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

NCT07508969 | Completed Phase 1

• 1 other identifier: 380/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Subacromial Bursitis of the Shoulder; Chronic Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 2 weeks, 1 month, 3 months, and 6 months

Secondary Outcomes (4)

• Upper limb function (DASH)

  Baseline, 2 weeks, 1 month, 3 months, and 6 months

• Health-related quality of life (EQ-5D-3L Index)

  Baseline, 2 weeks, 1 month, 3 months, and 6 months

• Perceived health status (EQ-VAS)

  Baseline, 2 weeks, 1 month, 3 months, and 6 months

• Shoulder Range of Motion (ROM)

  Baseline, 2 weeks, 1 month, 3 months, and 6 months

Study Arms (2)

Study group

EXPERIMENTAL

Drug: Ultrasound-Guided Corticosteroid Injections plus PNF

Control group

ACTIVE COMPARATOR

Drug: Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy

Interventions

Ultrasound-Guided Corticosteroid Injections plus PNF DRUG

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.

Study group

Ultrasound-Guided Corticosteroid Injections plus Conventional Physiotherapy DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

University "Magna Graecia "of Catanzaro

Catanzaro, CZ, 88100, Italy

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alessandro de Sire

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 2, 2026
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: May 29, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)