NCT07346755

Brief Summary

The purpose of this prospective randomized controlled clinical trial is to evaluate the effect of suprascapular nerve block on shoulder joint proprioception in stroke patients with hemiplegic shoulder pain. Fourteen patients aged 18-80 years with hemiplegic shoulder pain will be randomized into two groups. One group will receive suprascapular nerve block followed by a standardized physical therapy program, while the control group will receive the same physical therapy program alone. The primary outcome is shoulder joint proprioception. Secondary outcomes include pain intensity, shoulder range of motion, motor recovery, stroke-specific quality of life, and upper extremity functional outcomes. The results of this study are expected to clarify the role of suprascapular nerve block on proprioception and rehabilitation outcomes in patients with hemiplegic shoulder pain.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 8, 2026

Last Update Submit

January 18, 2026

Conditions

Keywords

Hemiplegic Shoulder PainProprioceptionSuprascapular nerve blockHemiplegia

Outcome Measures

Primary Outcomes (2)

  • Laser pointer-assisted joint position sense test

    The validity and reliability of the laser pointer-assisted joint position sense test in patients with shoulder instability were established by Amir K. Vafadar et al., with inter-observer and intra-observer correlation coefficients of 0.78 and 0.86, respectively. In this test, a laser pointer is secured to the patient's arm using a Velcro strap positioned 5 cm proximal to the elbow. With eyes open, the patient is asked to raise the hemiplegic arm to 90 degrees. The laser point is marked on millimeter paper fixed 1 meter in front of the shoulder joint. The patient is then asked, with eyes open, to relocate the same point to learn the joint position. Subsequently, with eyes closed, the patient is asked to identify the same point again. This second point is marked, and the distance from the initial point is measured along the x- and y-axes. The angular deviation of the shoulder joint position is calculated using the tangent formula.

    This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)

  • Thumb localization test

    For the assessment of proprioception, the thumb localization test will be performed. The validity and reliability of this test in patients with hemiplegia were established by Otaka et al., with a weighted kappa value of 0.84 for inter-observer measurements, indicating high agreement. With the patient's eyes closed, the patient is asked to locate and grasp the thumb of the affected hand using the fingers of the unaffected hand

    This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)

Secondary Outcomes (7)

  • Numeric Rating Scale (NRS)

    This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)

  • Goniometric measurement

    This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)

  • Goal Attainment Scale (GAS)

    This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)

  • Fugl-Meyer Assessment - Upper Extremity

    This test will be assessed at baseline (T0). Follow-up assessments will be performed at 2 hours post-intervention (T1, intervention group only), at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)

  • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire

    This test will be assessed at baseline (T0). Follow-up assessments will be performed at the end of the 3-week rehabilitation program (T2), and at week 7 (T3)

  • +2 more secondary outcomes

Study Arms (2)

Suprascapular Nerve Block

EXPERIMENTAL

Participants in this arm will receive a suprascapular nerve block administered by an experienced physician, followed by a standardized physical therapy and rehabilitation program. The nerve block will be performed using local anesthetic to reduce shoulder pain and facilitate participation in rehabilitation.

Procedure: suprascapular nerve blockOther: physical therapy

Control

ACTIVE COMPARATOR

Participants in this arm will receive a standardized physical therapy and rehabilitation program alone, without suprascapular nerve block. The program will be identical to that provided to the experimental arm and will follow routine clinical practice for hemiplegic shoulder pain.

Other: physical therapy

Interventions

An ultrasound-guided suprascapular nerve block will be performed by injecting 5 mL of 2% lidocaine (Lidon 100 mg/5 mL solution for injection) into the suprascapular fossa.

Suprascapular Nerve Block

Accepted routine physical therapy modalities for hemiplegic shoulder pain, including cold pack application, transcutaneous electrical nerve stimulation, assisted shoulder range of motion exercises, and posterior capsule stretching exercises, will be administered five days per week for three weeks, in 45-minute sessions, for a total of 15 sessions

ControlSuprascapular Nerve Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years
  • Presence of shoulder pain on the hemiplegic side with a Numeric Rating Scale (NRS) score \> 3
  • At least 1 month since the cerebrovascular event (subacute and chronic stroke patients)
  • Active shoulder flexion range of motion \> 90 degrees (required for the application of the laser pointer-assisted joint position sense test)
  • First-ever, unilateral hemiplegia

You may not qualify if:

  • Mini-Mental State Examination score \< 24 indicating cognitive impairment
  • Presence of aphasia
  • Shoulder spasticity with a Modified Ashworth Scale score \> 2
  • Brunnstrom upper extremity motor stage \< 3
  • Botulinum toxin type A injection within the last 3 months to muscles affecting shoulder joint movement (trapezius, levator scapulae, pectoralis major, deltoid, serratus anterior, latissimus dorsi, rhomboids, teres major, biceps, coracobrachialis, triceps, supraspinatus, subscapularis, infraspinatus, and teres minor)
  • Pre-existing shoulder pathology causing pain in the hemiplegic shoulder
  • Presence of neglect syndrome
  • Complex regional pain syndrome, central pain, traumatic brachial plexus injury
  • Change in pain medication during the study period
  • Hypersensitivity to the medication used for suprascapular nerve block (lidocaine)
  • Adhesive capsulitis (frozen shoulder)
  • Other shoulder pathologies such as fractures or joint replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital Istanbul, İstanbul, Turkey

Istanbul, Istanbul, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Central Study Contacts

Esra Giray, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The study is planned as an investigators-blinded study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A controlled, investigator-blinded, prospective parallel-group study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

May 1, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations