Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff I… (NCT03293329) | Clinical Trial Compass
CompletedNot Applicable
Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries
Spain45 participantsStarted 2020-03-09
Plain-language summary
A randomised and controlled trial to people diagnosed with rotator cuff injuries who are divided into 3 groups of treatment: shoulder myofascial trigger points release, manual diaphragm release and diaphragm mobilization through hipopressive gymnastic exercise. The pain and range of shoulder movement are assessed before and after the treatment in all the participants.
Hypothesis of the clinical study: the treatment of diaphragm muscle, via manual release or active mobilization, has impact on rotator cuff injury symptoms comparing with a standard treatment of shoulder myofascial trigger points release.
Discussion: The relation between shoulder and diaphragm muscle, through innervation (phrenic nerve and brachial plexus), embryology and myofascial connections, could lead to include in clinical practice the examination and treatment of other structures besides shoulder girdle such as diaphragmatic region in rotator cuff injuries.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants of both genders aged between 18 and 65 years old
* Ultrasound and/or magnetic resonance imaging diagnosis of rotator cuff injury
* Pain or range of movement restriction in active shoulder flexion and/or abduction
Exclusion Criteria:
* Use of analgesic or anti-inflammatory drugs 72 hours prior to the study
* Individuals with glenohumeral instability due to shoulder luxation or subluxation or Bankart labrum injury
* Individuals who have received physical therapy treatment in last week
* Individuals who underwent thoracic or shoulder surgery or people suffering from rheumatisms
* Diabetic patients
* People with a diagnosed neurological pathology
* Individuals with a diagnosed mental health problem
* Not being able to understand and sign the informed consent and information sheet
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline to post intervention shoulder range of motion with a digital inclinometer
Timeframe: Baseline and Immediately Post Intervention
2
Change from baseline to post intervention pressure pain threshold in supraespinatus tendon and xiphoid process with a pressure algometer
Timeframe: Baseline and Immediately Post Intervention
3
Change from baseline to post intervention Numerical Rating Pain Scale in shoulder mobility
Timeframe: Baseline and Immediately Post Intervention