Subacromial Bursitis of the ShoulderPhase 1/2NCT07508969
Proprioceptive Neuromuscular Facilitation vs Conventional Therapy With Ultrasound-Guided Corticosteroid Injections for Subacromial Bursitis
A Phase 1/2 study testing Ultrasound-Guided Corticosteroid Injections plus PNF and Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy in people with Subacromial Bursitis of the Shoulder and Chronic Shoulder Pain, run by University of Catanzaro at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Bursitis of the Shoulder, Chronic Shoulder Pain
- What is being tested?
- Ultrasound-Guided Corticosteroid Injections plus PNF and Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 29 May 2025
- Phase
- Phase 1/2
- 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
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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?
- Being tested
- Ultrasound-Guided Corticosteroid Injections plus PNF, Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Corticosteroid Injections plus PNFDrug
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.
Ultrasound-Guided Corticosteroid Injections plus Conventional PhysiotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Drug: Ultrasound-Guided Corticosteroid Injections plus PNF |
| Control group | Active comparator | Not described Receives: Drug: Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured by the Numeric Rating Scale (NRS)
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).
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Secondary outcomes (4)
Upper limb function (DASH)
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.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Health-related quality of life (EQ-5D-3L Index)
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.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Perceived health status (EQ-VAS)
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.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Shoulder Range of Motion (ROM)
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.
Measured: Baseline, 2 weeks, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Mar 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Bursitis of the ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De Sire Alessandro, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508969
- Sponsor's protocol ID
- 380/2024
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Proprioceptive Neuromuscular Facilitation Versus Conventional Physical Therapy, Combined With Ultrasound-guided Corticosteroids Injections, in Subacromial Bursitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07508969
- Acronym / sponsor ID
- 380/2024
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Ultrasound-Guided Corticosteroid Injections plus PNF |
| Control group | Active comparator | Drug: Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Corticosteroid Injections plus PNFParticipants 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. | Drug | Study group |
| Ultrasound-Guided Corticosteroid Injections plus Conventional PhysiotherapyParticipants 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. | Drug | Control group |
Primary outcome
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).
4 secondary outcomes
Upper limb function (DASH)
Time frame: 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
Perceived health status (EQ-VAS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Subacromial Bursitis of the Shoulder
Recruiting
The Effect of an Exercise Program Based on Attentional Focus Shifting on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
Rotator Cuff Related Shoulder Pain, Subacromial Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ultrasound-Guided Corticosteroid Injections plus PNF and Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy in people with Subacromial Bursitis of the Shoulder and Chronic Shoulder Pain, run by University of Catanzaro at 1 site in Italy.
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 5 inclusion and 8 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 2 Apr 2026. 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 Italy. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 intensity measured by the Numeric Rating Scale (NRS) (time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.