Hip Alignment and Shoulder RotationNCT03022305
Pelvic Alignment and Shoulder Function
A study testing Group one - standard therapy and Group two - neuromuscular therapy in people with Hip Alignment and Shoulder Rotation, run by University of North Georgia.
Trial summary
The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more effective in improving range of motion and torque production at the shoulder joint than traditional exercises for improving hip internal rotation and adduction range of motion. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Alignment and Shoulder Rotation
- What is being tested?
- Group one - standard therapy and Group two - neuromuscular therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to May 2016
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- College-aged students between the ages of 18 and 25,
- Having limited hip ROM than the normal ranges suggested by the AAOS guidelines,
- Having positive Ober and Thomas tests,
Who cannot join
- Having known shoulder pathologies,
- Structural leg length discrepancies,
- Having any cardiovascular, respiratory or other health problems
- Require use of an assistive device for ambulation,
- Amputees, and people with structural deformities of the shoulder or hip joint.
About this study
Official title: The Effects of Pelvic Alignment on Shoulder Range of Motion and Torque Production
The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more effective in improving range of motion and torque production at the shoulder joint than traditional exercises for improving hip internal rotation and adduction range of motion.
Read the detailed description
Current literature shows a relationship between hip joint flexibility and shoulder range of motion and torque production in athletes and the general population. It is well established that limited hip joint internal rotation and adduction, specifically in baseball players, results in limited trunk rotation during pitching phase of throwing. Due to restricted rotation range at the hip joint, athletes try to compensate for the diminished rotational momentum of the trunk by producing excessive external rotation at the shoulder joint during the cocking phase of throwing. Such compensation results in laxity and overstressed shoulder joint structures. In the long term, increased laxity of the joint affects normal muscle mechanics and results in decreased torque production at the shoulder joint.
The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more effective in improving range of motion and torque production at the shoulder joint than traditional exercises for improving hip internal rotation and adduction range of motion.
Group assignment:
An equal number of male and female subjects will be randomly assigned into one of three groups:
Group one will have standard treatment for improving hip range of motion. Group two will receive the new neuromuscular approach for improving pelvic alignment.
Group three will receive no treatment.
Participants and the examiners will be blinded to subjects' group assignment. Researchers will inform the subjects that they will be randomly assigned to a group with an exercise program in one of two timeframes: immediately after the initial assessment or after a one-week waiting period. Subjects in the control group will wait for one week, and then they will be asked to be tested one more time to make sure that the subject's physical condition did not change. At this time, these subjects will be informed of participation in the control group and will be given the option of going through the treatment program of choice. The neuromuscular treatment will also be offered to subjects in the standard group at the conclusion of the data collection period.
Testing procedures:
In a pretest session, the examiner, using a standard goniometer, will measure each participant's hip flexion, extension, adduction, abduction, internal rotation, and external rotation passive range of motion in seated position. Then the examiner will assess each participant's pelvic alignment using the Ober test and Thomas test. Shoulder range of motion will also be assessed using the standard goniometry procedures in the seated position. Shoulder torque production will be assessed using a Biodex isokinetic dynamometer.
The following parameters will be assessed using standard physical therapy techniques:
Hip Joint Assessment Hip range of motion assessment Hip Flexion Hip Extension Hip abduction Hip adduction Hip internal rotation Hip external rotation Ober test: [While the lower extremity is still neutral in the transverse plane, the examiner will allow the leg to slowly be lowered into full adduction. The test is considered positive if the knee joint does not reach the examination table. This test will be conducted for both sides.] Thomas test: [While holding the flexed knee to the chest, the participant will slowly lie back into a supine position on the examination table with the opposite leg hanging freely over the edge of the table. The test is considered positive if the free hanging leg is raised off the table with subject lying in supine position. This test will be conducted for both lower extremities.] Shoulder Joint Assessment Shoulder range of motion assessment Shoulder Flexion Shoulder Extension Shoulder Abduction Shoulder Internal Rotation Shoulder External Rotation Assessment of shoulder torque production: [Assessed by a Biodex isokinetic dynamometer.]
Treatment procedures:
Treatment procedure for group one:
Subjects in the standard treatment group will perform 10 repetitions of active hip internal rotation, external rotation, abduction, adduction, flexion and extension exercises daily, under supervision of the treating therapist.
