Capsulitis of ShoulderHYCAFVOLNCT06939530
Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.
A study testing Hydrodilatation (20 ml) and Hydrodilatation (40 ml) in people with Capsulitis of Shoulder and Hydrodilatation, run by Javier Muñoz Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Capsulitis of Shoulder, Hydrodilatation
- What is being tested?
- Hydrodilatation (20 ml) and Hydrodilatation (40 ml)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 30 and 70 years.
- Limited ROM, both active and passive, in two planes.
- Shoulder pain lasting more than 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
Javier, 608737909
About this study
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
- Conditions
- Capsulitis of Shoulder, Hydrodilatation
- Being tested
- Hydrodilatation (20 ml), Hydrodilatation (40 ml)
- Keywords
- Adhesive Capsulitis, frozen shoulder, hydrodilatation, suprascapular nerve block
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrodilatation (20 ml)Procedure or surgery
First, an SSNB will be performed with 4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch.
After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the patient will be placed in a lateral decubitus position on the unaffected arm. The arm to be treated will be positioned at the patient's side without forcing its extension. The joint cavity will then be approached posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 20 ml.
Hydrodilatation (40 ml)Procedure or surgery
First, an SSNB will be performed with 4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch.
After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the patient will be placed in a lateral decubitus position on the unaffected arm. The arm to be treated will be positioned at the patient's side without forcing its extension. The joint cavity will then be approached posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 40 ml.
| Study group | Role | What they receive |
|---|---|---|
| Adhesive Capsulitis Phase 1 | Active comparator | Adhesive Capsulitis Phase 1 --> Patients in phase 1 will be considered as those in which the predominant clinical picture is pain accompanied by limitation of ROM Receives: Procedure: Hydrodilatation (20 ml); Procedure: Hydrodilatation (40 ml) |
| Adhesive Capsulitis Phase 2 | Active comparator | Adhesive Capsulitis Phase 2 --> Patients in whom ROM limitation predominates in the face of pain. Receives: Procedure: Hydrodilatation (20 ml); Procedure: Hydrodilatation (40 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain and disability index (SPADI)
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.
Measured: Initial and 1 - 3 - 6 month after hydrodilatation
Visual Analgesic Scale (VAS)
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.
Measured: Initial and 1 - 3 - 6 month after hydrodilatation
Range of motion assessment (ROM)
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.
Measured: Initial and 1 - 3 - 6 month after hydrodilatation
Secondary outcomes (2)
Axillary recess (AR) size
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.
Measured: Initial
Time from star to end of physiotherapy
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.
Measured: From 1 session to a maximum of 3 months of PT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start2 Feb 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Capsulitis of 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ensayo clínico aleatorizado por bloques en paralelo con triple cegamiento.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Javier Muñoz Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Córdoba, Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Hospital Universitario Reina Sofia de Cordoba
- Responsible party
- Sponsor-investigator, Javier Muñoz Paz, Maimónides Biomedical Research Institute of Córdoba
- Investigators
- Javier Muñoz Paz, degree in medicine, Principal investigator, Hospital Universitario Reina Sofia de CordobaFernando J Mayordomo Riera, Head of service, Study director, Hospital Universitario Reina Sofia de CordobaJose Peña Amaro, Professor of Histology - UCO, Study director, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939530
- Sponsor's protocol ID
- HYCAFVOL
- Acronym
- HYCAFVOL
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stella SM, Gualtierotti R, Ciampi B, Trentanni C, Sconfienza LM, Del Chiaro A, Pacini P, Miccoli M, Galletti S. Ultrasound Features of Adhesive Capsulitis. Rheumatol Ther. 2022 Apr;9(2):481-495. doi: 10.1007/s40744-021-00413-w. Epub 2021 Dec 23.
PubMed 34940958González-Escalada JR, Camba A, Muriel C, Rodríguez M, Contreras D, De Barutell C. Validación del índice de Lattinen para la evaluación del paciente con dolor crónico. Vol. 19, Rev Soc Esp Dolor. 2012.
