Glenohumeral Internal Rotation DeficitNCT04255355
Comparing the Effects of Pelvic Alignment Versus Diaphragmatic Breathing on Shoulder Range of Motion
A study testing Pelvic alignment and forceful expiration, Pelvic repositioning exercise and Diaphragmatic breathing exercise in people with Glenohumeral Internal Rotation Deficit and Pelvic Misalignment, run by University of North Georgia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Glenohumeral Internal Rotation Deficit, Pelvic Misalignment, Diaphragmatic Breathing
- What is being tested?
- Pelvic alignment and forceful expiration, Pelvic repositioning exercise and Diaphragmatic breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a unilateral positive Ober's test
- Having reduced (more than 15 degrees) shoulder internal rotation in the contralateral shoulder
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Georgia
Dahlonega, Georgia, 30597
About this study
Official title: Comparing the Effects of Pelvic Alignment and Diaphragmatic Breathing on Glenohumeral Internal Rotation Deficit (GIRD) - A Randomized Control Trial
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.
Read the 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.
- Being tested
- Pelvic alignment and forceful expiration, Pelvic repositioning exercise, Diaphragmatic breathing exercise
- Keywords
- Shoulder, Pelvis, Regional interdependence, Diaphragm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic alignment and forceful expirationOther
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.
Pelvic repositioning exerciseOther
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.
Diaphragmatic breathing exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic alignment and forceful expiration exercise | Active comparator | Not described Receives: Other: Pelvic alignment and forceful expiration |
| Pelvic repositioning exercise | Experimental | Not described Receives: Other: Pelvic repositioning exercise |
| Diaphragmatic breathing exercise | Experimental | Not described Receives: Other: Diaphragmatic breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline internal rotation range of motion after 5 days of intervention
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.
Measured: Change from baseline expiratory rate after 5 days of intervention
Secondary outcomes (1)
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.
Measured: Change from baseline hip adduction range of motion after 5 days of interventjion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Jul 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral Internal Rotation DeficitStudies 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad(Reza) Nourbakhsh, University of North Georgia
- Investigators
- Mohammad R Nourbakhsh, PhD, Principal investigator, University of North Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255355
- Sponsor's protocol ID
- IRB 2019-158
- Status last verified
- Mar 2020
- First submitted
- 29 Jan 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Pelvic Alignment and Diaphragmatic Breathing on Glenohumeral Internal Rotation Deficit (GIRD) - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04255355
- Acronym / sponsor ID
- IRB 2019-158
- Keywords
- Shoulder, Pelvis, Regional interdependence, Diaphragm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of North GeorgiaUniversity, hospital or other
- Study start
- 30 Jul 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 5 Feb 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pelvic alignment and forceful expiration exercise | Active comparator | Other: Pelvic alignment and forceful expiration |
| Pelvic repositioning exercise | Experimental | Other: Pelvic repositioning exercise |
| Diaphragmatic breathing exercise | Experimental | Other: Diaphragmatic breathing exercise |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having a unilateral positive Ober's test
- Having reduced (more than 15 degrees) shoulder internal rotation in the contralateral shoulder
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Pelvic alignment and forceful expirationThe 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. | Other | Pelvic alignment and forceful expiration exercise |
| Pelvic repositioning exerciseThe 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. | Other | Pelvic repositioning exercise |
| Diaphragmatic breathing exerciseFor 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. | Other | Diaphragmatic breathing exercise |
Primary outcome
Changes in shoulder internal rotation rang of motion
Time frame: Change from baseline internal rotation range of motion after 5 days of intervention
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
Time frame: Change from baseline expiratory rate after 5 days of intervention
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.
1 secondary outcome
Change in pelvic alignment
Time frame: Change from baseline hip adduction range of motion after 5 days of interventjion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
Mohammad R Nourbakhsh, PhD principal investigator
University of North Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic alignment and forceful expiration, Pelvic repositioning exercise and Diaphragmatic breathing exercise in people with Glenohumeral Internal Rotation Deficit and Pelvic Misalignment, run by University of North Georgia at 1 site in United States.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad R Nourbakhsh, Ph.D (706 864 1766, Reza.nourbakhsh@ung.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in shoulder internal rotation rang of motion (time frame: Change from baseline internal rotation range of motion after 5 days of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2020.