Glenohumeral Internal Rotation DeficitsGIRDNCT03044236
Effect of a Novel Stretching Technique on Shoulder Range of Motion and Voluntary Contraction in Overhead Athletes With Glenohumeral Internal Rotation Deficits "GIRD"
A study testing Stretching in people with Glenohumeral Internal Rotation Deficits, run by Loma Linda University at 1 site in United States.
Trial summary
To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glenohumeral Internal Rotation Deficits
- What is being tested?
- Stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to 1 Jun 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be between the age of 18 and 45.
- Perform overhead sports activities in the past 3 months.
- Participants are required to display ≥ 20° less glenohumeral internal rotation ROM in their dominant shoulder compare to the non- dominate shoulder.
- Participants will be included with or without pain during shoulder activities.
Who cannot join
- Will exclude participants who are still recovering from previous surgery of the shoulder and elbow complex in the past 3 months, and currently receiving medical intervention for the shoulder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Novel Stretching Technique on Shoulder Range of Motion and Maximum Voluntary Contraction in Overhead Athletes With Glenohumeral Internal Rotation Deficits: A Randomized Control Trial
To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study.
Read the detailed description
To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study. The investigators hypothesize that this type of novel intervention will help subjects with GIRD to restore range of motion, experience less pain and maintain the strength and motor unit recruitment following the novel intervention. This will help us to assess the potential beneficial effect of such intervention and to fill the gap in knowledge and help health care professionals to adequately select the right treatment modality.
Independent Variable
- Type of Intervention:
- Traditional Stretching (Modified Sleep Stretch). VS
- Novel Stretching (Active Shoulder Internal Rotation while Bridging) 2. Time
- Pre VS post intervention Dependent Variables
- Glenohumeral internal rotation ROM
- Maximal glenohumeral external rotation isometric strength.
- Mean motor unit recruitment (EMG) of the glenohumeral external rotator (infraspinatus) and internal rotators (pectoralis major and latissumus dorsi)
- Pain
- Subject satisfaction
Instrumentation :
- Glenohumeral internal \& external rotation ROM: will be measured at baseline and at week four-post intervention for all participants. We will use the digital inclinometer. Research by (Kolber et al.,2011 ) showed this instrument to be reliable with an intra-rater ICC =0.87 and inter-rater ICC =0.93
- Electronic push/pull dynamometer: At the end feel ROM, and before ROM is measured, the therapist will apply the same amount of pressure to all subjects to ensure reliable/ valid ROM measurements.
- Maximal Glenohumeral External Rotation Isometric Strength will be measured using a MicroFET2 handheld digital dynamometer. This device was shown to be reliable with an intra-rater ICC =0.85 and inter-rater ICC =0.85.
- Maximum Voluntary Contraction: will be measured using a 44 Delsys Bagnoli portable surface electromyography (sEMG) system.
- Pain: will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS has shown to have a valid, reliable and appropriate for use in clinical practice
Procedures:
All participants will perform the static stretching (SS) conditions by themselves. The two stretching techniques will be home-based program.
- Conditions
- Glenohumeral Internal Rotation Deficits
- Being tested
- Stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StretchingProcedure or surgery
The novel stretching technique will be done on a supine position. subjects will be asked bridge as high as possible. After That, Participants will then flex their shoulder and elbow to 90°. Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch.
| Study group | Role | What they receive |
|---|---|---|
| Novel Stretching Technique | Experimental | Participants will perform the novel stretch in a supine position. Participants will place a small ball between their knees and squeeze the ball. Participants will be then bridge as high as possible . Participants will then flex their shoulder and elbow to 90°, and actively rotate to the end of ROM. Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch. Receives: Procedure: Stretching |
| Traditional Stretching Technique | Active comparator | Participants will perform the modified sleeper stretch in a side-lying position on the side of the throwing shoulder with the throwing shoulder and elbow flexed to 90° . The participants will be instructed to allow the throwing shoulder to naturally fall into internal rotation to the end ROM where resistance will be felt . The participants will be then instructed to use the non-throwing hand to push the throwing shoulder into further internal rotation to the point of mild discomfort by applying pressure at the area of the wrist joint. Receives: Procedure: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glenohumeral internal rotation ROM
The investigators will use the digital inclinometer
Measured: Change from baseline at week 4
Secondary outcomes (1)
Maximal glenohumeral external rotation isometric strength
will be measured using a MicroFET2 handheld digital dynamometer
Measured: Change from baseline at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start19 Apr 2017
- Primary completion19 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glenohumeral Internal Rotation DeficitsStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Everett Lohman, Loma Linda University
- Investigators
- Everett Lohman, DSc, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044236
- Sponsor's protocol ID
- 5170032
- Acronym
- GIRD
- Status last verified
- Aug 2018
- First submitted
- 30 Jan 2017
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gharisia O, Lohman E, Daher N, Eldridge A, Shallan A, Jaber H. Effect of a novel stretching technique on shoulder range of motion in overhead athletes with glenohumeral internal rotation deficits: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 30;22(1):402. doi: 10.1186/s12891-021-04292-8.
