Influence of Interferential Current Therapy in the Treatment of Individuals With Shoulder Impact Syndrome: A Randomized, Placebo Controlled Clinical Trial.

NCT02964819 | Completed DMC

• 1 other identifier: 51675615.3.0000.5511
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pain

  10 months

• Catastrophizing of the Pain

  10 months

Study Arms (3)

exercise group

ACTIVE COMPARATOR

Manual cervical traction, Myofascial release of upper trapezius muscle, 3 sets of 1 minute;Sleeper's stretch, during 3 series of 30 seconds,Punch exercise, Knee push-up plus, Prone V-raise exercise (arms abducted at 120°), rotador cuff exercise (internal rotation), rotador cuff exercise (external rotation), Rotation on the wall using a ball (internal rotation), Rotation on the wall using a ball (external rotation).

Other: exercise

exercise + Interferential current group

EXPERIMENTAL

Addition to the exercise protocol performed in the exercise group the interferential current. Four self-adhesive electrodes (8x5 cm), two upper and two lower ones (forming a square) will be placed around the center of the shoulder. The electrodes will be positioned crosswise, following the parameters: 4KHz (carrier frequency), 1/1 second (swing pattern), 100 Hz Frequency modulation amplitude (AMF), 50 Hz (sweep frequency), automatic vector mode, With intensity at the motor threshold of sensation, with duration of 50 minutes.

Other: exercise; Device: Interferential current therapy

exercise + US group

PLACEBO COMPARATOR

In addition to the exercise protocol performed in the exercise group, an ultrasound device will be used. The appliance will be used off, without any individual participant having knowledge. For this, the individual will be asked to position himself in the dorsal position on the stretcher, the therapist will perform the application of the transducer head, with gel on its surface, in the anterolateral region of the affected shoulder.

Other: exercise; Device: Therapeutic Ultrasound

Interventions

exercise OTHER

exercise + Interferential current group; exercise + US group; exercise group

Interferential current therapy DEVICE

exercise + Interferential current group

Therapeutic Ultrasound DEVICE

exercise + US group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Exercise; Electric Stimulation Therapy; Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Rehabilitation; Diathermy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 16, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

BR (1)