Comparing the Effects of Pelvic Alignment Versus Diaphragmatic Breathing on Shoulder Range of Motion
Primary Purpose
Glenohumeral Internal Rotation Deficit, Pelvic Misalignment, Diaphragmatic Breathing
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic alignment and forceful expiration
Pelvic repositioning exercise
Diaphragmatic breathing exercise
Sponsored by
About this trial
This is an interventional treatment trial for Glenohumeral Internal Rotation Deficit focused on measuring Shoulder, Pelvis, Regional interdependence, Diaphragm
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.
Sites / Locations
- University of North Georgia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Pelvic alignment and forceful expiration exercise
Pelvic repositioning exercise
Diaphragmatic breathing exercise
Arm Description
Outcomes
Primary Outcome Measures
Changes in shoulder internal rotation rang of motion
A Cybex isokinetic table will be used for standard positioning of the participants's arm. the participant will be positioned in supine, with his/her arm supported on the dynamometer's arm for shoulder assessment. Shoulder internal rotation range of motion will be assessed using the digital goniometer incorporated into the cybex dynamometer.
Changes in Maximal expiratory rate
A digital spirometer (EasyOne Plus Diagnostic Spirometry System) will be use for assessing maximal expiratory rate. A maximal expiratory test will be performed with the subject in sitting. A nose clip will be used to ensure all air is going into the manometer. Our measurements will be taken from total lung capacity, so the subject will first fully inhale, then fully exhale, pausing for 1-2 seconds at the end.
Secondary Outcome Measures
Change in pelvic alignment
Ober's test will be used to assess pelvic alignment. Limited hip joint adduction range of motion is considered as a positive test.
Full Information
NCT ID
NCT04255355
First Posted
January 29, 2020
Last Updated
March 30, 2020
Sponsor
University of North Georgia
1. Study Identification
Unique Protocol Identification Number
NCT04255355
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2020 (Anticipated)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glenohumeral Internal Rotation Deficit, Pelvic Misalignment, Diaphragmatic Breathing
Keywords
Shoulder, Pelvis, Regional interdependence, Diaphragm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pelvic alignment and forceful expiration exercise
Arm Type
Active Comparator
Arm Title
Pelvic repositioning exercise
Arm Type
Experimental
Arm Title
Diaphragmatic breathing exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pelvic alignment and forceful expiration
Intervention Description
The participant will be in supine with feet flat on a wall and the knees and hips flexed to 90 degrees. A standard 5" ball will be placed between the knees. The participant will hold a standard 9-inch balloon in the mouth with one hand. The subject will be instructed to isometrically contract the hamstrings to lift the ischium off the table while maintaining a posterior pelvic tilt. In this position, subject will be instructed to perform isometric hip adduction by squeezing the ball placed between the knees. The subject will then be instructed to breathe in through the nose and blow the air out into the balloon with full exhalation to activate the transverse and oblique abdominals. The participant will hold the breath for 3 seconds while maintaining hamstring contraction, adductor contraction, and transverse and oblique abdominal contraction. This process will be repeated four times. This exercise will be performed once daily under the supervision of the therapist for 5 days.
Intervention Type
Other
Intervention Name(s)
Pelvic repositioning exercise
Intervention Description
The participant will be positioned supine with their feet flat on a wall and the knees and hips flexed to 90 degrees. The subject will be instructed to isometrically contract the hamstrings to allow the ischial tuberosities to lift off the table while also maintaining a posterior pelvic tilt. The tailbone should be slightly lifted off the table, the abdominal muscles should be relaxed, and the low back should be flat on the table. While maintaining the posterior pelvic tilt, the subject will be instructed to perform isometric hip adduction by squeezing the ball that is placed between the knees. The subject will hold for 3 seconds and then relax. This process will be repeated four times. This exercise will be performed daily under the supervision of the therapist for 5 days.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing exercise
Intervention Description
For diaphragmatic breathing exercise, the subject will be in supine position. The investigator places both hands around the participant's lower ribs and abdominal area. The investigator applies slight manual resistance to the chest and abdominal wall during inhalation phase of breathing.The participant is instructed to apply outward pressure against the investigator resistance and to raise the chest and abdominal wall simultaneously with inhalation. Then participants performs a full exhalation and hold his/her breath for 3 seconds before breathing in again. This process is repeated for 4 breathing cycles. Participants will perform this exercise once a day under investigator supervision.
Primary Outcome Measure Information:
Title
Changes in shoulder internal rotation rang of motion
Description
A Cybex isokinetic table will be used for standard positioning of the participants's arm. the participant will be positioned in supine, with his/her arm supported on the dynamometer's arm for shoulder assessment. Shoulder internal rotation range of motion will be assessed using the digital goniometer incorporated into the cybex dynamometer.
Time Frame
Change from baseline internal rotation range of motion after 5 days of intervention
Title
Changes in Maximal expiratory rate
Description
A digital spirometer (EasyOne Plus Diagnostic Spirometry System) will be use for assessing maximal expiratory rate. A maximal expiratory test will be performed with the subject in sitting. A nose clip will be used to ensure all air is going into the manometer. Our measurements will be taken from total lung capacity, so the subject will first fully inhale, then fully exhale, pausing for 1-2 seconds at the end.
Time Frame
Change from baseline expiratory rate after 5 days of intervention
Secondary Outcome Measure Information:
Title
Change in pelvic alignment
Description
Ober's test will be used to assess pelvic alignment. Limited hip joint adduction range of motion is considered as a positive test.
Time Frame
Change from baseline hip adduction range of motion after 5 days of interventjion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad R Nourbakhsh, Ph.D
Phone
706 864 1766
Email
Reza.nourbakhsh@ung.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad R Nourbakhsh, PhD
Organizational Affiliation
University of North Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Georgia
City
Dahlonega
State/Province
Georgia
ZIP/Postal Code
30597
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
After the results have been published
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Comparing the Effects of Pelvic Alignment Versus Diaphragmatic Breathing on Shoulder Range of Motion
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