Treatment neuromuscular training for group two:
Subjects in this group will perform the neuromuscular treatment for pelvic alignment, as suggested by Postural Restoration Institute, once a day under treating therapist supervision for one week. Subject will flex the hip and knee joints to 90° and will rest both feet against the wall with a standard 4 - 6" ball will be placed between the subject's knees. At this position, the subject is instructed to squeeze the ball between the knees and to perform an isometric hamstring muscle contraction (statically pulling the feet downward without pressing to the wall). At this point, the subject will be instructed to perform a gentle posterior pelvic tilt while avoiding abdominal muscle contraction. While maintaining this position, the subject is instructed to take a deep breath in through the nose and then slowly blow out into the balloon. The subject will be instructed to pause for 3 seconds while pressing the tongue to the roof the mouth to prevent airflow out of the balloon. After the 4th breath in, the subject will pinch the neck of the balloon and remove it from the mouth. Then subject will relax and take the feet off the wall. This exercise will be repeated daily for one week (Monday through Friday). Following neuromuscular training exercise, the patient will perform a coordinated hip internal and external rotation exercise in side lying.
The no treatment group will act as a control group. Both the standard and no treatment group will be offered free neuromuscular treatment at the conclusion of posttest data collection.
- Conditions
- Hip Alignment and Shoulder Rotation
- Being tested
- Group one - standard therapy, Group two - neuromuscular therapy
- Keywords
- Hip alignment, Hip misalignment, Shoulder function, Shoulder rotation, Athletic shoulder injuries, Athletic hip alignment, Hip and shoulder alignment, Hip joint, Hip joint alignment, Hip joint misalignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group one - standard therapyBehavioural
Group two - standard physical therapy treatment for shoulder and hip maladjustment.
Group two - neuromuscular therapyBehavioural
Use of physical therapy treatment for shoulder and hip maladjustment.
| Study group | Role | What they receive |
|---|---|---|
| Group one - standard therapy | Experimental | Standard physical therapy treatment for shoulder and hip malalignment will be administered for one week. Receives: Behavioral: Group one - standard therapy |
| Group two - neuromuscular therapy | Experimental | Experimental neuromuscular physical therapy treatment for shoulder and hip malalignment will be administered for one week. This therapy is exercised based. Receives: Behavioral: Group two - neuromuscular therapy |
| Group three - no treatment | No intervention | No physical therapy treatment will be given to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic realignment achieved as indicated by negative Ober test on examination at completion of the training period..
Results of the three groups, (1) standard conditioning, (2) neuromuscular conditioning, and (3) no conditioning, will be assessed for pelvic realignment following one week of each of these therapies.
Measured: Outcomes will be assessed following one week for each of the therapy groups.
Secondary outcomes (1)
Pelvic realignment achieved as indicated by negative Thomas test on examination at completion of the training period..
Results of the three groups, (1) standard conditioning, (2) neuromuscular conditioning, and (3) no conditioning, will be assessed for pelvic realignment following one week of each of these therapies.
Measured: Outcomes will be assessed following one week for each of the therapy groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip Alignment and Shoulder RotationStudies 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
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reza Nourbakhsh, PhD, Principal investigator, University of North Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022305
- Sponsor's protocol ID
- IRB 201561
- Status last verified
- Jan 2017
- First submitted
- 22 Nov 2016
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Robb AJ, Fleisig G, Wilk K, Macrina L, Bolt B, Pajaczkowski J. Passive ranges of motion of the hips and their relationship with pitching biomechanics and ball velocity in professional baseball pitchers. Am J Sports Med. 2010 Dec;38(12):2487-93. doi: 10.1177/0363546510375535. Epub 2010 Aug 31.
PubMed 20807860Edouard P, Samozino P, Julia M, Gleizes Cervera S, Vanbiervliet W, Calmels P, Gremeaux V. Reliability of isokinetic assessment of shoulder-rotator strength: a systematic review of the effect of position. J Sport Rehabil. 2011 Aug;20(3):367-83. doi: 10.1123/jsr.20.3.367.
PubMed 21828388Baltaci G, Tunay VB. Isokinetic performance at diagonal pattern and shoulder mobility in elite overhead athletes. Scand J Med Sci Sports. 2004 Aug;14(4):231-8. doi: 10.1111/j.1600-0838.2004.00348.x.
