Range of MotionNCT04777370
Combined Effects of Manual Therapy on the Shoulder
A study testing posterior glide mobilization, Sleeper stretch and thoracic manipulation in people with Range of Motion and Manual Therapies, run by University of Hartford at 1 site in United States.
Trial summary
Interventions including glenohumeral mobilization, sleeper stretches, and thoracic manipulation have been proposed for individuals with loss of shoulder range of motion (ROM). However, the effect of these interventions on shoulder ROM, joint translation, and muscular activity have not been studied in combination. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Range of Motion, Manual Therapies, Shoulder Joint Disorder
- What is being tested?
- posterior glide mobilization, Sleeper stretch and thoracic manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 30 Jun 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- loss of IR of 15 degrees of greater compared to contralateral shoulder
Who cannot join
- currently neck/upper back pain,
- history of spinal fractures,
- numbness/altered sensation of the arms or legs,
- whiplash injury within the prior 6 weeks,
- infections of the spine,
- currently pregnant/possibly pregnant,
Show all 17Show fewer
- known osteoporosis,
- Rheumatoid arthritis,
- previous spine surgery,
- currently receiving Workman's Compensation,
- any pending litigation regarding a neck or shoulder injury,
- history of oral corticosteroids in the prior 6 months,
- history of shoulder fractures,
- Current treatment for cancer,
- Prior history of cancer involving the spine/shoulder,
- any history of coagulation disorders.
- Individuals with a history of shoulder surgery will reviewed on a case by case basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hartford
West Hartford, Connecticut, 06117
About this study
Official title: Are There Differences in Range of Motion, Glenohumeral Translation, and Rotator Cuff Activity Following Shoulder Mobilization, Stretching, or Thoracic Manipulation?
Interventions including glenohumeral mobilization, sleeper stretches, and thoracic manipulation have been proposed for individuals with loss of shoulder range of motion (ROM). However, the effect of these interventions on shoulder ROM, joint translation, and muscular activity have not been studied in combination.
Read the detailed description
Forty individuals with a loss of internal rotation (IR) ROM will be recruited and randomized to one of two interventions at the first session: either posterior glenohumeral mobilization or internal rotation "sleeper" stretching. At the second visit, all participants will undergo a thoracic manipulation (T3-4 segment) followed by a repeat of either the sleeper stretch or glenohumeral mobilization.
- Conditions
- Range of Motion, Manual Therapies, Shoulder Joint Disorder
- Being tested
- posterior glide mobilization, Sleeper stretch, thoracic manipulation
- Keywords
- shoulder, Glenohumeral Internal Rotation Deficit (GIRD), joint play, muscular activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior glide mobilizationOther
The participant will be positioned supine on a plinth, with their scapula stabilized against a firm wedge on the table, and the shoulder joint in the resting position (approx. 55 degrees abduction, 30 degrees horizontal adduction, and slight external rotation). With the extremity held in the same position, the researcher will then apply a grade III (into tissue stretch) PG mobilization. This will consist of five 30-second bouts of sustained gr III posterior glide mobilizations.
Sleeper stretchOther
All participants randomized to the stretching group will perform five 30-second holds of the sleeper stretch. This is performed by lying on the side to be stretched, elevating the upper arm to 90° on the support surface with the elbow bent 90°, then passively internally rotating the shoulder with force provided by with the opposite arm.
thoracic manipulationOther
Individuals will then undergo a single supine grade V thrust manipulation. All manipulations will take place at the T3-4 segment. If a cavitation ("pop") is not heard or felt by either the subject or examiner, a second thrust will be performed.
| Study group | Role | What they receive |
|---|---|---|
| sleeper stretch + thoracic manipulation | Experimental | The group will receive the sleeper stretch at session #1, and a thoracic manipulation followed by the sleeper stretch at session #2. Receives: Other: Sleeper stretch; Other: thoracic manipulation |
| posterior glenohumeral (PG) mobilization + thoracic manipulation | Experimental | The group will receive a posterior glide mobilization at session #1, and a thoracic manipulation followed by posterior glide mobilization at session #2. Receives: Other: posterior glide mobilization; Other: thoracic manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shoulder IR ROM
Shoulder IR ROM measured with a goniometer
Measured: Pre intervention to immediate (within 5 minutes) post intervention
Change in posterior shoulder translation (mm)
maximum posterior translation of the humeral head assessed with ultrasound imaging (mm)
Measured: Pre intervention to immediate (within 5 minutes) post intervention
Change in infraspinatus electromyographic activity (%MVIC)
activity of the infraspinatus muscle during posterior translation, assessed as a percentage of the maximal voluntary isometric contraction (MVIC)
Measured: Pre intervention to immediate (within 5 minutes) post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start31 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Range of MotionStudies 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
- Sequential
- Model description
- All participants will undergo a single intervention during the first session, and then combined thoracic manipulation and a repeat of the prior intervention at the second session.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Swanson, PT, DSc, Principal investigator, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777370
- Sponsor's protocol ID
- PRO2021000105
- Status last verified
- Jul 2021
- First submitted
- 22 Feb 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are There Differences in Range of Motion, Glenohumeral Translation, and Rotator Cuff Activity Following Shoulder Mobilization, Stretching, or Thoracic Manipulation?
