Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome

NCT03109704 | Completed

• 1 other identifier: 151119A
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Subacromial Impingement; Subacromial Impingement Syndrome

Keywords

scapular kinematics; thoracic spine; thrust manipulation

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline and 48 hours after intervention

• 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.

  baseline and 1 minute after intervention

Secondary Outcomes (8)

• Change in scapular upward rotation active range of motion (ROM)

  baseline and 1 minute after intervention

• Change in scapular posterior tilt active ROM

  baseline and 1 minute after intervention

• Change in scapular upward rotation passive ROM

  baseline and 1 minute after intervention

• Change in scapular posterior tilt passive ROM

  baseline and 1 minute after intervention

• Change in pectoralis minor muscle length

  baseline and 1 minute after intervention

Study Arms (3)

Supine thrust manipulation

EXPERIMENTAL

The supine upper thoracic spine thrust manipulation will be performed two times, regardless of joint cavitation.

Procedure: Supine upper thoracic spine thrust manipulation

Seated thrust manipulation

EXPERIMENTAL

The seated upper thoracic spine thrust manipulation will be performed two times, regardless of joint cavitation.

Procedure: Seated upper thoracic spine thrust manipulation

Sham manipulation

SHAM COMPARATOR

The sham manipulation will be performed two times.

Procedure: Sham manipulation

Interventions

Supine upper thoracic spine thrust manipulation PROCEDURE

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.

Supine thrust manipulation

Seated upper thoracic spine thrust manipulation PROCEDURE

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.

Also known as: C-T junction distraction manipulation

Seated thrust manipulation

Sham manipulation PROCEDURE

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.

Sham manipulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sacred Heart University: lead
• Nova Southeastern University: collaborator

Related Publications (13)

• 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.

  PMID: 24853923 BACKGROUND

• Muth S, Barbe MF, Lauer R, McClure PW. The effects of thoracic spine manipulation in subjects with signs of rotator cuff tendinopathy. J Orthop Sports Phys Ther. 2012 Dec;42(12):1005-16. doi: 10.2519/jospt.2012.4142. Epub 2012 Aug 17.

  PMID: 22951537 BACKGROUND

• Kardouni JR, Pidcoe PE, Shaffer SW, Finucane SD, Cheatham SA, Sousa CO, Michener LA. Thoracic Spine Manipulation in Individuals With Subacromial Impingement Syndrome Does Not Immediately Alter Thoracic Spine Kinematics, Thoracic Excursion, or Scapular Kinematics: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Jul;45(7):527-38. doi: 10.2519/jospt.2015.5647. Epub 2015 May 21.

  PMID: 25996365 BACKGROUND

• Boyles RE, Ritland BM, Miracle BM, Barclay DM, Faul MS, Moore JH, Koppenhaver SL, Wainner RS. The short-term effects of thoracic spine thrust manipulation on patients with shoulder impingement syndrome. Man Ther. 2009 Aug;14(4):375-80. doi: 10.1016/j.math.2008.05.005. Epub 2008 Aug 15.

  PMID: 18703377 BACKGROUND

• Strunce JB, Walker MJ, Boyles RE, Young BA. The immediate effects of thoracic spine and rib manipulation on subjects with primary complaints of shoulder pain. J Man Manip Ther. 2009;17(4):230-6. doi: 10.1179/106698109791352102.

  PMID: 20140154 BACKGROUND

• Mintken PE, Cleland JA, Carpenter KJ, Bieniek ML, Keirns M, Whitman JM. Some factors predict successful short-term outcomes in individuals with shoulder pain receiving cervicothoracic manipulation: a single-arm trial. Phys Ther. 2010 Jan;90(1):26-42. doi: 10.2522/ptj.20090095. Epub 2009 Dec 3.

  PMID: 19959652 BACKGROUND

• 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.

  PMID: 16596890 BACKGROUND

• Johnson MP, McClure PW, Karduna AR. New method to assess scapular upward rotation in subjects with shoulder pathology. J Orthop Sports Phys Ther. 2001 Feb;31(2):81-9. doi: 10.2519/jospt.2001.31.2.81.

  PMID: 11232742 BACKGROUND

• Scibek JS, Carcia CR. Validation of a new method for assessing scapular anterior-posterior tilt. Int J Sports Phys Ther. 2014 Oct;9(5):644-56.

  PMID: 25328827 BACKGROUND

• Watson L, Balster SM, Finch C, Dalziel R. Measurement of scapula upward rotation: a reliable clinical procedure. Br J Sports Med. 2005 Sep;39(9):599-603. doi: 10.1136/bjsm.2004.013243.

  PMID: 16118295 BACKGROUND

• Borstad JD. Measurement of pectoralis minor muscle length: validation and clinical application. J Orthop Sports Phys Ther. 2008 Apr;38(4):169-74. doi: 10.2519/jospt.2008.2723. Epub 2007 Nov 21.

  PMID: 18434665 BACKGROUND

• Michener LA, Boardman ND, Pidcoe PE, Frith AM. Scapular muscle tests in subjects with shoulder pain and functional loss: reliability and construct validity. Phys Ther. 2005 Nov;85(11):1128-38.

  PMID: 16253043 BACKGROUND

• 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.

  PMID: 25261090 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Jason K Grimes, PhD

  Sacred Heart University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants were made aware of the 3 different interventions being investigated but were not told which technique they were assigned to receive
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: randomized controlled trial, 3 groups which includes a sham comparator

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 12, 2017
• Study Start: February 1, 2016
• Primary Completion: October 24, 2016
• Study Completion: October 26, 2016
• Last Updated: April 3, 2019

Record last verified: 2019-03