PubMed 33941143
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Stretching Technique on Shoulder Range of Motion and Maximum Voluntary Contraction in Overhead Athletes With Glenohumeral Internal Rotation Deficits: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03044236
- Acronym / sponsor ID
- GIRD / 5170032
- Conditions
- Glenohumeral Internal Rotation Deficits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 6 Feb 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.
To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study.
Detailed description
To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study. The investigators hypothesize that this type of novel intervention will help subjects with GIRD to restore range of motion, experience less pain and maintain the strength and motor unit recruitment following the novel intervention. This will help us to assess the potential beneficial effect of such intervention and to fill the gap in knowledge and help health care professionals to adequately select the right treatment modality.
Independent Variable
- Type of Intervention:
- Traditional Stretching (Modified Sleep Stretch). VS
- Novel Stretching (Active Shoulder Internal Rotation while Bridging) 2. Time
- Pre VS post intervention Dependent Variables
- Glenohumeral internal rotation ROM
- Maximal glenohumeral external rotation isometric strength.
- Mean motor unit recruitment (EMG) of the glenohumeral external rotator (infraspinatus) and internal rotators (pectoralis major and latissumus dorsi)
- Pain
- Subject satisfaction
Instrumentation :
- Glenohumeral internal \& external rotation ROM: will be measured at baseline and at week four-post intervention for all participants. We will use the digital inclinometer. Research by (Kolber et al.,2011 ) showed this instrument to be reliable with an intra-rater ICC =0.87 and inter-rater ICC =0.93
- Electronic push/pull dynamometer: At the end feel ROM, and before ROM is measured, the therapist will apply the same amount of pressure to all subjects to ensure reliable/ valid ROM measurements.
- Maximal Glenohumeral External Rotation Isometric Strength will be measured using a MicroFET2 handheld digital dynamometer. This device was shown to be reliable with an intra-rater ICC =0.85 and inter-rater ICC =0.85.
- Maximum Voluntary Contraction: will be measured using a 44 Delsys Bagnoli portable surface electromyography (sEMG) system.
- Pain: will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS has shown to have a valid, reliable and appropriate for use in clinical practice
Procedures:
All participants will perform the static stretching (SS) conditions by themselves. The two stretching techniques will be home-based program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel Stretching Technique | Experimental | Procedure: StretchingParticipants will perform the novel stretch in a supine position. Participants will place a small ball between their knees and squeeze the ball. Participants will be then bridge as high as possible . Participants will then flex their shoulder and elbow to 90°, and actively rotate to the end of ROM. Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch. |
| Traditional Stretching Technique | Active comparator | Procedure: StretchingParticipants will perform the modified sleeper stretch in a side-lying position on the side of the throwing shoulder with the throwing shoulder and elbow flexed to 90° . The participants will be instructed to allow the throwing shoulder to naturally fall into internal rotation to the end ROM where resistance will be felt . The participants will be then instructed to use the non-throwing hand to push the throwing shoulder into further internal rotation to the point of mild discomfort by applying pressure at the area of the wrist joint. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must be between the age of 18 and 45.
- Perform overhead sports activities in the past 3 months.
- Participants are required to display ≥ 20° less glenohumeral internal rotation ROM in their dominant shoulder compare to the non- dominate shoulder.
- Participants will be included with or without pain during shoulder activities.
Key exclusion criteria (1 listed)
- Will exclude participants who are still recovering from previous surgery of the shoulder and elbow complex in the past 3 months, and currently receiving medical intervention for the shoulder.
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 |
|---|---|---|
| StretchingThe novel stretching technique will be done on a supine position. subjects will be asked bridge as high as possible. After That, Participants will then flex their shoulder and elbow to 90°. Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch. | Procedure or surgery | Novel Stretching Technique, Traditional Stretching Technique |
Primary outcome
Glenohumeral internal rotation ROM
Time frame: Change from baseline at week 4
The investigators will use the digital inclinometer
1 secondary outcome
Maximal glenohumeral external rotation isometric strength
Time frame: Change from baseline at week 4
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 11 Jun 2019.
- Derived from this study: PubMed 33941143Gharisia O, Lohman E, Daher N, Eldridge A, Shallan A, Jaber H. Effect of a novel stretching technique on shoulder range of motion in overhead athletes with glenohumeral internal rotation deficits: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 30;22(1):402. doi: 10.1186/s12891-021-04292-8.
- 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.
Everett Lohman, DSc principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching in people with Glenohumeral Internal Rotation Deficits, run by Loma Linda University 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 4 inclusion and 1 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 11 Jun 2019. 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?
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?
Glenohumeral internal rotation ROM (time frame: Change from baseline at week 4). 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 NCT03044236, which also lists 1 linked publication.
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 11 Jun 2019.