- ClinicalTrials.gov ID
- NCT04777370
- Acronym / sponsor ID
- PRO2021000105
- Conditions
- Range of Motion, Manual Therapies, Shoulder Joint Disorder
- Keywords
- shoulder, Glenohumeral Internal Rotation Deficit (GIRD), joint play, muscular activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 2 Mar 2021 (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.
Interventions including glenohumeral mobilization, sleeper stretches, and thoracic manipulation have been proposed for individuals with loss of shoulder range of motion (ROM). However, the effect of these interventions on shoulder ROM, joint translation, and muscular activity have not been studied in combination.
Detailed description
Forty individuals with a loss of internal rotation (IR) ROM will be recruited and randomized to one of two interventions at the first session: either posterior glenohumeral mobilization or internal rotation "sleeper" stretching. At the second visit, all participants will undergo a thoracic manipulation (T3-4 segment) followed by a repeat of either the sleeper stretch or glenohumeral mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will undergo a single intervention during the first session, and then combined thoracic manipulation and a repeat of the prior intervention at the second session.
| Arm | Type | Receives |
|---|---|---|
| sleeper stretch + thoracic manipulation | Experimental | Other: Sleeper stretch, Other: thoracic manipulationThe group will receive the sleeper stretch at session #1, and a thoracic manipulation followed by the sleeper stretch at session #2. |
| posterior glenohumeral (PG) mobilization + thoracic manipulation | Experimental | Other: posterior glide mobilization, Other: thoracic manipulationThe group will receive a posterior glide mobilization at session #1, and a thoracic manipulation followed by posterior glide mobilization at session #2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- loss of IR of 15 degrees of greater compared to contralateral shoulder
Key exclusion criteria (17 listed)
- currently neck/upper back pain,
- history of spinal fractures,
- numbness/altered sensation of the arms or legs,
- whiplash injury within the prior 6 weeks,
- infections of the spine,
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 |
|---|---|---|
| posterior glide mobilizationThe participant will be positioned supine on a plinth, with their scapula stabilized against a firm wedge on the table, and the shoulder joint in the resting position (approx. 55 degrees abduction, 30 degrees horizontal adduction, and slight external rotation). With the extremity held in the same position, the researcher will then apply a grade III (into tissue stretch) PG mobilization. This will consist of five 30-second bouts of sustained gr III posterior glide mobilizations. | Other | posterior glenohumeral (PG) mobilization + thoracic manipulation |
| Sleeper stretchAll participants randomized to the stretching group will perform five 30-second holds of the sleeper stretch. This is performed by lying on the side to be stretched, elevating the upper arm to 90° on the support surface with the elbow bent 90°, then passively internally rotating the shoulder with force provided by with the opposite arm. | Other | sleeper stretch + thoracic manipulation |
| thoracic manipulationIndividuals will then undergo a single supine grade V thrust manipulation. All manipulations will take place at the T3-4 segment. If a cavitation ("pop") is not heard or felt by either the subject or examiner, a second thrust will be performed. | Other | posterior glenohumeral (PG) mobilization + thoracic manipulation, sleeper stretch + thoracic manipulation |
Primary outcome
Change in shoulder IR ROM
Time frame: Pre intervention to immediate (within 5 minutes) post intervention
Shoulder IR ROM measured with a goniometer
Change in posterior shoulder translation (mm)
Time frame: Pre intervention to immediate (within 5 minutes) post intervention
maximum posterior translation of the humeral head assessed with ultrasound imaging (mm)
Change in infraspinatus electromyographic activity (%MVIC)
Time frame: Pre intervention to immediate (within 5 minutes) post intervention
activity of the infraspinatus muscle during posterior translation, assessed as a percentage of the maximal voluntary isometric contraction (MVIC)
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 7 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Brian Swanson, PT, DSc principal investigator
University of Hartford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterior glide mobilization, Sleeper stretch and thoracic manipulation in people with Range of Motion and Manual Therapies, run by University of Hartford 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 1 inclusion and 17 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 7 Jul 2021. 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?
Change in shoulder IR ROM (time frame: Pre intervention to immediate (within 5 minutes) post intervention). The study lists 3 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 7 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.