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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02964819
Other study ID # 51675615.3.0000.5511
Secondary ID
Status Completed
Phase N/A
First received November 13, 2016
Last updated January 15, 2017
Start date January 2016
Est. completion date December 2016

Study information

Verified date January 2017
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project will analyze the influence of interferential current therapy in an exercise program for individuals with a unilateral impact syndrome diagnosis. To that end, volunteers of both genders, aged 18-59 years, had an unilateral, unilateral pain in the shoulder with more than 3 months duration, at least grade 4 pain by the numerical scale of pain assessment, positivity In at least 2 of 3 orthopedic tests for impact syndrome, will be randomized into the following groups: exercise group, exercise + ultrasound group, exercise group + interferential current. Sixteen consecutive treatment sessions will be performed, and the volunteers will be evaluated before and after, by means of the following instruments: Numerical scale of evaluation of pain, Shoulder pain and disability index (SPADI), Pain-Related Catastrophizing Thoughts Scale, being applied the Numerical scale of evaluation of pain at the end of Each session and one month after the end of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria:

- History of anterolateral, unilateral pain in the shoulder with more than 3 months duration.

- Medical diagnosis,

- minimal grade 4 pain by numerical scale of pain assessment,

- positivity in at least 2 of 3 orthopedic tests for impact syndrome: Neer, Hawkins or Jobe.

Exclusion Criteria:

- Fibromyalgia diagnosis,

- pregnancy,

- numbness or tingling in the upper limb

- History of shoulder trauma, other shoulder related diseases,

- ruptured tendons, ligament laxity,

- symptoms of numbness and / or Tingling in the upper limbs, history of shoulder and / or cervical surgery

- use of corticosteroid injection in the shoulder, and analgesic, anti-inflammatory or muscle relaxant use and have or have undergone physiotherapeutic treatment in the last 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
exercise

Device:
Interferential current therapy

Therapeutic Ultrasound


Locations

Country Name City State
Brazil University of Nove de Julho Sao Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary physical function and pain The Shoulder pain and disability index in the numerical version consists of 13 items distributed in the domain of pain (five items) and function (eight items), each item being scored on a numerical rating scale of 0 to 10 points. The final score of the questionnaire, as well as the score obtained separately by each domain, is converted into a percentage for values ranging from 0 to 100, with the highest score indicating worse shoulder dysfunction condition. 10 months
Secondary pain Numeric pain rating scale 10 months
Secondary Catastrophizing of the Pain Pain-Related Catastrophizing Thoughts Scale 10 months
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