Clinical trial NCT03109704: 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
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement
Subacromial Impingement Syndrome
Keywords: scapular kinematics
thoracic spine
thrust manipulation
Lead sponsor: Sacred Heart University
Sponsor class: OTHER
Collaborators: name: Nova Southeastern University
First posted: 2017-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial, 3 groups which includes a sham comparator
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Penn Shoulder Score (PSS) from baseline to 48 hours
timeFrame: baseline and 48 hours after intervention
measure: Change in pain
timeFrame: baseline and 1 minute after intervention
Secondary outcomes:
measure: Change in scapular upward rotation active range of motion (ROM)
timeFrame: baseline and 1 minute after intervention
measure: Change in scapular posterior tilt active ROM
timeFrame: baseline and 1 minute after intervention
measure: Change in scapular upward rotation passive ROM
timeFrame: baseline and 1 minute after intervention
measure: Change in scapular posterior tilt passive ROM
timeFrame: baseline and 1 minute after intervention
measure: Change in pectoralis minor muscle length
timeFrame: baseline and 1 minute after intervention
measure: Change in middle trapezius force production
timeFrame: baseline and 1 minute after intervention
measure: Change in lower trapezius force production
timeFrame: baseline and 1 minute after intervention
measure: Change in serratus anterior force production
timeFrame: baseline and 1 minute after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Sacred Heart University
name: Jason K Grimes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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citation: Leggin BG, Michener LA, Shaffer MA, Brenneman SK, Iannotti JP, Williams GR Jr. The Penn shoulder score: reliability and validity. J Orthop Sports Phys Ther. 2006 Mar;36(3):138-51. doi: 10.2519/jospt.2006.36.3.138.
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citation: Michener LA, Kardouni JR, Sousa CO, Ely JM. Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain. Man Ther. 2015 Feb;20(1):171-5. doi: 10.1016/j.math.2014.08.008. Epub 2014 Sep 6.