Proprioceptive Neuromuscular Facilitation vs Conventional Therapy With Ultrasound-Guided Corticosteroid Injections for Subacromial Bursitis

March 27, 2026 updated by: De Sire Alessandro, University of Catanzaro

Efficacy of a Proprioceptive Neuromuscular Facilitation Versus Conventional Physical Therapy, Combined With Ultrasound-guided Corticosteroids Injections, in Subacromial Bursitis: a Randomized Controlled Trial

This study aims to evaluate the effectiveness of a combined treatment approach for people with chronic shoulder pain caused by subacromial bursitis.

Subacromial bursitis is a common condition that can cause pain, stiffness, and reduced ability to move the shoulder. These symptoms often interfere with daily activities such as dressing, lifting objects, or reaching overhead, and may negatively affect quality of life.

In current clinical practice, corticosteroid injections are frequently used to reduce inflammation and relieve pain, especially in patients with persistent symptoms. Physiotherapy is also an essential part of treatment, helping to restore movement, strength, and function. However, it is not yet clear which type of rehabilitation program provides the best results when combined with injections.

In this study, all participants receive three ultrasound-guided corticosteroid injections administered once per week. Ultrasound guidance allows the physician to accurately deliver the medication into the affected area, improving safety and precision.

After the injections, participants are randomly assigned to one of two rehabilitation programs. One group performs a program based on Proprioceptive Neuromuscular Facilitation (PNF), a technique that uses specific movement patterns to improve muscle coordination, flexibility, and strength. The other group receives conventional physiotherapy, including standard exercises aimed at improving shoulder mobility and function.

Participants are evaluated over time to assess changes in pain, daily function, quality of life, and shoulder movement, with follow-up lasting up to six months.

The purpose of this study is to determine whether one rehabilitation approach is more effective than the other when combined with corticosteroid injections.

The study aims to answer the following question:

Does a rehabilitation program based on Proprioceptive Neuromuscular Facilitation (PNF), combined with ultrasound-guided corticosteroid injections, lead to better improvements in pain, function, quality of life, and shoulder mobility compared to conventional physiotherapy in patients with subacromial bursitis?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • University "Magna Graecia "of Catanzaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged ≥ 18 years
  • Diagnosis of chronic shoulder pain (duration ≥ 3 months)
  • Pain intensity ≥ 4 on the Numeric Rating Scale (NRS)
  • Body Mass Index (BMI) < 30 kg/m²
  • Ability to understand and provide written informed consent

Exclusion Criteria:

  • Severe cognitive impairment (Mini-Mental State Examination < 24) or inability to provide informed consent
  • Severe cardiovascular or cerebrovascular diseases
  • History of neurological or psychiatric disorders
  • Active oncological disease
  • Rheumatoid arthritis
  • Previous shoulder arthroplasty
  • Severe osteoporosis
  • Use of oral analgesics, intra-articular injections, physiotherapy, or physical therapies within 15 days prior to enrollment;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
Drug: Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy
Participants in this group receive a combined interventional and rehabilitative treatment. Initially, all patients undergo a cycle of three ultrasound-guided subacromial corticosteroid injections (metilprednisolone 40 mg) administered once weekly to reduce inflammation and pain. Following the injection phase, participants complete a conventional physiotherapy program consisting of supervised sessions including passive and active mobilization exercises, muscle strengthening, stretching, and proprioceptive training aimed at improving shoulder mobility, function, and overall physical performance.
Experimental: Study group
Drug: Ultrasound-Guided Corticosteroid Injections plus PNF
Participants in this group receive a combined interventional and rehabilitative treatment. Initially, all patients undergo a cycle of three ultrasound-guided subacromial corticosteroid injections (metilprednisolone 40 mg) administered once weekly to reduce inflammation and pain. Following the injection phase, participants complete a structured physiotherapy program based on Proprioceptive Neuromuscular Facilitation (PNF), consisting of supervised sessions aimed at improving shoulder mobility, muscle strength, coordination, and neuromuscular control through specific movement patterns and facilitation techniques.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity measured by the Numeric Rating Scale (NRS)
Time Frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater pain. Patients rated their average pain over the previous 24 hours at each timepoint (baseline and follow-up).
Baseline, 2 weeks, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Upper limb function (DASH)
Time Frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Upper limb function was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, a self-reported measure ranging from 0 to 100, where higher scores indicate greater disability. Participants completed the questionnaire at baseline and follow-up timepoints.
Baseline, 2 weeks, 1 month, 3 months, and 6 months
Health-related quality of life (EQ-5D-3L Index)
Time Frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Health-related quality of life was assessed using the EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Index, ranging from values below 0 (health states worse than death) to 1 (full health), where higher scores indicate better health status. The index was derived from patient responses to the EQ-5D-3L descriptive system at each assessment timepoint.
Baseline, 2 weeks, 1 month, 3 months, and 6 months
Perceived health status (EQ-VAS)
Time Frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Perceived health status was assessed using the EuroQol Visual Analogue Scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), where higher scores indicate better perceived health. Patients self-reported their health status at each assessment timepoint.
Baseline, 2 weeks, 1 month, 3 months, and 6 months
Shoulder Range of Motion (ROM)
Time Frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Shoulder range of motion was assessed using a goniometer, measuring active movements (flexion, abduction, and external rotation) in degrees. Higher values indicate better joint mobility. Measurements were performed at each assessment timepoint.
Baseline, 2 weeks, 1 month, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 380/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon reasonable request to the corresponding author, for researchers who provide a methodologically sound proposal. Data will be shared after approval by the study investigators and in compliance with applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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