Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.
- Conditions
- Capsulitis of ShoulderHydrodilatation
- Registration Number
- NCT06939530
- Lead Sponsor
- Javier Muñoz Paz
- Brief Summary
Adhesive capsulitis (AC) causes a global limitation of active and passive range of motion (ROM) in the shoulder, with or without pain, and no other radiographic findings. The natural process is self-limiting, evolving in three or four phases. It is common in women around 50 years of age. Diagnosis is based on clinical symptoms, with imaging tests being nonspecific. Treatment options include physical therapy (PT), intra-articular corticosteroid injections, suprascapular nerve block (SSNB), and hydrodilatation (HD). The latter is useful for expanding and reducing inflammation of the joint capsule through insufflation with saline solution, anesthetics, and corticosteroids.
Objectives: To determine whether patients with AC, stratified by phase, who receive high-volume HD therapy achieve better outcomes in the Shoulder Pain and Disability Index (SPADI), Analgesic Analogue Scale (VAS), and ROM at the first, third, and sixth months of therapy compared to patients who receive low-volume HD. To determine whether there are differences in FST times and to determine mean axilar recess (AR) values.
Methods: A randomized, triple-blind, parallel-block clinical trial will be conducted in 64 patients with AC in phases 1 and 2, aged 30 to 70 years, with limited active and passive ROM in two planes, and shoulder pain lasting more than 3 months. HD will be administered with volumes of 20 ml or 40 ml, followed by a physical therapy program. Outcomes will be reviewed at the first, third, and sixth months of HD. Variables collected will include SPADI, VAS, ROM, Lattinen assessment, AR size, and time to completion of PT
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- Ages between 30 and 70 years.
- Limited ROM, both active and passive, in two planes.
- Shoulder pain lasting more than 3 months.
- Lidocaine + trial with improved ROM.
- Conditions that preclude treatment (active cancer, tissue infection, oral anticoagulant use, cardiac arrhythmias, etc.)
- Previously receiving HD treatment in less than 1 year.
- Stage 0 or 3 AC.
- Non-adherence to the PT program, with attendance failures exceeding 20%.
- Presence of conditions that can cause similar symptoms, such as acromioclavicular osteoarthritis, labral injury, massive rotator cuff tear, or rheumatic diseases.
- Intra-articular corticosteroid injection in less than 2 months.
- Technique failure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Shoulder pain and disability index (SPADI) Initial and 1 - 3 - 6 month after hydrodilatation The Shoulder Pain Disability Index is a widely used outcome measure in studies that provides information about pain and limitation of shoulder pathologies.
* Pain Scale How severe is the pain? 0 = no pain and 10 = the worst pain imaginable.
* At its worst?
* When lying on that side?
* When reaching for something on a high shelf?
* When touching the back of your neck?
* When pushing with the affected arm?
* Disability Scale:
How much difficulty do you have? 0 = no pain and 10 = the worst pain imaginable.
* Washing your hair.
* Washing your back.
* Putting on a T-shirt or sweater.
* Putting on a button-down shirt.
* Putting on your pants.
* Placing an object on a high shelf.
* Lifting a heavy object weighing 4.5 kilograms.
* Taking something from his back pocket.
Then, pain and disability are obtained separately, and a percentage of impairment is combined.
This index has demonstrated "good internal consistency, convergent validity, and reliability" in its Spanish version.Visual Analgesic Scale (VAS) Initial and 1 - 3 - 6 month after hydrodilatation The VAS "is a validated subjective measure for acute and chronic pain." It allows for the measurement of pain intensity with maximum reproducibility.
It consists of a 10-centimeter horizontal line, with the extreme expressions of a symptom at each end. To the left (0) is the absence or lowest intensity, and to the right (10) is the highest intensity. The patient is asked to mark the point on the line that indicates the intensity. The minimally detectable differences for the symptom level to be acceptable are 2 to 3 points.Range of motion assessment (ROM) Initial and 1 - 3 - 6 month after hydrodilatation Range of motion assessment is a basic practice in the study of shoulder pathologies, especially in the case of AC. ROM should be measured, both actively and passively.
The ROMs that will be assessed actively and passively will primarily be flexion, abduction, external rotation (with the arm at 90° of abduction, by asking the patient to show us the palm of their hand), and internal rotation (with the arm at 90° of abduction, by asking the patient to show us the back of their hand). All of these are measured with the PLURIMETER inclinometer.
- Secondary Outcome Measures
Name Time Method Axillary recess (AR) size Initial This will be measured using ultrasound with a longitudinal section of the AR. The patient will be placed supine with the shoulder abducted at 90° and the elbow flexed.
Time from star to end of physiotherapy From 1 session to a maximum of 3 months of PT They will begin the PT program in less than 3-5 days. The PT start and start date will be scheduled according to pre-established criteria.
The following criteria will be established for discontinuing PT treatment:
* No improvement of 15% in ROM after full HD after 16 sessions.
* Recovery of full ROM after 4 sessions.
* Increased pain that makes PT impossible.
* Maximum of 24 PT sessions.
It will be measured in days.
Trial Locations
- Locations (1)
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Hospital Universitario Reina Sofia🇪🇸Córdoba, SpainJavierContact608737909