Back to resultsEffects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement
Primary Purpose
Shoulder Impingement
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)
Scapular High Velocity, Low Amplitude Thrust Maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement
Eligibility Criteria
Inclusion Criteria:
- 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°
Exclusion Criteria:
- 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.
Sites / Locations
- University of Connecicut Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Thoracic HVLAMT, Postive Message
Thoracic HVLATM, Neutral Message
Scapular HVLATM, Positive Message
Scapular HVLATM, Neutral Message
Arm Description
Thoracic HVLAMT with a positive message given prior to the intervention.
Thoracic HVLAMT with a neutral message given prior to the intervention.
Scapular HVLAMT with a positive message given prior to the intervention.
Scapular HVLAMT with a neutral message given prior to the intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Numeric Pain Rating Scale
Full Information
NCT ID
NCT01743833
First Posted
November 30, 2012
Last Updated
April 24, 2017
Sponsor
UConn Health
Collaborators
Texas Tech University
1. Study Identification
Unique Protocol Identification Number
NCT01743833
Brief Title
Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement
Official Title
Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 5, 2012 (Actual)
Study Completion Date
December 5, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Texas Tech University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thoracic HVLAMT, Postive Message
Arm Type
Active Comparator
Arm Description
Thoracic HVLAMT with a positive message given prior to the intervention.
Arm Title
Thoracic HVLATM, Neutral Message
Arm Type
Active Comparator
Arm Description
Thoracic HVLAMT with a neutral message given prior to the intervention.
Arm Title
Scapular HVLATM, Positive Message
Arm Type
Active Comparator
Arm Description
Scapular HVLAMT with a positive message given prior to the intervention.
Arm Title
Scapular HVLATM, Neutral Message
Arm Type
Active Comparator
Arm Description
Scapular HVLAMT with a neutral message given prior to the intervention.
Intervention Type
Other
Intervention Name(s)
Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)
Intervention Type
Other
Intervention Name(s)
Scapular High Velocity, Low Amplitude Thrust Maneuver
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
The primary outcome measure is SPADI score at 6-9 days post intervention. The SPADI is also collected pretreatment and immediately post treatment.
Time Frame
6-9 days following treatment
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Time Frame
Pre, Post, and 6-9 days following treatment
Other Pre-specified Outcome Measures:
Title
5 point Likert scale to asses effects of messaging (positive vs. neutral)
Time Frame
Pre-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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°
Exclusion Criteria:
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.
Facility Information:
Facility Name
University of Connecicut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-4038
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25560477
Citation
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.
Results Reference
derived
PubMed Identifier
25543999
Citation
Riley 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.
Results Reference
derived
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Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement
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