Clinical trial NCT04255355: Comparing the Effects of Pelvic Alignment Versus Diaphragmatic Breathing on Shoulder Range of Motion
Official title: Comparing the Effects of Pelvic Alignment and Diaphragmatic Breathing on Glenohumeral Internal Rotation Deficit (GIRD) - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glenohumeral Internal Rotation Deficit
Pelvic Misalignment
Diaphragmatic Breathing
Keywords: Shoulder
Pelvis
Regional interdependence
Diaphragm
Lead sponsor: University of North Georgia
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research study is to compare the effects of pelvic alignment versus diaphragmatic breathing on range of motion in the shoulder joint in both athletic and nonathletic population. The investigators plan to have approximately 45 participants to take part in this study. Subjects will be assigned into three groups. Group 1 will perform both pelvic alignment and diaphragmatic breathing exercises. This group will be used as the standard or control group. Group 2 will perform pelvic alignment exercise only; and Group 3 will perform diaphragmatic exercises only. The shoulder internal rotation range will be assessed in all three groups. Maximal expiratory rate will be measured in group 3 to assure improved diaphragmatic breathing in subjects. The shoulder internal rotation range in group 2 \& 3 will be compared to the shoulder range of motion in the standard group.

Detailed description: Study design This study is a randomized, blinded, pretest-posttest control group experimental design comparing the effects of pelvic alignment vs. diaphragmatic breathing on Glenohumeral Internal Rotation Deficit (GIRD). Protection of the subjects' rights will be secured through a signed informed consent form approved by the university Institutional Review Board.

Subject selection, randomization, and blinding process: Using statistical power analysis 45 healthy, college aged participants are needed for this study. These subjects will be volunteers and recruited by word of mouth by campus professors, coaches and physical therapy students and faculty.

Intervention timeline: Baseline assessment (pretest), five treatment sessions and a posttest. The time required by subjects will be between five and seven days total with each immediately succeeding the next. Treatment sessions will be approximately 10 minutes each. If any portion of this timeline happens to fall outside of the university operational hours, then the intervention will resume the following day. Subjects will be informed of their rights to receive the results of their assessments following the conclusion of the study. Two of the investigators will perform the initial screenings, groups assignments and treatments for all subjects. The other two investigators, who are blinded on participant's group assignment will perform all pretest and posttest measurements. Intraclass Correlation Coefficient model (3,3) will be used, in a pilot study, to assess inter-rater and intra-rater reliability for all testing procedures.

Testing Procedures:

The primary measurements include Ober's test, assessment of shoulder internal rotation range of motion, and spirometry measurements of maximal expiratory rate.

Range of motion assessment: A Cybex isokinetic table will be used to measure passive shoulder internal rotation range of motion. The Cybex will provide standardized arm position and accurate digital measurement of the shoulder internal rotation bilaterally. All pretest and posttest ROM measurements will be performed by the same examiners.

Pelvic alignment assessment: Ober's test will be used to assess pelvic alignment. Although this test is widely known as an assessment of iliotibial band/fascia lata length, it was originally used to assess pelvic alignment. It has been suggested that a unilateral positive Ober's test is indicative of hemipelvic anterior tilt and forward rotation, which leads to a bony block of the rim of the acetabulum on the femoral neck. This bony block would decrease the amount of adduction, leading to a positive Ober's test.

Craig's test will be used during the screening process to assess presence of excessive femoral anteversion angle.

Spirometry: A digital spirometer is used for measuring maximal expiratory rate.

Treatment Procedures:

Neuromuscular Exercise for combined Pelvic Alignment and Diaphragmatic Breathing:

Pelvic alignment and diaphragmatic breathing exercise included simultaneous activation of the hamstring, hip adductor and transverse abdominal muscles with forceful exhalation.

Pelvic Alignment Exercises: Pelvic alignment involves simultaneous activation of the hamstring muscles and hip adductors to reset pelvic symmetry.

Diaphragmatic Breathing exercise: Diaphragmatic breathing involves subject education for simultaneous rise of chest and abdominal wall with inhalation.

Eligibility criteria: Inclusion Criteria

* Having a unilateral positive Ober's test
* Having reduced (more than 15 degrees) shoulder internal rotation in the contralateral shoulder

Exclusion Criteria

* Having a positive Craig's test
* Having bilateral positive Ober's test
* Structural leg length discrepancies
* Having shoulder pain, back pain or any other musculoskeletal pain or dysfunctions
* Having any other medical conditions that prevents them from performing physical exercise
* Having any respiratory or other medical conditions that prevents them from performing deep breathing and expiratory exercises.

Primary outcomes:
measure: Changes in shoulder internal rotation rang of motion
timeFrame: Change from baseline internal rotation range of motion after 5 days of intervention
measure: Changes in Maximal expiratory rate
timeFrame: Change from baseline expiratory rate after 5 days of intervention
Secondary outcomes:
measure: Change in pelvic alignment
timeFrame: Change from baseline hip adduction range of motion after 5 days of interventjion
Other outcomes:
Locations:
city: Dahlonega
country: United States
facility: University of North Georgia
state: Georgia
Study officials:
affiliation: University of North Georgia
name: Mohammad R Nourbakhsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: