Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome
NCT ID: NCT03109704
Last Updated: 2019-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2016-02-01
2016-10-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exercise Application in the Treatment of Patients With Subacromial Pain Syndrome
NCT02695524
Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement
NCT01753271
Short-term Effects of Thoracic Manipulation in Shoulder Impingement
NCT02083796
Shoulder Eccentric External Rotator Training for Subacromial Pain Syndrome
NCT02153827
Effect of Thoracic Mobility Exercises Combined With Scapular Stabilization Exercises in Individuals With Subacromial Pain Syndrome
NCT07043842
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Supine thrust manipulation
The supine upper thoracic spine thrust manipulation will be performed two times, regardless of joint cavitation.
Supine upper thoracic spine thrust manipulation
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.
Seated thrust manipulation
The seated upper thoracic spine thrust manipulation will be performed two times, regardless of joint cavitation.
Seated upper thoracic spine thrust manipulation
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.
Sham manipulation
The sham manipulation will be performed two times.
Sham manipulation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Supine upper thoracic spine thrust manipulation
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.
Seated upper thoracic spine thrust manipulation
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.
Sham manipulation
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nova Southeastern University
OTHER
Sacred Heart University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jason Grimes, PT, PhD, OCS, ATC
Clinical Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jason K Grimes, PhD
Role: PRINCIPAL_INVESTIGATOR
Sacred Heart University
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
151119A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.