Shoulder ImpingementNCT01743833
Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement
A study testing Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM) and Scapular High Velocity, Low Amplitude Thrust Maneuver in people with Shoulder Impingement, run by UConn Health at 1 site in United States.
Trial summary
Shoulder impingement has been identified as the most common cause of shoulder pain in the adult general population. Sometimes therapeutic pushing on the middle part of the back (manual therapy) decreases shoulder pain in someone experiencing shoulder impingement. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM) and Scapular High Velocity, Low Amplitude Thrust Maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 5 Dec 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A consecutive convenience sampling of patients with complaints of shoulder pain that are not post-surgical will be screened at their initial evaluation. Subjects between the ages of 18 and 69 years will be included if they present with a painful arc of shoulder active ROM. Additional requirements for inclusion will be (1) shoulder pain greater than 1/10 but less than 9/10 at time of testing; (2) shoulder active ROM above horizontal; (3) the ability to lie prone with arms at their side; and (4) at least one of the following signs or symptoms: (1) a positive Hawkins-Kennedy Sign; (2) a positive Neer Impingement Sign; (3) painful resisted abduction; (4) painful resisted external rotation at 0°of abduction with the elbows bent to 90°
Who cannot join
- Subjects will be excluded from the study if they have any of the following: (1) A history of unstable thoracic spine joints or fractures; (2) A history of spinal bone tumors; (3) A bleeding disorder or the use of anticoagulant therapy (not to include a baby aspirin); (4) Acute rheumatoid arthritis or ankylosing spondylitis; (5) Signs and symptoms of myelopathy or cauda equina syndrome; (6) A systemic infection that may involve the spinal column, ribs, or shoulder girdle; (7) A history of osteoporosis or fracture of shoulder girdle bones; (8) Presence of radiculopathy with progressive signs; (9) Primary complaints of neck or thoracic pain; (10) A positive cervical distraction test; (11) A positive Spurling's test; (12) A large three-dimensional limitation of arm motion of greater than 20 degrees with any passive motion of the shoulder as compared to the contralateral side, to rule out adhesive capsulitis.; (13) A previous history of shoulder surgery such as a rotator cuff repair; (14) Physical therapy treatment to the shoulder or thoracic spine within the 3 months prior to participation in the study; (15) A cortisone or other fluid injection into the shoulder joint within 30 days of participation in the study; (16) A history of multiple sclerosis, or neuropathy; (17) Pregnancy; (18) Inability to attend a 6 to 9-day follow-up; and (19) Spinal fusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecicut Health Center
Farmington, Connecticut, 06030-4038
About this study
Official title: Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement: A Randomized Clinical Trial
Shoulder impingement has been identified as the most common cause of shoulder pain in the adult general population. Sometimes therapeutic pushing on the middle part of the back (manual therapy) decreases shoulder pain in someone experiencing shoulder impingement. We do not known what causes the decreased shoulder pain. It could be that the therapeutic pushing makes things move better. It may be that the person getting their back treatment thinks they are better or the physical therapist who provides the manual treatment thinks it works.
Read the detailed description
Shoulder impingement has been identified as the most common cause of shoulder pain in the adult general population. High-Velocity, Low-Amplitude Thrust Manipulations (HVLATM) of the thoracic spine and ribs result in increased shoulder ROM, as well as decreased pain and disability in patients suffering shoulder impingement. The quality of the sparse publications is low and lacking control or comparison groups regarding the use of HVLATM in the management of shoulder impingement. Further higher quality randomized clinical trials are needed. Moreover, no research has investigated the effects of the patients beliefs and different types of verbal messages conveyed by the clinician to the subjects in regard to the effects of HVLATM of the thoracic spine on shoulder pain and function. The purpose of this study is to evaluate, in subjects with signs and symptoms of shoulder impingement: (1) the effects of a series of the prone thoracic spine High Velocity Low Amplitude Thrust Manipulation (HVLATM) as compared to the HVLATM directed at the scapula, on shoulder pain, impingement symptoms, and functional outcomes; (2) the effect of the type of message and language used by the clinician in regard to thoracic HVLATM on shoulder pain, impingement symptoms, and functional outcomes; (3) the effect of subject's expectation of outcome of thoracic and scapula HVLATM on shoulder pain, impingement symptoms, and functional outcomes; (4) if these potential immediate improvements will be sustained at 6 to 9-day follow up.
