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

April 24, 2017 updated by: Augustus Mazzocca, UConn Health

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: 6-9 days following treatment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Numeric Pain Rating Scale
Time Frame: Pre, Post, and 6-9 days following treatment
Pre, Post, and 6-9 days following treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
5 point Likert scale to asses effects of messaging (positive vs. neutral)
Time Frame: Pre-intervention
Pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UConn Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Texas Tech University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #11-135-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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