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

NCT01743833 | Completed

• 1 other identifier: #11-135-3
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement

Outcome Measures

Primary Outcomes (1)

• 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.

  6-9 days following treatment

Secondary Outcomes (1)

• Numeric Pain Rating Scale

  Pre, Post, and 6-9 days following treatment

Other Outcomes (1)

• 5 point Likert scale to asses effects of messaging (positive vs. neutral)

  Pre-intervention

Study Arms (4)

Thoracic HVLAMT, Postive Message

ACTIVE COMPARATOR

Thoracic HVLAMT with a positive message given prior to the intervention.

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.

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.

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.

Other: Scapular High Velocity, Low Amplitude Thrust Maneuver

Interventions

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

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: lead
• Texas Tech University: collaborator

Study Sites (1)

University of Connecicut Health Center

Farmington, Connecticut, 06030-4038, United States

Location

Related Publications (2)

• 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.

  PMID: 25560477 DERIVED

• 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.

  PMID: 25543999 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, New England Musculoskeletal Institute Chairman, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 6, 2012
• Study Start: June 1, 2011
• Primary Completion: December 5, 2012
• Study Completion: December 5, 2012
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

US (1)