NCT07428512

Brief Summary

Chronic shoulder pain is a condition that typically lasts longer than three months and affects daily life. Among musculoskeletal system pathologies, shoulder pain ranks third after spine and knee pathologies. Patients with chronic shoulder pain often experience significant functional loss and reduced psychosocial well-being. Chronic shoulder pain may originate from instability, rotator cuff pathologies (calcific tendinitis, tendinopathy, full-thickness or partial tears), the acromioclavicular joint, adhesive capsulitis, or the glenohumeral joint. It results in pain, decreased joint range of motion, stiffness, limitations in activities of daily living, and ultimately disability. Musculoskeletal disorders constitute a significant health problem in the aging global population. Treatment options include patient education, lifestyle modifications, exercise, physical therapy modalities, medical treatments, intra-articular injections, periarticular injections, and suprascapular nerve block. The suprascapular nerve is a large peripheral nerve containing both motor and sensory fibers. It originates from the ventral rami of the C5 and C6 cervical nerve roots and may occasionally receive contributions from the C4 nerve root. The nerve arises from the lateral aspect of the upper trunk of the brachial plexus, passes beneath the omohyoid and trapezius muscles, and reaches the supraspinous fossa by passing under the suprascapular notch. The suprascapular nerve gives motor branches to the supraspinatus muscle and sensory branches to the acromioclavicular joint, coracoclavicular ligament, and the posterior part of the subacromial bursa. Compared with intra-articular injections, suprascapular nerve block has been shown to provide faster and greater effectiveness. This increases patient adherence to exercise, facilitates a quicker return to activities of daily living, and helps prevent further chronicity of the condition. A 5% dextrose solution is frequently used for perineural injections and has an osmolality similar to normal saline. Although its neural mechanism is not fully understood, it is thought to inhibit vanilloid receptor activation and block the release of substance P and calcitonin gene-related peptide (CGRP). Hypertonic dextrose (\>10%) may trigger local inflammation and promote tissue regeneration and symptom relief, while also increasing fibroblast proliferation and stimulating collagen synthesis and tissue healing. The primary aim of our study is to investigate and compare the effects of 5% and 10% dextrose injections around the suprascapular nerve on pain, joint range of motion, functionality, and kinesiophobia, and to determine their relative superiority. The secondary aim is to evaluate the effects of these injection treatments on supraspinatus muscle and tendon thickness, as well as quality of life, in association with improved adherence to exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 19, 2026

Last Update Submit

February 19, 2026

Conditions

Keywords

pain10% dextrose5% dextrosePerineural injection

Outcome Measures

Primary Outcomes (4)

  • Visual Analog Scale

    Patients indicate their pain on a 100 mm line, where 0 represents "no pain" and 100 represents "unbearable pain." The distance from 0 to the patient's mark reflects pain severity.

    baseline,after 1 month and 3 months changes

  • Shoulder Range of Motion (ROM)

    Clinician-assessed using a standard goniometer. Passive flexion, abduction, internal rotation, and external rotation of the affected shoulder will be measured.

    baseline,after 1 month and 3 months changes

  • Shoulder Pain and Disability Index (SPADI)

    Includes two subscales: pain (5 items) and disability (8 items). Responses are scored from 0-10. Subscale scores are calculated as a percentage of the maximum possible score, with higher scores indicating increased pain and reduced shoulder function.

    baseline,after 1 month and 3 months changes

  • Kinesiophobia

    Assessed using the Tampa Scale of Kinesiophobia (17 items, 4-point Likert scale, total score 17-68). Higher scores indicate higher fear of movement.

    baseline,after 1 month and 3 months changes

Secondary Outcomes (2)

  • Short Form-12 (SF-12) questionnaire

    baseline,after 1 month and 3 months changes

  • Supraspinatus Muscle and Tendon Thickness

    baseline,after 1 month and 3 months changes

Study Arms (2)

10% dextrose

ACTIVE COMPARATOR
Drug: dextrose

5% dextrose

ACTIVE COMPARATOR
Drug: dextrose

Interventions

Participants will receive ultrasound-guided perineural injections around the suprascapular nerve using either 5% or 10% dextrose solution. The injections aim to reduce pain, improve joint range of motion, enhance shoulder functionality, decrease kinesiophobia, and promote adherence to prescribed exercise programs. The 5% dextrose solution is isotonic, while the 10% dextrose solution is hypertonic and may additionally stimulate local tissue regeneration and collagen synthesis. Treatments will be administered under sterile conditions by an experienced clinician, and participants will be monitored for immediate and long-term effects on pain, muscle/tendon thickness, functional outcomes, and quality of life.

10% dextrose5% dextrose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years old with shoulder pain for the past 6 months who have not responded to medical treatment, exercise, corticosteroid injections, or physical therapy modalities, and who are willing to participate in the study.

You may not qualify if:

  • Patients younger than 18 or older than 75 years
  • Patients with a history of surgery on the same shoulder
  • Patients with neurological and/or inflammatory diseases
  • Patients with serious systemic diseases such as malignancy, end-stage congestive heart failure, or uncontrolled diabetes
  • Patients with insufficient cognitive function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Glucose

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 23, 2026

Study Start

July 9, 2025

Primary Completion

December 15, 2025

Study Completion

February 15, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations