Shoulder Range of Motion in Healthy IndividualsNCT01518504
Effects of Thoracic Mobilization on Shoulder Range of Motion
A study testing Thoracic Mobilization in people with Shoulder Range of Motion in Healthy Individuals, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of thoracic spine joint manipulation versus a sham intervention on active and passive shoulder flexion (elevation), external rotation, and internal rotation range of motion. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Range of Motion in Healthy Individuals
- What is being tested?
- Thoracic Mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2012
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 19-45 years
Who cannot join
- Individuals who are pregnant
- History of cervical or thoracic surgery
- Bone or joint disease
- Current infection or tumor
- Osteopenia/osteoporosis
- Spinal fracture
- Rheumatologic pathologies
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effect of thoracic spine joint manipulation versus a sham intervention on active and passive shoulder flexion (elevation), external rotation, and internal rotation range of motion.
Read the detailed description
Many individuals who have a primary complaint of shoulder pain often demonstrate deficits in glenohumeral and scapulothoracic mobility. Typically individuals will have limitations in shoulder range of motion, specifically, flexion (elevation) as well as external and internal rotation. Although the glenohumeral joint is the primary joint for shoulder motion adjacent joints such as the sternoclavicular, acromioclavicular, scapulothoracic, and thoracic spine also contribute to maximal shoulder motion. Limited shoulder motion may be a result of joint hypomobility, muscle inhibition, or pain. Typically interventions such as stretching and joint mobilization/manipulation are directed at the glenohumeral joint to improve shoulder motion, but little is known about interventions targeting adjacent sites which may also improve shoulder range of motion. This study will evaluate the effect of thoracic spine joint manipulation on active and passive shoulder range of motion.
- Being tested
- Thoracic Mobilization, Sham
- Keywords
- Thoracic, Manipulation, Manual Therapy, Mobilization, Shoulder, Range of Motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic MobilizationOther
Also called manipulation, Grade V joint mobilization, small amplitude, quick thrust mobilization/manipulation
The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range.
ShamOther
The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Mobilization | Experimental | The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range. Receives: Other: Thoracic Mobilization |
| Sham | Sham comparator | The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Shoulder Range of motion
To determine changes in shoulder active and passive range of motion following one of two intervention protocols. Changes will be measured by examining shoulder range of motion in three directions: Shoulder flexion, internal rotation and external rotation.
We hypothesize that the use of a thoracic spine joint manipulation will increase shoulder range of motion in flexion (elevation) as well as external and internal rotation to a greater degree than a sham mobilization.
Measured: Single Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Range of Motion in Healthy IndividualsStudies 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, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry L Grindstaff, PHD,PT,ATC, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518504
- Sponsor's protocol ID
- 11-16286
- Status last verified
- Nov 2012
- First submitted
- 1 Dec 2011
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Mobilization on Shoulder Range of Motion
- ClinicalTrials.gov ID
- NCT01518504
- Acronym / sponsor ID
- 11-16286
- Keywords
- Thoracic, Manipulation, Manual Therapy, Mobilization, Shoulder, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Jan 2012 (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 purpose of this study is to investigate the effect of thoracic spine joint manipulation versus a sham intervention on active and passive shoulder flexion (elevation), external rotation, and internal rotation range of motion.
Detailed description
Many individuals who have a primary complaint of shoulder pain often demonstrate deficits in glenohumeral and scapulothoracic mobility. Typically individuals will have limitations in shoulder range of motion, specifically, flexion (elevation) as well as external and internal rotation. Although the glenohumeral joint is the primary joint for shoulder motion adjacent joints such as the sternoclavicular, acromioclavicular, scapulothoracic, and thoracic spine also contribute to maximal shoulder motion. Limited shoulder motion may be a result of joint hypomobility, muscle inhibition, or pain. Typically interventions such as stretching and joint mobilization/manipulation are directed at the glenohumeral joint to improve shoulder motion, but little is known about interventions targeting adjacent sites which may also improve shoulder range of motion. This study will evaluate the effect of thoracic spine joint manipulation on active and passive shoulder range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Mobilization | Experimental | Other: Thoracic MobilizationThe subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range. |
| Sham | Sham comparator | Other: ShamThe subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults 19-45 years
Key exclusion criteria (7 listed)
- Individuals who are pregnant
- History of cervical or thoracic surgery
- Bone or joint disease
- Current infection or tumor
- Osteopenia/osteoporosis
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 |
|---|---|---|
| Thoracic MobilizationAlso: manipulation, Grade V joint mobilization, small amplitude, quick thrust mobilization/manipulationThe subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range. | Other | Thoracic Mobilization |
| ShamThe subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact. | Other | Sham |
Primary outcome
Changes in Shoulder Range of motion
Time frame: Single Study Visit
To determine changes in shoulder active and passive range of motion following one of two intervention protocols. Changes will be measured by examining shoulder range of motion in three directions: Shoulder flexion, internal rotation and external rotation. We hypothesize that the use of a thoracic spine joint manipulation will increase shoulder range of motion in flexion (elevation) as well as external and internal rotation to a greater degree than a sham mobilization.
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 21 Nov 2012.
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.
Terry L Grindstaff, PHD,PT,ATC principal investigator
Creighton 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 Thoracic Mobilization in people with Shoulder Range of Motion in Healthy Individuals, run by Creighton 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 1 inclusion and 7 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 21 Nov 2012. 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. Some participants in this study may receive a placebo. 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?
Changes in Shoulder Range of motion (time frame: Single Study Visit). 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 21 Nov 2012.