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Completed

NCT Number: NCT02083796

Short-term Effects of Thoracic Manipulation in Shoulder Impingement

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.

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Key information

Conditions

Shoulder Impingement Syndrome Joint Diseases Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shoulder impingement_TSM

Procedure

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

Asymptomatic_TSM

Procedure

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

Shoulder impingement_sham

Procedure

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

Asymptomatic_sham

Procedure

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

Primary outcomes

  1. Change in scapular orientation from first to third day

    Time frame: Day 1; day 2; day 3

    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.

Secondary outcomes

  1. Change in shoulder function from first to third day

    Time frame: Day 1; Day 2; Day 3

    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.

  2. Change in scapular muscle activity from first to third day

    Time frame: Day 1; Day 2; Day 3

    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.

  3. Change in shoulder pain from first to third day

    Time frame: Day 1; Day 2; Day 3

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 11, 2014
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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