Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Connecticut Health Center
Sponsor:
Collaborator:
Texas Tech University
Information provided by (Responsible Party):
Augustus Mazzocca, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01743833
First received: November 30, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Shoulder Impingement
Other: Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)
Other: Scapular High Velocity, Low Amplitude Thrust Maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Thoracic Orthopedic Manual Therapy and Biopsychosocial Variables on Signs of Shoulder Impingement: A Randomized Clinical Trial

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Shoulder Pain and Disability Index (SPADI) [ Time Frame: 6-9 days following treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre, Post, and 6-9 days following treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 5 point Likert scale to asses effects of messaging (positive vs. neutral) [ Time Frame: Pre-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thoracic HVLAMT, Postive Message
Thoracic HVLAMT with a positive message given prior to the intervention.
Other: Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)
Active Comparator: Thoracic HVLATM, Neutral Message
Thoracic HVLAMT with a neutral message given prior to the intervention.
Other: Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)
Active Comparator: Scapular HVLATM, Positive Message
Scapular HVLAMT with a positive message given prior to the intervention.
Other: Scapular High Velocity, Low Amplitude Thrust Maneuver
Active Comparator: Scapular HVLATM, Neutral Message
Scapular HVLAMT with a neutral message given prior to the intervention.
Other: Scapular High Velocity, Low Amplitude Thrust Maneuver

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743833

Locations
United States, Connecticut
University of Connecicut Health Center Recruiting
Farmington, Connecticut, United States, 06030-4038
Contact: Sean Riley    860-679-3233      
Sponsors and Collaborators
University of Connecticut Health Center
Texas Tech University
  More Information

No publications provided

Responsible Party: Augustus Mazzocca, nterim Director, New England Musculoskeletal Institute Interim Chairman, Department of Orthopaedic Surgery, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01743833     History of Changes
Other Study ID Numbers: #11-135-3
Study First Received: November 30, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014