Vicente Herrero MT, Delgado Bueno S, Bandrés Moyá F, Ramírez Iñiguez de la Torre MV, Capdevila García L. Valoración del dolor. Revisión Comparativa de Escalas y Cuestionarios. Revista de la Sociedad Española del Dolor. 2018.
Membrilla-Mesa MD, Cuesta-Vargas AI, Pozuelo-Calvo R, Tejero-Fernandez V, Martin-Martin L, Arroyo-Morales M. Shoulder pain and disability index: cross cultural validation and evaluation of psychometric properties of the Spanish version. Health Qual Life Outcomes. 2015 Dec 21;13:200. doi: 10.1186/s12955-015-0397-z.
PubMed 26690943Paruthikunnan SM, Shastry PN, Kadavigere R, Pandey V, Karegowda LH. Intra-articular steroid for adhesive capsulitis: does hydrodilatation give any additional benefit? A randomized control trial. Skeletal Radiol. 2020 May;49(5):795-803. doi: 10.1007/s00256-019-03316-8. Epub 2019 Dec 17.
PubMed 31844950Lin CL, Lee YH, Chen YW, Liao CD, Huang SW. Predictive Factors of Intra-articular Corticosteroid Injections With Ultrasound-Guided Posterior Capsule Approach for Patients With Primary Adhesive Capsulitis. Am J Phys Med Rehabil. 2024 Mar 1;103(3):215-221. doi: 10.1097/PHM.0000000000002340. Epub 2023 Sep 22.
PubMed 37752075Lee JH, Lee JH, Chang MC. Association of Range of Motion Deficit and Recurrence of Pain After Treatment of Adhesive Capsulitis. Pain Ther. 2024 Apr;13(2):241-249. doi: 10.1007/s40122-024-00578-6. Epub 2024 Feb 5.
PubMed 38315379de Sire A, Agostini F, Bernetti A, Mangone M, Ruggiero M, Dinatale S, Chiappetta A, Paoloni M, Ammendolia A, Paolucci T. Non-Surgical and Rehabilitative Interventions in Patients with Frozen Shoulder: Umbrella Review of Systematic Reviews. J Pain Res. 2022 Aug 19;15:2449-2464. doi: 10.2147/JPR.S371513. eCollection 2022.
PubMed 36016536Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.
PubMed 31475043Shanahan EM, Gill TK, Briggs E, Hill CL, Bain G, Morris T. Suprascapular nerve block for the treatment of adhesive capsulitis: a randomised double-blind placebo-controlled trial. RMD Open. 2022 Nov;8(2):e002648. doi: 10.1136/rmdopen-2022-002648.
PubMed 36418088Jung TW, Lee SY, Min SK, Lee SM, Yoo JC. Does Combining a Suprascapular Nerve Block With an Intra-articular Corticosteroid Injection Have an Additive Effect in the Treatment of Adhesive Capsulitis? A Comparison of Functional Outcomes After Short-term and Minimum 1-Year Follow-up. Orthop J Sports Med. 2019 Jul 23;7(7):2325967119859277. doi: 10.1177/2325967119859277. eCollection 2019 Jul.
PubMed 31384617Pimenta M, Vassalou EE, Klontzas ME, Dimitri-Pinheiro S, Ramos I, Karantanas AH. Ultrasound-guided hydrodilatation for adhesive capsulitis: capsule-preserving versus capsule-rupturing technique. Skeletal Radiol. 2024 Feb;53(2):253-261. doi: 10.1007/s00256-023-04392-7. Epub 2023 Jul 3.
PubMed 37400605Whelan G, Yeowell G, Littlewood C. Patient experiences of hydrodistension as a treatment for frozen shoulder: A longitudinal qualitative study. PLoS One. 2024 Jun 14;19(6):e0304236. doi: 10.1371/journal.pone.0304236. eCollection 2024.
PubMed 38875237Swaroop S, Gupta P, Patnaik S, Reddy SS. Intra-articular Steroid alone vs Hydrodilatation with intra-articular Steroid in Frozen Shoulder - A Randomised Control Trial. Malays Orthop J. 2023 Mar;17(1):34-39. doi: 10.5704/MOJ.2303.005.