- Conditions
- Shoulder Impingement
- Being tested
- Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM), Scapular High Velocity, Low Amplitude Thrust Maneuver
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)Other
Scapular High Velocity, Low Amplitude Thrust ManeuverOther
| Study group | Role | What they receive |
|---|---|---|
| Thoracic HVLAMT, Postive Message | Active comparator | Thoracic HVLAMT with a positive message given prior to the intervention. Receives: Other: Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM) |
| Thoracic HVLATM, Neutral Message | Active comparator | Thoracic HVLAMT with a neutral message given prior to the intervention. Receives: Other: Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM) |
| Scapular HVLATM, Positive Message | Active comparator | Scapular HVLAMT with a positive message given prior to the intervention. Receives: Other: Scapular High Velocity, Low Amplitude Thrust Maneuver |
| Scapular HVLATM, Neutral Message | Active comparator | Scapular HVLAMT with a neutral message given prior to the intervention. Receives: Other: Scapular High Velocity, Low Amplitude Thrust Maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
The primary outcome measure is SPADI score at 6-9 days post intervention. The SPADI is also collected pretreatment and immediately post treatment.
Measured: 6-9 days following treatment
Secondary outcomes (1)
Numeric Pain Rating Scale
Measured: Pre, Post, and 6-9 days following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJun 2011
- Primary completion5 Dec 2012
- Study completion5 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Tech University
- Responsible party
- Principal investigator, Augustus Mazzocca, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743833
- Sponsor's protocol ID
- #11-135-3
- Status last verified
- Apr 2017
- First submitted
- 30 Nov 2012
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Riley SP, Cote MP, Swanson B, Tafuto V, Sizer PS, Brismee JM. The Shoulder Pain and Disability Index: Is it sensitive and responsive to immediate change? Man Ther. 2015 Jun;20(3):494-8. doi: 10.1016/j.math.2014.12.002. Epub 2014 Dec 20.
PubMed 25560477Riley SP, Bialosky J, Cote MP, Swanson BT, Tafuto V, Sizer PS, Brismee JM. Thoracic spinal manipulation for musculoskeletal shoulder pain: Can an instructional set change patient expectation and outcome? Man Ther. 2015 Jun;20(3):469-74. doi: 10.1016/j.math.2014.11.011. Epub 2014 Dec 2.
PubMed 25543999
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01743833
- Acronym / sponsor ID
- #11-135-3
- Conditions
- Shoulder Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Texas Tech University
- Study start
- Jun 2011
- Primary completion
- 5 Dec 2012 (actual)
- Study completion
- 5 Dec 2012 (actual)
- First posted
- 6 Dec 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.
Shoulder impingement has been identified as the most common cause of shoulder pain in the adult general population. Sometimes therapeutic pushing on the middle part of the back (manual therapy) decreases shoulder pain in someone experiencing shoulder impingement. We do not known what causes the decreased shoulder pain. It could be that the therapeutic pushing makes things move better. It may be that the person getting their back treatment thinks they are better or the physical therapist who provides the manual treatment thinks it works.
Detailed description
Shoulder impingement has been identified as the most common cause of shoulder pain in the adult general population. High-Velocity, Low-Amplitude Thrust Manipulations (HVLATM) of the thoracic spine and ribs result in increased shoulder ROM, as well as decreased pain and disability in patients suffering shoulder impingement. The quality of the sparse publications is low and lacking control or comparison groups regarding the use of HVLATM in the management of shoulder impingement. Further higher quality randomized clinical trials are needed. Moreover, no research has investigated the effects of the patients beliefs and different types of verbal messages conveyed by the clinician to the subjects in regard to the effects of HVLATM of the thoracic spine on shoulder pain and function. The purpose of this study is to evaluate, in subjects with signs and symptoms of shoulder impingement: (1) the effects of a series of the prone thoracic spine High Velocity Low Amplitude Thrust Manipulation (HVLATM) as compared to the HVLATM directed at the scapula, on shoulder pain, impingement symptoms, and functional outcomes; (2) the effect of the type of message and language used by the clinician in regard to thoracic HVLATM on shoulder pain, impingement symptoms, and functional outcomes; (3) the effect of subject's expectation of outcome of thoracic and scapula HVLATM on shoulder pain, impingement symptoms, and functional outcomes; (4) if these potential immediate improvements will be sustained at 6 to 9-day follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Thoracic HVLAMT, Postive Message | Active comparator | Other: Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)Thoracic HVLAMT with a positive message given prior to the intervention. |
