Back to resultsThoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome
Primary Purpose
Subacromial Impingement, Subacromial Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Supine upper thoracic spine thrust manipulation
Seated upper thoracic spine thrust manipulation
Sham manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement focused on measuring scapular kinematics, thoracic spine, thrust manipulation
Eligibility Criteria
Inclusion Criteria:
- currently experiencing shoulder pain for less than 6 months
- at least 3 of the following findings: 1) pain localized to the proximal anterolateral shoulder region, 2) positive Neer or Hawkins-Kennedy impingement test, 3) pain with active shoulder elevation (which may include a painful arc), 4) active shoulder abduction ROM of at least 90°, 5) passive shoulder external rotation ROM of at least 45°, and 6) pain with isometric resisted abduction or external rotation
Exclusion Criteria:
- signs of a complete rotator cuff tear
- significant loss of glenohumeral motion
- acute inflammation
- cervical spine-related symptoms including a primary complaint of neck pain, signs of central nervous system or cervical nerve root involvement, or reproduction of shoulder or arm pain with cervical rotation, axial compression, or Spurling test
- previous neck or shoulder surgery
- positive apprehension test or relocation test
- history of shoulder fracture or dislocation
- history of nerve injury affecting upper extremity function
- any contraindication for thrust manipulation to the thoracic spine including osteoporosis, fracture, malignancy, systemic arthritis, or infection
- fear or unwillingness to undergo thoracic spine manipulation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Supine thrust manipulation
Seated thrust manipulation
Sham manipulation
Arm Description
The supine upper thoracic spine thrust manipulation will be performed two times, regardless of joint cavitation.
The seated upper thoracic spine thrust manipulation will be performed two times, regardless of joint cavitation.
The sham manipulation will be performed two times.
Outcomes
Primary Outcome Measures
Change in Penn Shoulder Score (PSS) from baseline to 48 hours
The Penn Shoulder Score is a 100-point shoulder-specific questionnaire with three subscales: self-reported pain, function, and satisfaction with current use of the shoulder. The scores from the subscales are summed to determine the total score with the pain subscale score ranging from 0-30, function subscale score ranging from 0-60, and satisfaction subscale score ranging from 0-10. The total maximum score of 100 points indicates high function, low pain, and high satisfaction with the shoulder.
Change in pain
Pain will be measured using the verbal numeric rating scale (VNRS). Participants will be asked to rate their pain on a 0-10 scale with 0 indicating no pain and 10 indicating the worst pain imaginable. This pain rating will be obtained during active elevation of the arm in the scapular plane.
Secondary Outcome Measures
Change in scapular upward rotation active range of motion (ROM)
The participant will start with the involved arm at the side of the body. The investigator will confirm the location of the scapular plane by placing the subject's arm at an angle 40 degrees anterior from the frontal plane as measured with a standard goniometer. The digital inclinometer will be zeroed on a horizontal surface and then placed along the scapular spine of the involved arm. The initial reading from the inclinometer on the scapular spine with the arm at the side of the body will be recorded. The subject will then be instructed to elevate the arm in the scapular plane as high as he/she can go. The final reading from the inclinometer will then be recorded at the end of the subject's maximal arm elevation. The total amount of scapular upward rotation will be calculated as the change score by taking the difference between the final and initial readings. Downward rotation would be recorded as negative values and upward rotation would be recorded as positive values.
Change in scapular posterior tilt active ROM
The participant will start with the test arm at the side of the body. The digital inclinometer will be zeroed on a vertical surface and then placed vertically along the posterior surface of the medial border of the scapula, using the root of the scapular spine and the inferior angle of the scapula as landmarks as previously described. The initial reading from the inclinometer with the arm at the side of the body will be recorded. The subject will then be instructed to elevate the arm in the scapular plane as high as he/she can go. The final reading from the inclinometer will then be recorded at the end of the subject's maximal arm elevation. The total amount of scapular posterior tilt will be calculated as the change score by taking the difference between the final and initial readings. Anterior tilt would be recorded as negative values and posterior tilt would be recorded as positive values.