PubMed 37064640Vita F, Pederiva D, Tedeschi R, Spinnato P, Origlio F, Faldini C, Miceli M, Stella SM, Galletti S, Cavallo M, Pilla F, Donati D. Adhesive capsulitis: the importance of early diagnosis and treatment. J Ultrasound. 2024 Sep;27(3):579-587. doi: 10.1007/s40477-024-00891-y. Epub 2024 Jun 6.
PubMed 38844748
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.
- ClinicalTrials.gov ID
- NCT06939530
- Acronym / sponsor ID
- HYCAFVOL / HYCAFVOL
- Conditions
- Capsulitis of Shoulder, Hydrodilatation
- Keywords
- Adhesive Capsulitis, frozen shoulder, hydrodilatation, suprascapular nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Javier Muñoz PazUniversity, hospital or other
- Collaborators
- Universidad de Córdoba, Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Hospital Universitario Reina Sofia de Cordoba
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 23 Apr 2025 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Ensayo clínico aleatorizado por bloques en paralelo con triple cegamiento.
| Arm | Type | Receives |
|---|---|---|
| Adhesive Capsulitis Phase 1 | Active comparator | Procedure: Hydrodilatation (20 ml), Procedure: Hydrodilatation (40 ml)Adhesive Capsulitis Phase 1 --> Patients in phase 1 will be considered as those in which the predominant clinical picture is pain accompanied by limitation of ROM |
| Adhesive Capsulitis Phase 2 | Active comparator | Procedure: Hydrodilatation (20 ml), Procedure: Hydrodilatation (40 ml)Adhesive Capsulitis Phase 2 --> Patients in whom ROM limitation predominates in the face of pain. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages between 30 and 70 years.
- Limited ROM, both active and passive, in two planes.
- Shoulder pain lasting more than 3 months.
Key exclusion criteria (8 listed)
- 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%.
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 |
|---|---|---|
| Hydrodilatation (20 ml)First, an SSNB will be performed with 4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch. After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the patient will be placed in a lateral decubitus position on the unaffected arm. The arm to be treated will be positioned at the patient's side without forcing its extension. The joint cavity will then be approached posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 20 ml. | Procedure or surgery | Adhesive Capsulitis Phase 1, Adhesive Capsulitis Phase 2 |
| Hydrodilatation (40 ml)First, an SSNB will be performed with 4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch. After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the patient will be placed in a lateral decubitus position on the unaffected arm. The arm to be treated will be positioned at the patient's side without forcing its extension. The joint cavity will then be approached posteriorly, introducing a spinal needle in the ultrasound plane between the humeral cortex and the labrum. The joint cavity will then be confirmed by introducing physiological saline solution and observing its reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of corticosteroid will be introduced, and the corresponding volume will be completed with saline solution, this case 40 ml. | Procedure or surgery | Adhesive Capsulitis Phase 1, Adhesive Capsulitis Phase 2 |
Primary outcome
Shoulder pain and disability index (SPADI)
Time frame: 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)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Axillary recess (AR) size
Time frame: Initial
Time from star to end of physiotherapy
Time frame: From 1 session to a maximum of 3 months of PT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Background: PubMed 34940958Stella SM, Gualtierotti R, Ciampi B, Trentanni C, Sconfienza LM, Del Chiaro A, Pacini P, Miccoli M, Galletti S. Ultrasound Features of Adhesive Capsulitis. Rheumatol Ther. 2022 Apr;9(2):481-495. doi: 10.1007/s40744-021-00413-w. Epub 2021 Dec 23.
- BackgroundGonzález-Escalada JR, Camba A, Muriel C, Rodríguez M, Contreras D, De Barutell C. Validación del índice de Lattinen para la evaluación del paciente con dolor crónico. Vol. 19, Rev Soc Esp Dolor. 2012.
- BackgroundVicente Herrero MT, Delgado Bueno S, Bandrés Moyá F, Ramírez Iñiguez de la Torre MV, Capdevila García L. Valoración del dolor. Revisión Comparativa de Escalas y Cuestionarios. Revista de la Sociedad Española del Dolor. 2018.
