Short-term Effects of Thoracic Manipulation in Shoulder Impingement

Short-term Effects of Thoracic Manipulation on Scapular Kinematics, Muscle Activity and Pain in Shoulder Impingement. A Randomized Controlled Trial

The hypothesis of this study is that thoracic spine manipulation would reduce pain in subjects with SIS and cause changes in scapular kinematics and muscle activity in subjects with impingement symptoms and in asymptomatic subjects. With this study, the investigators want to answer if possible changes in scapular motion and muscle activity following a TSM depend on the symptoms or if it is generic to individuals without shoulder dysfunction and not specific to subjects with shoulder impingement.

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Procedure: Shoulder impingement_TSM; Procedure: Shoulder impingement_sham; Procedure: Asymptomatic_TSM; Procedure: Asymptomatic_sham

Detailed Description

Subjects with shoulder impingement signs will be evaluated and will be compared with subjects asymptomatic for shoulder symptoms. Both subjects will be randomly assigned to one of two intervention groups: thoracic spinal manipulation (TSM) or sham intervention. We want to know if possible changes in scapular motion and muscle activity following a TSM depend on the symptoms or if it is generic to everyone. Also, we want to know if TSM reduces shoulder pain immediately and in a short-therm period.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil, 13565-905
      • Universidade Federal de Sao Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria (symptomatic subjects): To present with at least 3 of the following findings:

• positive Neer impingement test,
• positive Hawkins impingement test,
• positive Jobe test,
• pain with passive or isometric resisted shoulder lateral rotation,
• pain with active shoulder elevation,
• pain with palpation of rotator cuff tendons,
• pain in the C5 or C6 dermatome region.

Exclusion Criteria (symptomatic subjects):

• signs of "red flags" for spinal manipulation (eg, fracture, osteoporosis, malignancy, infection, and active inflammatory process),
• pregnancy
• systemic illnesses
• if received physical therapy or manual therapy treatment within the 6 months prior to the evaluation
• signs of complete rotator cuff tear or acute inflammation
• cervical-thoracic spine related symptoms (ie, positive cervical compression test and excessive kyphosis)
• scoliosis
• glenohumeral instability (ie, positive apprehension, anterior drawer, or sulcus tests)
• previous upper extremity fracture or shoulder surgery.

Exclusion Criteria (asymptomatic subjects):

• any positive test for shoulder impingement
• signs of "red flags" for spinal manipulation (eg, fracture, osteoporosis, malignancy, infection, and active inflammatory process),
• pregnancy
• systemic illnesses
• if received physical therapy or manual therapy treatment within the 6 months prior to the evaluation
• signs of complete rotator cuff tear or acute inflammation
• cervical-thoracic spine related symptoms (ie, positive cervical compression test and excessive kyphosis)
• scoliosis
• glenohumeral instability (ie, positive apprehension, anterior drawer, or sulcus tests)
• previous upper extremity fracture or shoulder surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shoulder impingement_TSM; For the manipulation intervention, the subjects were in a seated position and a thrust technique was performed. If no cavitation was detected with the manipulation, the thrust was repeated up to 3 times.	Procedure: Shoulder impingement_TSM; A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.; Other Names: Spine manipulation; Spinal manipulation; (Spinal) Thrust
Sham Comparator: Shoulder impingement_sham; For the sham intervention, the subjects were positioned in the same seated position with the therapist holding the patient in the same position as for the thrust manipulation. In this position, the therapist applied all the same forces as done for a thrust-manipulation and held that position for a few seconds, but a thrust was not used.	Procedure: Shoulder impingement_sham; A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.; Other Names: Sham spinal manipulation
Active Comparator: Asymptomatic_TSM; For the manipulation intervention, the subjects were in a seated position and a thrust technique was performed. If no cavitation was detected with the manipulation, the thrust was repeated up to 3 times	Procedure: Asymptomatic_TSM; A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.; Other Names: Spine manipulation; Spinal manipulation; (Spinal) Thrust
Sham Comparator: Asymptomatic_sham; For the sham intervention, the subjects were positioned in the same seated position with the therapist holding the patient in the same position as for the thrust manipulation. In this position, the therapist applied all the same forces as done for a thrust-manipulation and held that position for a few seconds, but a thrust was not used.	Procedure: Asymptomatic_sham; A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.; Other Names: Sham spinal manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scapular orientation from first to third day	3D scapular kinematic (upward/downward rotation; internal/external rotation; anterior/posterior tilt) was assessed pre- and-post thoracic spinal manipulation and sham interventions at first and second days. At the third day of evaluation the measure was assessed only once.	Day 1; day 2; day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in shoulder function from first to third day	Shoulder function was assessed at the beginning of each data collection day (days 1 to 3) using Disabilities of the Arm, Shoulder and Hand (DASH) and Western Ontario Rotator Cuff Index (WORC) questionnaires.	Day 1; Day 2; Day 3
Change in scapular muscle activity from first to third day	3D scapular kinematic was assessed pre- and-post thoracic spinal manipulation and sham interventions at first and second days. At the third day of evaluation the measure was assessed only once.	Day 1; Day 2; Day 3
Change in shoulder pain from first to third day	Shoulder pain was assessed pre- and-post thoracic spinal manipulation and sham interventions at first and second days. At the third day of evaluation the measure was assessed only once.	Day 1; Day 2; Day 3

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Director: Paula R Camargo, doctor, Universidade Federal de Sao Carlos

Publications and helpful links

General Publications

• Haik MN, Alburquerque-Sendin F, Camargo PR. Short-Term Effects of Thoracic Spine Manipulation on Shoulder Impingement Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1594-1605. doi: 10.1016/j.apmr.2017.02.003. Epub 2017 Mar 1.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2015
• Last Update Submitted That Met QC Criteria: October 26, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: rehabilitation; manual therapy; spine; shoulder
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: Haik-0607; Ethics Committee 465/2011 (Other Grant/Funding Number: FAPESP / 2013/07120-1)