literature suggest that pectoralis minor syndrome may play a significant role in this pain. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ultrasound-guided injection of the subacromial bursa and pectoralis minor and Lidocaine (drug)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2025to 1 Oct 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Development of spastic hemiplegia due to stroke
  • Presence of shoulder pain on the hemiplegic side

Who cannot join

  • Lack of medical stability
  • Inability to communicate verbally
  • History of severe sensitivity to lidocaine injections
  • Surgical history related to the hemiplegic shoulder
  • Presence of a prosthesis in the hemiplegic shoulder
  • Malignancy in the hemiplegic shoulder
Show all 10Show fewer
  • Severe psychiatric illness
  • History of injections to the hemiplegic shoulder within the last 6 months
  • Pregnancy
  • History of inflammatory rheumatic disease

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University - Cerrahpasa (IUC)

    Istanbul, 34098

Other trials in Turkey (Türkiye)

About this study

Official title: The Importance of Pectoralis Minor Syndrome in Hemiplegic Shoulder Pain: A Prospective, Interventional Study

Hemiplegic shoulder pain, common in stroke patients, often arises from muscle weakness, imbalance, or joint and nerve issues. Previous case reports in literature suggest that pectoralis minor syndrome may play a significant role in this pain. In current study, the investigators aimed to evaluate the role of the pectoralis minor muscle in patients with hemiplegic shoulder pain and to reveal the contribution of pectoralis minor syndrome to hemiplegic shoulder pain. Additionally, this study may provide fundamental information to improve clinical practice in determining rehabilitation and treatment strategies, contribute to the development of new approaches in managing hemiplegic shoulder pain, and assist in optimizing rehabilitation programs.

Read the detailed description

Hemiplegic shoulder pain is a common complication following a stroke, with a prevalence ranging from 22% to 47%, typically occurring two to three months post-stroke. This pain can lead to withdrawal from rehabilitation programs, longer hospital stays, reduced joint mobility, and impaired quality of life. Various factors contribute to its development, including decreased muscle tone, shoulder subluxation, increased muscle tone, impingement syndrome, frozen shoulder, brachial plexus injury, and thalamic syndrome. Among these, subacromial/subdeltoid bursitis is the most frequently reported cause of pain, and significant pain relief following local anesthetic injections into the subacromial/subdeltoid bursa is diagnostic of subacromial impingement syndrome.

Treatment goals for hemiplegic shoulder pain include pain reduction, restoring shoulder mobility, improving functional activities, and preventing degenerative changes. Treatment options range from conservative methods like shoulder slings, range-of-motion exercises, pain relievers, physical therapy, and various injection therapies, to surgical interventions for cases unresponsive to conservative measures.

Pectoralis minor syndrome, associated with hemiplegic shoulder pain, can occur in stroke patients. The pectoralis minor muscle plays a crucial role in shoulder stability and movement. Compression or irritation of neurovascular structures in the retropectoral space by this muscle leads to pectoralis minor syndrome, often diagnosed through clinical evaluation rather than specific radiological or electrophysiological tests. Ultrasound-guided pectoralis minor muscle blocks have become significant in both diagnosis and treatment, demonstrating marked pain reduction in affected patients. Research on pectoralis minor syndrome aims to enhance understanding of its causes, effects, and treatment strategies, contributing to the development of more effective and specific approaches for managing hemiplegic shoulder pain.

Being tested
Ultrasound-guided injection of the subacromial bursa and pectoralis minor, Lidocaine (drug)
Keywords
Pectoralis Minor Syndrome, Ultrasound Guided Injections, Hemiplegia, Hemiplegic Shoulder Pain
Medical subject headings
Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-guided injection of the subacromial bursa and pectoralis minorProcedure or surgery

    Patients will first receive an ultrasound-guided injection of the subacromial bursa. After the subacromial bursa injection, patients will be monitored for 1 hour, after which the level of relief in their complaints will be assessed using the Numeric Rating Scale (NRS), and passive range of motion will be measured.

    Following the subacromial bursa injection, patients will receive an ultrasound-guided injection of the pectoralis minor muscle. After the pectoralis minor muscle injection, patients will again be monitored for 1 hour, after which the level of relief in their complaints will be assessed using the NRS, and passive range of motion will be measured.

  • Lidocaine (drug)Drug

    5 mL of 2% lidocaine will be used as a local anesthetic for the subacromial bursa injection, and 4 mL of 2% lidocaine will be used for the pectoralis minor muscle injection.

Study groups in NCT06613646
Study groupRoleWhat they receive
Intervention ArmExperimentalPatients presenting to the outpatient clinic with shoulder pain on the hemiplegic side will first undergo a diagnostic subacromial bursa injection, followed by a pectoralis minor muscle block.
Receives: Procedure: Ultrasound-guided injection of the subacromial bursa and pectoralis minor; Drug: Lidocaine (drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Relief

    Pain will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain imaginable), at rest, during movement, at night, and overall, both before and after injections into the subacromial bursa and the pectoralis minor muscle. Higher scores indicate worse pain outcomes.

    Measured: Baseline, one hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, and one month

  2. Passive Range of Motion of Shoulder

    Passive shoulder flexion, abduction, and external rotation will be measured with a goniometer. Flexion and abduction will be measured from 0° (no range of motion) to 180° (full range of motion), while external rotation will be measured from 0° to 90°. Higher scores indicate better outcomes in terms of range of motion.

