Clinical trial NCT03293329: Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries
Official title: Effects of Diaphragm Muscle Therapy on Pain and Shoulder Movement in Subjects With Rotator Cuff Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injury
Diaphragm; Relaxation
Keywords: rotator cuff injury
diaphragm
physical therapy
manual therapy
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study is a randomised controlled trial evaluating clinical effects of a diaphragm treatment, via manual release or active mobilization, comparing with a standard treatment of shoulder myofascial trigger points release.

A description of the 3 groups of treatment:

1. - Experimental group 1: 3 diaphragm stretching techniques according to Chaitow, Ward and Ricard, performed by a physical therapist are employed in this experimental group during 10 minutes. The participants are situated in a seated, supine and side bending position.
2. - Experimental group 2: diaphragm mobilization through active hipopressive gymnastic exercise according to Caufriez in two different postures.
3. - Active comparator group: A ischemic compression technique in most painful myofascial trigger points in the infraespinatus and supraespinatus muscle during one minute each one.

The shoulder flexion, abduction and external rotation range of motion will be assessed pre and postinterventions, as well as the pressure pain threshold with an algometer and the pain experienced by the individual in shoulder mobility with a Numerical Rating Scale.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to post intervention shoulder range of motion with a digital inclinometer
timeFrame: Baseline and Immediately Post Intervention
measure: 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
measure: Change from baseline to post intervention Numerical Rating Pain Scale in shoulder mobility
timeFrame: Baseline and Immediately Post Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References: