Short-term Effects of Thoracic Manipulation in Shoulder Impingement

NCT ID: NCT02083796

Last Updated: 2015-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

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.

Conditions

Shoulder Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Shoulder impingement_TSM

Intervention Type: PROCEDURE

A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.

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.

Group Type: SHAM_COMPARATOR

Shoulder impingement_sham

Intervention Type: PROCEDURE

A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.

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

Group Type: ACTIVE_COMPARATOR

Asymptomatic_TSM

Intervention Type: PROCEDURE

A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.

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.

Group Type: SHAM_COMPARATOR

Asymptomatic_sham

Intervention Type: PROCEDURE

A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.

Interventions

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.

Intervention Type: PROCEDURE

Asymptomatic_TSM

A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Spine manipulation; Spinal manipulation; (Spinal) Thrust; Spine manipulation; Spinal manipulation; (Spinal) Thrust; Sham spinal manipulation; Sham spinal manipulation

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Melina Nevoeiro Haik

Master

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula R Camargo, doctor

Role: STUDY_DIRECTOR

Universidade Federal de Sao Carlos

Locations

Universidade Federal de São Carlos

São Carlos, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 28259517 (View on PubMed)

Other Identifiers

Ethics Committee 465/2011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Haik-0607

Identifier Type: -

Identifier Source: org_study_id