- Background: PubMed 26690943Membrilla-Mesa MD, Cuesta-Vargas AI, Pozuelo-Calvo R, Tejero-Fernandez V, Martin-Martin L, Arroyo-Morales M. Shoulder pain and disability index: cross cultural validation and evaluation of psychometric properties of the Spanish version. Health Qual Life Outcomes. 2015 Dec 21;13:200. doi: 10.1186/s12955-015-0397-z.
- Background: PubMed 31844950Paruthikunnan SM, Shastry PN, Kadavigere R, Pandey V, Karegowda LH. Intra-articular steroid for adhesive capsulitis: does hydrodilatation give any additional benefit? A randomized control trial. Skeletal Radiol. 2020 May;49(5):795-803. doi: 10.1007/s00256-019-03316-8. Epub 2019 Dec 17.
- Background: PubMed 37752075Lin CL, Lee YH, Chen YW, Liao CD, Huang SW. Predictive Factors of Intra-articular Corticosteroid Injections With Ultrasound-Guided Posterior Capsule Approach for Patients With Primary Adhesive Capsulitis. Am J Phys Med Rehabil. 2024 Mar 1;103(3):215-221. doi: 10.1097/PHM.0000000000002340. Epub 2023 Sep 22.
- Background: PubMed 38315379Lee JH, Lee JH, Chang MC. Association of Range of Motion Deficit and Recurrence of Pain After Treatment of Adhesive Capsulitis. Pain Ther. 2024 Apr;13(2):241-249. doi: 10.1007/s40122-024-00578-6. Epub 2024 Feb 5.
- Background: PubMed 36016536de Sire A, Agostini F, Bernetti A, Mangone M, Ruggiero M, Dinatale S, Chiappetta A, Paoloni M, Ammendolia A, Paolucci T. Non-Surgical and Rehabilitative Interventions in Patients with Frozen Shoulder: Umbrella Review of Systematic Reviews. J Pain Res. 2022 Aug 19;15:2449-2464. doi: 10.2147/JPR.S371513. eCollection 2022.
- Background: PubMed 31475043Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.
- Background: PubMed 36418088Shanahan EM, Gill TK, Briggs E, Hill CL, Bain G, Morris T. Suprascapular nerve block for the treatment of adhesive capsulitis: a randomised double-blind placebo-controlled trial. RMD Open. 2022 Nov;8(2):e002648. doi: 10.1136/rmdopen-2022-002648.
- Background: PubMed 31384617Jung TW, Lee SY, Min SK, Lee SM, Yoo JC. Does Combining a Suprascapular Nerve Block With an Intra-articular Corticosteroid Injection Have an Additive Effect in the Treatment of Adhesive Capsulitis? A Comparison of Functional Outcomes After Short-term and Minimum 1-Year Follow-up. Orthop J Sports Med. 2019 Jul 23;7(7):2325967119859277. doi: 10.1177/2325967119859277. eCollection 2019 Jul.
- Background: PubMed 37400605Pimenta M, Vassalou EE, Klontzas ME, Dimitri-Pinheiro S, Ramos I, Karantanas AH. Ultrasound-guided hydrodilatation for adhesive capsulitis: capsule-preserving versus capsule-rupturing technique. Skeletal Radiol. 2024 Feb;53(2):253-261. doi: 10.1007/s00256-023-04392-7. Epub 2023 Jul 3.
- Frozen shoulder adhesive capsulitis - UpToDateLink provided by the sponsor.
- Physical examination of the shoulder- UpToDateLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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.
Javier Muñoz Paz, degree in medicine principal investigator
Hospital Universitario Reina Sofia de Cordoba
Fernando J Mayordomo Riera, Head of service study director
Hospital Universitario Reina Sofia de Cordoba
Jose Peña Amaro, Professor of Histology - UCO study director
Universidad de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrodilatation (20 ml) and Hydrodilatation (40 ml) in people with Capsulitis of Shoulder and Hydrodilatation, run by Javier Muñoz Paz at 1 site in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 23 Apr 2025. 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 Spain. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Muñoz Paz, degree in medicine (608737909 ext. +34, javimp1395@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain and disability index (SPADI) (time frame: Initial and 1 - 3 - 6 month after hydrodilatation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06939530, which also lists 41 linked publications.
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 23 Apr 2025.