PubMed 15265145Laudner K, Wong R, Onuki T, Lynall R, Meister K. The relationship between clinically measured hip rotational motion and shoulder biomechanics during the pitching motion. J Sci Med Sport. 2015 Sep;18(5):581-4. doi: 10.1016/j.jsams.2014.07.011. Epub 2014 Jul 30.
PubMed 25130280
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pelvic Alignment on Shoulder Range of Motion and Torque Production
- ClinicalTrials.gov ID
- NCT03022305
- Acronym / sponsor ID
- IRB 201561
- Conditions
- Hip Alignment and Shoulder Rotation
- Keywords
- Hip alignment, Hip misalignment, Shoulder function, Shoulder rotation, Athletic shoulder injuries, Athletic hip alignment, Hip and shoulder alignment, Hip joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of North GeorgiaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Jan 2017 (estimated)
- 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 investigators hypothesize that neuromuscular realignment of the pelvis bones will be more effective in improving range of motion and torque production at the shoulder joint than traditional exercises for improving hip internal rotation and adduction range of motion.
Detailed description
Current literature shows a relationship between hip joint flexibility and shoulder range of motion and torque production in athletes and the general population. It is well established that limited hip joint internal rotation and adduction, specifically in baseball players, results in limited trunk rotation during pitching phase of throwing. Due to restricted rotation range at the hip joint, athletes try to compensate for the diminished rotational momentum of the trunk by producing excessive external rotation at the shoulder joint during the cocking phase of throwing. Such compensation results in laxity and overstressed shoulder joint structures. In the long term, increased laxity of the joint affects normal muscle mechanics and results in decreased torque production at the shoulder joint.
The investigators hypothesize that neuromuscular realignment of the pelvis bones will be more effective in improving range of motion and torque production at the shoulder joint than traditional exercises for improving hip internal rotation and adduction range of motion.
Group assignment:
An equal number of male and female subjects will be randomly assigned into one of three groups:
Group one will have standard treatment for improving hip range of motion. Group two will receive the new neuromuscular approach for improving pelvic alignment.
Group three will receive no treatment.
Participants and the examiners will be blinded to subjects' group assignment. Researchers will inform the subjects that they will be randomly assigned to a group with an exercise program in one of two timeframes: immediately after the initial assessment or after a one-week waiting period. Subjects in the control group will wait for one week, and then they will be asked to be tested one more time to make sure that the subject's physical condition did not change. At this time, these subjects will be informed of participation in the control group and will be given the option of going through the treatment program of choice. The neuromuscular treatment will also be offered to subjects in the standard group at the conclusion of the data collection period.
Testing procedures:
In a pretest session, the examiner, using a standard goniometer, will measure each participant's hip flexion, extension, adduction, abduction, internal rotation, and external rotation passive range of motion in seated position. Then the examiner will assess each participant's pelvic alignment using the Ober test and Thomas test. Shoulder range of motion will also be assessed using the standard goniometry procedures in the seated position. Shoulder torque production will be assessed using a Biodex isokinetic dynamometer.
The following parameters will be assessed using standard physical therapy techniques:
Hip Joint Assessment Hip range of motion assessment Hip Flexion Hip Extension Hip abduction Hip adduction Hip internal rotation Hip external rotation Ober test: [While the lower extremity is still neutral in the transverse plane, the examiner will allow the leg to slowly be lowered into full adduction. The test is considered positive if the knee joint does not reach the examination table. This test will be conducted for both sides.] Thomas test: [While holding the flexed knee to the chest, the participant will slowly lie back into a supine position on the examination table with the opposite leg hanging freely over the edge of the table. The test is considered positive if the free hanging leg is raised off the table with subject lying in supine position. This test will be conducted for both lower extremities.] Shoulder Joint Assessment Shoulder range of motion assessment Shoulder Flexion Shoulder Extension Shoulder Abduction Shoulder Internal Rotation Shoulder External Rotation Assessment of shoulder torque production: [Assessed by a Biodex isokinetic dynamometer.]
Treatment procedures:
Treatment procedure for group one:
Subjects in the standard treatment group will perform 10 repetitions of active hip internal rotation, external rotation, abduction, adduction, flexion and extension exercises daily, under supervision of the treating therapist.
