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NCT Number: NCT07508969

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

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?

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Key information

Conditions

Subacromial Bursitis of the Shoulder Chronic Shoulder Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University "Magna Graecia "of Catanzaro

Catanzaro, CZ, 88100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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