Change in scapular upward rotation passive ROM
Measurements will be made with the subject in standing. The participant will start with the involved arm at the side of the body. The digital inclinometer will be zeroed and positioned as described for the measure of upward rotation active ROM. The initial reading from the inclinometer will be recorded. The examiner can then passively elevate the humerus in the scapular plane to end-range elevation, producing passive upward rotation of the scapula. The examiner will move the subject's arm through the full available elevation ROM passively for two consecutive trials. At the point of maximal passive arm elevation on the second repetition, the inclinometer will again be placed along the scapular spine to obtain a measurement of upward rotation passive ROM. The total amount of scapular upward rotation passive ROM will be calculated as the change score by taking the difference between the final and initial readings.
Change in scapular posterior tilt passive ROM
Measurements will be made with the subject standing. The digital inclinometer will be zeroed and positioned as described for the measure of posterior tilt active ROM. The initial reading from the inclinometer will be recorded with the subject's arm at the side of the body. The examiner can then passively elevate the humerus in the scapular plane to end-range elevation, producing passive posterior tilt of the scapula. The examiner will move the subject's arm through the full, available elevation ROM passively for two consecutive trials. At the point of maximal passive arm elevation on the second repetition, the inclinometer will again be placed along the posterior surface of the medial border of the scapula to obtain a measurement of posterior tilt passive ROM. The total amount of scapular posterior tilt passive ROM will be calculated as the change score by taking the difference between the final and initial readings.
Change in pectoralis minor muscle length
Performed as described previously by Borstad. A tape measure will be used to measure the linear distance in cm between the anterior-inferior edge of the 4th rib one finger width lateral to the sternum and the medial-inferior aspect of the coracoid process of the scapula. This measurement will be completed while the subject is standing in their usual resting position.
Change in middle trapezius force production
A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard manual muscle test (MMT) position using a "make test" as previously described. The "make test" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight.
Change in lower trapezius force production
A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard MMT position using a "make test" as previously described. The "make test" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight.
Change in serratus anterior force production
A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard MMT position using a "make test" as previously described. The "make test" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight.
Full Information
NCT ID
NCT03109704
First Posted
March 29, 2017
Last Updated
March 29, 2019
Sponsor
Sacred Heart University
Collaborators
Nova Southeastern University
1. Study Identification
Unique Protocol Identification Number
NCT03109704
Brief Title
Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome
Official Title
The Immediate Effects of a Seated Versus Supine Upper Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
October 24, 2016 (Actual)
Study Completion Date
October 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sacred Heart University
Collaborators
Nova Southeastern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the immediate and short-term effects of a supine upper thoracic spine thrust manipulation, seated upper thoracic spine thrust manipulation, and sham manipulation for individuals with subacromial pain syndrome. The participants were randomized to receive one of the three interventions and baseline measures for the dependent variables were repeated immediately after the delivery of the intervention.
Detailed Description
Thoracic spine thrust manipulation has been shown to be effective in reducing pain and improving function in individuals with subacromial pain syndrome (subacromial impingement). It remains unknown if individuals respond differently to different manipulation techniques. This study examines the immediate effects on pain and short-term effects on pain and function using the Penn Shoulder Score (PSS) as well as the immediate effects on scapular kinematics (upward rotation and posterior tilt, specifically), pectoralis minor muscle length, and scapulothoracic muscle force production for the middle trapezius, lower trapezius, and serratus anterior.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement, Subacromial Impingement Syndrome
Keywords
scapular kinematics, thoracic spine, thrust manipulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial, 3 groups which includes a sham comparator
Masking
Participant
Masking Description
participants were made aware of the 3 different interventions being investigated but were not told which technique they were assigned to receive
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supine thrust manipulation
Arm Type
Experimental
Arm Description
The supine upper thoracic spine thrust manipulation will be performed two times, regardless of joint cavitation.
Arm Title
Seated thrust manipulation
Arm Type
Experimental
Arm Description
The seated upper thoracic spine thrust manipulation will be performed two times, regardless of joint cavitation.
Arm Title
Sham manipulation
Arm Type
Sham Comparator
Arm Description
The sham manipulation will be performed two times.