Treatment neuromuscular training for group two:
Subjects in this group will perform the neuromuscular treatment for pelvic alignment, as suggested by Postural Restoration Institute, once a day under treating therapist supervision for one week. Subject will flex the hip and knee joints to 90° and will rest both feet against the wall with a standard 4 - 6" ball will be placed between the subject's knees. At this position, the subject is instructed to squeeze the ball between the knees and to perform an isometric hamstring muscle contraction (statically pulling the feet downward without pressing to the wall). At this point, the subject will be instructed to perform a gentle posterior pelvic tilt while avoiding abdominal muscle contraction. While maintaining this position, the subject is instructed to take a deep breath in through the nose and then slowly blow out into the balloon. The subject will be instructed to pause for 3 seconds while pressing the tongue to the roof the mouth to prevent airflow out of the balloon. After the 4th breath in, the subject will pinch the neck of the balloon and remove it from the mouth. Then subject will relax and take the feet off the wall. This exercise will be repeated daily for one week (Monday through Friday). Following neuromuscular training exercise, the patient will perform a coordinated hip internal and external rotation exercise in side lying.
The no treatment group will act as a control group. Both the standard and no treatment group will be offered free neuromuscular treatment at the conclusion of posttest data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group one - standard therapy | Experimental | Behavioral: Group one - standard therapyStandard physical therapy treatment for shoulder and hip malalignment will be administered for one week. |
| Group two - neuromuscular therapy | Experimental | Behavioral: Group two - neuromuscular therapyExperimental neuromuscular physical therapy treatment for shoulder and hip malalignment will be administered for one week. This therapy is exercised based. |
| Group three - no treatment | No intervention | –No physical therapy treatment will be given to this group. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (5 listed)
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 |
|---|---|---|
| Group one - standard therapyGroup two - standard physical therapy treatment for shoulder and hip maladjustment. | Behavioural | Group one - standard therapy |
| Group two - neuromuscular therapyUse of physical therapy treatment for shoulder and hip maladjustment. | Behavioural | Group two - neuromuscular therapy |
Primary outcome
Pelvic realignment achieved as indicated by negative Ober test on examination at completion of the training period..
Time frame: Outcomes will be assessed following one week for each of the therapy groups.
Results of the three groups, (1) standard conditioning, (2) neuromuscular conditioning, and (3) no conditioning, will be assessed for pelvic realignment following one week of each of these therapies.
1 secondary outcome
Pelvic realignment achieved as indicated by negative Thomas test on examination at completion of the training period..
Time frame: Outcomes will be assessed following one week for each of the therapy groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Background: PubMed 20807860Robb AJ, Fleisig G, Wilk K, Macrina L, Bolt B, Pajaczkowski J. Passive ranges of motion of the hips and their relationship with pitching biomechanics and ball velocity in professional baseball pitchers. Am J Sports Med. 2010 Dec;38(12):2487-93. doi: 10.1177/0363546510375535. Epub 2010 Aug 31.
- Background: PubMed 21828388Edouard P, Samozino P, Julia M, Gleizes Cervera S, Vanbiervliet W, Calmels P, Gremeaux V. Reliability of isokinetic assessment of shoulder-rotator strength: a systematic review of the effect of position. J Sport Rehabil. 2011 Aug;20(3):367-83. doi: 10.1123/jsr.20.3.367.
- Background: PubMed 15265145Baltaci G, Tunay VB. Isokinetic performance at diagonal pattern and shoulder mobility in elite overhead athletes. Scand J Med Sci Sports. 2004 Aug;14(4):231-8. doi: 10.1111/j.1600-0838.2004.00348.x.
- Results publication: PubMed 25130280Laudner K, Wong R, Onuki T, Lynall R, Meister K. The relationship between clinically measured hip rotational motion and shoulder biomechanics during the pitching motion. J Sci Med Sport. 2015 Sep;18(5):581-4. doi: 10.1016/j.jsams.2014.07.011. Epub 2014 Jul 30.
- Individual participant dataSharing planned: No
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.
Reza Nourbakhsh, PhD principal investigator
University of North Georgia
Questions about this trial
What is this clinical trial studying?
A study testing Group one - standard therapy and Group two - neuromuscular therapy in people with Hip Alignment and Shoulder Rotation, run by University of North Georgia.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic realignment achieved as indicated by negative Ober test on examination at completion of the training period.. (time frame: Outcomes will be assessed following one week for each of the therapy groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022305, which also lists 4 linked publications.
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 16 Jan 2017.