| Thoracic HVLATM, Neutral Message | Active comparator | Other: Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)Thoracic HVLAMT with a neutral message given prior to the intervention. |
| Scapular HVLATM, Positive Message | Active comparator | Other: Scapular High Velocity, Low Amplitude Thrust ManeuverScapular HVLAMT with a positive message given prior to the intervention. |
| Scapular HVLATM, Neutral Message | Active comparator | Other: Scapular High Velocity, Low Amplitude Thrust ManeuverScapular HVLAMT with a neutral message given prior to the intervention. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A consecutive convenience sampling of patients with complaints of shoulder pain that are not post-surgical will be screened at their initial evaluation. Subjects between the ages of 18 and 69 years will be included if they present with a painful arc of shoulder active ROM. Additional requirements for inclusion will be (1) shoulder pain greater than 1/10 but less than 9/10 at time of testing; (2) shoulder active ROM above horizontal; (3) the ability to lie prone with arms at their side; and (4) at least one of the following signs or symptoms: (1) a positive Hawkins-Kennedy Sign; (2) a positive Neer Impingement Sign; (3) painful resisted abduction; (4) painful resisted external rotation at 0°of abduction with the elbows bent to 90°
Key exclusion criteria (1 listed)
- Subjects will be excluded from the study if they have any of the following: (1) A history of unstable thoracic spine joints or fractures; (2) A history of spinal bone tumors; (3) A bleeding disorder or the use of anticoagulant therapy (not to include a baby aspirin); (4) Acute rheumatoid arthritis or ankylosing spondylitis; (5) Signs and symptoms of myelopathy or cauda equina syndrome; (6) A systemic infection that may involve the spinal column, ribs, or shoulder girdle; (7) A history of osteoporosis or fracture of shoulder girdle bones; (8) Presence of radiculopathy with progressive signs; (9) Primary complaints of neck or thoracic pain; (10) A positive cervical distraction test; (11) A positive Spurling's test; (12) A large three-dimensional limitation of arm motion of greater than 20 degrees with any passive motion of the shoulder as compared to the contralateral side, to rule out adhesive capsulitis.; (13) A previous history of shoulder surgery such as a rotator cuff repair; (14) Physical therapy treatment to the shoulder or thoracic spine within the 3 months prior to participation in the study; (15) A cortisone or other fluid injection into the shoulder joint within 30 days of participation in the study; (16) A history of multiple sclerosis, or neuropathy; (17) Pregnancy; (18) Inability to attend a 6 to 9-day follow-up; and (19) Spinal fusion.
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 High Velocity, Low Amplitude Thrust Maneuver (HVLATM) | Other | Thoracic HVLAMT, Postive Message, Thoracic HVLATM, Neutral Message |
| Scapular High Velocity, Low Amplitude Thrust Maneuver | Other | Scapular HVLATM, Neutral Message, Scapular HVLATM, Positive Message |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: 6-9 days following treatment
The primary outcome measure is SPADI score at 6-9 days post intervention. The SPADI is also collected pretreatment and immediately post treatment.
1 secondary outcome
Numeric Pain Rating Scale
Time frame: Pre, Post, and 6-9 days following treatment
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 26 Apr 2017.
- Derived from this study: PubMed 25560477Riley SP, Cote MP, Swanson B, Tafuto V, Sizer PS, Brismee JM. The Shoulder Pain and Disability Index: Is it sensitive and responsive to immediate change? Man Ther. 2015 Jun;20(3):494-8. doi: 10.1016/j.math.2014.12.002. Epub 2014 Dec 20.
- Derived from this study: PubMed 25543999Riley SP, Bialosky J, Cote MP, Swanson BT, Tafuto V, Sizer PS, Brismee JM. Thoracic spinal manipulation for musculoskeletal shoulder pain: Can an instructional set change patient expectation and outcome? Man Ther. 2015 Jun;20(3):469-74. doi: 10.1016/j.math.2014.11.011. Epub 2014 Dec 2.
Related trials for Shoulder Impingement
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 High Velocity, Low Amplitude Thrust Maneuver (HVLATM) and Scapular High Velocity, Low Amplitude Thrust Maneuver in people with Shoulder Impingement, run by UConn Health 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 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 26 Apr 2017. 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?
Shoulder Pain and Disability Index (SPADI) (time frame: 6-9 days following treatment). 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 NCT01743833, which also lists 2 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 26 Apr 2017.