Intervention Type
Procedure
Intervention Name(s)
Supine upper thoracic spine thrust manipulation
Intervention Description
The supine thrust manipulation will target the upper thoracic spine and will be performed as previously described. The patient will be asked to lace his or her fingers behind the neck and bring his or her elbows close together in front of the chest. The therapist will place one hand just below the targeted upper thoracic region (at either the T3 or T4 level) using a pistol grip or loose fist to make contact with both transverse processes of the T3 or T4 vertebrae. The therapist will then use his or her body to push down through the patient's upper arms to provide a high-velocity, low-amplitude thrust in the anterior-to-posterior direction.
Intervention Type
Procedure
Intervention Name(s)
Seated upper thoracic spine thrust manipulation
Other Intervention Name(s)
C-T junction distraction manipulation
Intervention Description
The seated thrust manipulation will target the cervicothoracic junction with the patient sitting with fingers laced behind the neck. The therapist will stand behind the patient and thread his or her arms through the patient's arms and clasp his or her hands near the C7-T1 level. The therapist will make contact with his or her chest against the patient's upper thoracic region to serve as a fulcrum. The patient will then be instructed to take a deep breath, and upon exhalation the therapist will apply a high-velocity, low-amplitude distraction thrust in a cephalad direction.
Intervention Type
Procedure
Intervention Name(s)
Sham manipulation
Intervention Description
The sham manipulation will be performed with the patient and the examiner positioned in the same manner as for the seated manipulation, however the examiner will apply only minimal pressure to maintain physical contact and "skin lock" with the patient. The examiner will then move the patient through the same range of motion but deliver no manipulative thrust.
Primary Outcome Measure Information:
Title
Change in Penn Shoulder Score (PSS) from baseline to 48 hours
Description
The Penn Shoulder Score is a 100-point shoulder-specific questionnaire with three subscales: self-reported pain, function, and satisfaction with current use of the shoulder. The scores from the subscales are summed to determine the total score with the pain subscale score ranging from 0-30, function subscale score ranging from 0-60, and satisfaction subscale score ranging from 0-10. The total maximum score of 100 points indicates high function, low pain, and high satisfaction with the shoulder.
Time Frame
baseline and 48 hours after intervention
Title
Change in pain
Description
Pain will be measured using the verbal numeric rating scale (VNRS). Participants will be asked to rate their pain on a 0-10 scale with 0 indicating no pain and 10 indicating the worst pain imaginable. This pain rating will be obtained during active elevation of the arm in the scapular plane.
Time Frame
baseline and 1 minute after intervention
Secondary Outcome Measure Information:
Title
Change in scapular upward rotation active range of motion (ROM)
Description
The participant will start with the involved arm at the side of the body. The investigator will confirm the location of the scapular plane by placing the subject's arm at an angle 40 degrees anterior from the frontal plane as measured with a standard goniometer. The digital inclinometer will be zeroed on a horizontal surface and then placed along the scapular spine of the involved arm. The initial reading from the inclinometer on the scapular spine with the arm at the side of the body will be recorded. The subject will then be instructed to elevate the arm in the scapular plane as high as he/she can go. The final reading from the inclinometer will then be recorded at the end of the subject's maximal arm elevation. The total amount of scapular upward rotation will be calculated as the change score by taking the difference between the final and initial readings. Downward rotation would be recorded as negative values and upward rotation would be recorded as positive values.
Time Frame
baseline and 1 minute after intervention
Title
Change in scapular posterior tilt active ROM
Description
The participant will start with the test arm at the side of the body. The digital inclinometer will be zeroed on a vertical surface and then placed vertically along the posterior surface of the medial border of the scapula, using the root of the scapular spine and the inferior angle of the scapula as landmarks as previously described. The initial reading from the inclinometer with the arm at the side of the body will be recorded. The subject will then be instructed to elevate the arm in the scapular plane as high as he/she can go. The final reading from the inclinometer will then be recorded at the end of the subject's maximal arm elevation. The total amount of scapular posterior tilt will be calculated as the change score by taking the difference between the final and initial readings. Anterior tilt would be recorded as negative values and posterior tilt would be recorded as positive values.
