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CompletedNCT01743833Updated Apr 26, 2017

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

An interventional study of Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM) and Scapular High Velocity, Low Amplitude Thrust Maneuver in Shoulder Impingement, sponsored by UConn Health. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2017-04-26.

Sponsored by UConn Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Shoulder Impingement
03

In context

Shoulder Impingement Syndrome

312 studies on the registry are indexed under Shoulder Impingement Syndrome; 58 are open to participants now.

This study's enrollment of 97 is above the median of 54 across 267 interventional studies indexed under Shoulder Impingement Syndrome.

Browse Shoulder Impingement Syndrome studies →

Lead sponsor

UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
97 participants (actual)

Study arms

  • 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

Interventions

  • OtherThoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)
  • OtherScapular High Velocity, Low Amplitude Thrust Maneuver
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What researchers measure

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.

    Time frame: 6-9 days following treatment

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: Pre, Post, and 6-9 days following treatment

Other outcomes

  1. 5 point Likert scale to asses effects of messaging (positive vs. neutral)

    Time frame: Pre-intervention

07

Study locations

1 site
  • University of Connecicut Health Center
    Farmington, Connecticut 06030-4038, United States
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References and documents

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 25560477 ↗
  • 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. PubMed 25543999 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01743833
Lead sponsor
UConn Health
Collaborators
Texas Tech University
Responsible party
Augustus Mazzocca (Director, New England Musculoskeletal Institute Chairman, Department of Orthopaedic Surgery, UConn Health) — Principal investigator
First posted
Dec 6, 2012
Start date
Jun 2011
Primary completion
Dec 5, 2012
Completion
Dec 5, 2012
Last update
Apr 26, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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