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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement
• Intervention / Treatment: Other: Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM); 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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030-4038
      • University of Connecicut Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Numeric Pain Rating Scale	Pre, Post, and 6-9 days following treatment

Other Outcome Measures

Outcome Measure	Time Frame
5 point Likert scale to asses effects of messaging (positive vs. neutral)	Pre-intervention

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Texas Tech University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 5, 2012
• Study Completion (Actual): December 5, 2012

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: #11-135-3