Time Frame
baseline and 1 minute after intervention
Title
Change in scapular upward rotation passive ROM
Description
Measurements will be made with the subject in standing. The participant will start with the involved arm at the side of the body. The digital inclinometer will be zeroed and positioned as described for the measure of upward rotation active ROM. The initial reading from the inclinometer will be recorded. The examiner can then passively elevate the humerus in the scapular plane to end-range elevation, producing passive upward rotation of the scapula. The examiner will move the subject's arm through the full available elevation ROM passively for two consecutive trials. At the point of maximal passive arm elevation on the second repetition, the inclinometer will again be placed along the scapular spine to obtain a measurement of upward rotation passive ROM. The total amount of scapular upward rotation passive ROM will be calculated as the change score by taking the difference between the final and initial readings.
Time Frame
baseline and 1 minute after intervention
Title
Change in scapular posterior tilt passive ROM
Description
Measurements will be made with the subject standing. The digital inclinometer will be zeroed and positioned as described for the measure of posterior tilt active ROM. The initial reading from the inclinometer will be recorded with the subject's arm at the side of the body. The examiner can then passively elevate the humerus in the scapular plane to end-range elevation, producing passive posterior tilt of the scapula. The examiner will move the subject's arm through the full, available elevation ROM passively for two consecutive trials. At the point of maximal passive arm elevation on the second repetition, the inclinometer will again be placed along the posterior surface of the medial border of the scapula to obtain a measurement of posterior tilt passive ROM. The total amount of scapular posterior tilt passive ROM will be calculated as the change score by taking the difference between the final and initial readings.
Time Frame
baseline and 1 minute after intervention
Title
Change in pectoralis minor muscle length
Description
Performed as described previously by Borstad. A tape measure will be used to measure the linear distance in cm between the anterior-inferior edge of the 4th rib one finger width lateral to the sternum and the medial-inferior aspect of the coracoid process of the scapula. This measurement will be completed while the subject is standing in their usual resting position.
Time Frame
baseline and 1 minute after intervention
Title
Change in middle trapezius force production
Description
A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard manual muscle test (MMT) position using a "make test" as previously described. The "make test" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight.
Time Frame
baseline and 1 minute after intervention
Title
Change in lower trapezius force production
Description
A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard MMT position using a "make test" as previously described. The "make test" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight.
Time Frame
baseline and 1 minute after intervention
Title
Change in serratus anterior force production
Description
A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard MMT position using a "make test" as previously described. The "make test" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight.
Time Frame
baseline and 1 minute after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
currently experiencing shoulder pain for less than 6 months
at least 3 of the following findings: 1) pain localized to the proximal anterolateral shoulder region, 2) positive Neer or Hawkins-Kennedy impingement test, 3) pain with active shoulder elevation (which may include a painful arc), 4) active shoulder abduction ROM of at least 90°, 5) passive shoulder external rotation ROM of at least 45°, and 6) pain with isometric resisted abduction or external rotation
Exclusion Criteria:
signs of a complete rotator cuff tear
significant loss of glenohumeral motion
acute inflammation
cervical spine-related symptoms including a primary complaint of neck pain, signs of central nervous system or cervical nerve root involvement, or reproduction of shoulder or arm pain with cervical rotation, axial compression, or Spurling test
previous neck or shoulder surgery
positive apprehension test or relocation test
history of shoulder fracture or dislocation
history of nerve injury affecting upper extremity function
any contraindication for thrust manipulation to the thoracic spine including osteoporosis, fracture, malignancy, systemic arthritis, or infection
fear or unwillingness to undergo thoracic spine manipulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason K Grimes, PhD
Organizational Affiliation
Sacred Heart University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
data regarding scapular kinematics during upper extremity elevation, pectoralis minor muscle length in standing, and force production in MMT positions for middle trapezius, lower trapezius, and serratus anterior; request for data should be made by email to: grimesj@sacredheart.edu
Citations:
PubMed Identifier
24853923
Citation
Haik MN, Alburquerque-Sendin F, Silva CZ, Siqueira-Junior AL, Ribeiro IL, Camargo PR. Scapular kinematics pre- and post-thoracic thrust manipulation in individuals with and without shoulder impingement symptoms: a randomized controlled study. J Orthop Sports Phys Ther. 2014 Jul;44(7):475-87. doi: 10.2519/jospt.2014.4760. Epub 2014 May 22.
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Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome
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