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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02463526
Other study ID # U1111-1154-7379
Secondary ID 28898014.3.0000.
Status Completed
Phase N/A
First received April 30, 2015
Last updated December 20, 2015
Start date April 2015
Est. completion date December 2015

Study information

Verified date December 2015
Source Universidade Federal de Sao Carlos
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Participants will be initially assessed for their suitability for inclusion in the study and will undergo a physical screening of the affected shoulder and cervical spine by an experienced physiotherapist. After, participants will be attended 72 hours after data recording of the baseline measures (range of motion with a goniometer, pressure pain threshold with a algometer, and peak force with a dynamometer) for four sessions per week with 24 hours of interval between sessions. At each experimental week session, each participant will receive one of the two treatment conditions (MWM or sham) and then will repeats the assessment. In the following week, there will be a crossover condition of each individual and 24 hours after the last treatment session, the examiner will do the last assessment.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- history of shoulder pain of >1-week duration, localized at the proximal anterolateral shoulder region consistent to Shoulder Impingement Syndrome (SIS);

- at least 1 positive impingement test (Jobe's test, Neer's test, Hawkins-Kennedy's Test) associated with painful range of motion during arm elevation; or pain during external rotation with the arm in 90 degrees of elevation in the coronal plane.

Exclusion Criteria:

- fibromyalgia (based on self-report),pregnancy, a history of onset of symptoms because of traumatic injury, other histories of shoulder injury, torn tendons, ligamentous laxity based on positive Sulcus test and apprehension test, numbness or tingling in the upper extremity, previous shoulder or neck surgery, systemic illnesses, body mass index > 28kg/m2, corticosteroid injection 3 months before evaluation, physical therapy 3 months before evaluation.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Mobilization with Movement (MWM) condition/ Sham condition
The treatment condition consists in the application of a posterolateral glide (MWM) in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the humerus head anterior aspect. A posterior glide will be applied to the humeral head. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. Sham condition will replicate treatment condition except for the hand positioning. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed.
Sham condition/ Mobilization with Movement (MWM) condition
The Sham condition consists in the application of a simulated anterior glide in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. The treatment condition will replicate treatment condition except for the hand positioning. The therapist will place one hand over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior humerus head. A posterior glide will be applied to the humeral head.

Locations

Country Name City State
Brazil UFSCar São Carlos São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal de Sao Carlos Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure Pain Threshold The pressure pain threshold will be assessed with a algometer and the unit of measure is the kilogram per square centimeter. 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment. Yes
Secondary Range of Motion The range of motion will be assessed with a goniometer and the unit of measure is the degree 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment. Yes
Secondary Peak Force The Peak Force will be assessed with a handheld dynamometer and the unit of measure is the kilogram. 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment. Yes
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