    Measured: Baseline, one hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, and one month

Secondary outcomes (5)
  1. Modified Ashworth Scale

    Spasticity in upper extremity muscles will be assessed using the Modified Ashworth Scale (MAS), which ranges from 0 to 4. A score of 0 indicates no increase in muscle tone, while a score of 4 indicates the affected part is rigid in flexion or extension. Higher scores on the MAS indicate worse spasticity outcomes.

    Measured: Baseline

  2. Brunnstrom Stages of Recovery for Upper Extremity Motor Function and Hand Function

    Upper extremity motor function and hand function will be assessed using the Brunnstrom Stages of Recovery. This scale ranges from Stage 1 (flaccidity, no voluntary movement) to Stage 6 (normal motor function). For both upper extremity motor function and hand function, higher scores indicate better recovery and motor outcomes.

    Measured: Baseline

  3. Functional Ambulation Scale

    Ambulation will be assessed using the Functional Ambulation Scale, which ranges from 0 to 5. A score of 0 indicates the inability to walk or requiring maximal assistance, while a score of 5 indicates independent ambulation on all surfaces without assistance. Higher scores indicate better ambulation outcomes.

    Measured: Baseline

  4. Subluxation in the glenohumeral joint

    It will be assessed by placing the ultrasound probe along the long axis of the humerus over the lateral edge of the acromion. The distance is defined as the relative lateral distance between the lateral edge of the acromion and the nearest edge of the superior part of the greater tuberosity of the humerus. A difference greater than 0.4 cm indicates the presence of subluxation.

    Measured: Baseline

  5. Overall Improvement

    Overall improvement will be assessed as a self-reported percentage, ranging from 0% (no improvement) to 100% (complete improvement). Higher percentages indicate better outcomes, with 100% representing full recovery as perceived by the patient.

    Measured: One hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start1 May 2025
  3. Primary completion1 Oct 2025
  4. Study completion1 Oct 2025

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06613646
Sponsor's protocol ID
IstanbulUC-BCetin-01
Status last verified
Nov 2025
First submitted
12 Sep 2024
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.

    PubMed 6825348
  • Aktas I, Kaya E, Akpinar P, Atici A, Unlu Ozkan F, Palamar D, Akgun K. Spasticity-induced Pectoralis minor syndrome: a case-report. Top Stroke Rehabil. 2020 May;27(4):316-319. doi: 10.1080/10749357.2019.1691807. Epub 2019 Nov 27.

    PubMed 31774031
  • Lin PH. Sonographic findings of painful hemiplegic shoulder after stroke. J Chin Med Assoc. 2018 Jul;81(7):657-661. doi: 10.1016/j.jcma.2017.07.018. Epub 2017 Dec 6.

    PubMed 29217360
  • Sanders RJ, Annest SJ. Thoracic outlet and pectoralis minor syndromes. Semin Vasc Surg. 2014 Jun;27(2):86-117. doi: 10.1053/j.semvascsurg.2015.02.001. Epub 2015 Feb 18.

    PubMed 25868762
  • Lee KW, Choi YJ, Lee HJ, Gil YC, Kim HJ, Tansatit T, Hu KS. Classification of unusual insertion of the pectoralis minor muscle. Surg Radiol Anat. 2018 Dec;40(12):1357-1361. doi: 10.1007/s00276-018-2107-0. Epub 2018 Oct 10.

    PubMed 30306210
  • Murie-Fernandez M, Carmona Iragui M, Gnanakumar V, Meyer M, Foley N, Teasell R. [Painful hemiplegic shoulder in stroke patients: causes and management]. Neurologia. 2012 May;27(4):234-44. doi: 10.1016/j.nrl.2011.02.010. Epub 2011 Apr 22. Spanish.

    PubMed 21514698
  • Adey-Wakeling Z, Arima H, Crotty M, Leyden J, Kleinig T, Anderson CS, Newbury J; SEARCH Study Collaborative. Incidence and associations of hemiplegic shoulder pain poststroke: prospective population-based study. Arch Phys Med Rehabil. 2015 Feb;96(2):241-247.e1. doi: 10.1016/j.apmr.2014.09.007. Epub 2014 Sep 28.

    PubMed 25264111
  • Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.

    PubMed 17185637
  • Griffin JW. Hemiplegic shoulder pain. Phys Ther. 1986 Dec;66(12):1884-93. doi: 10.1093/ptj/66.12.1884.

    PubMed 2431421
  • Bender L, McKenna K. Hemiplegic shoulder pain: defining the problem and its management. Disabil Rehabil. 2001 Nov 10;23(16):698-705. doi: 10.1080/09638280110062149.

    PubMed 11732559

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-guided injection of the subacromial bursa and pectoralis minor and Lidocaine (drug) in people with Hemiplegic Shoulder Pain and Pectoralis Minor Syndrome, run by Istanbul University - Cerrahpasa 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 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: finished, as of the sponsor's last update on 19 Nov 2025. 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?

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 Relief (time frame: Baseline, one hour after subacromial bursa injection, one hour after pectoralis minor injection, one week, and one month). The study lists 2 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 NCT06613646, which also lists 10 linked publications.

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 19 Nov 2025.

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