Clinical trial NCT04104906: Motor Control Training in Individuals With Subacromial Pain Syndrome
Official title: Motor Control Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: Shoulder rehabilitation
Electromyography
Posture analysis
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The porpusose of this study is to evaluate the repercussions of a motor control exercise protocol in patients with subacromial pain syndrome without indication of surgical repair.

Detailed description: Methods: This is a randomized controlled trial which will be composed of volunteers of both genders, aged between 35 and 60 years. All volunteers will undergo pre-assessment (Av1): pain sensation, pain and function, shoulder range of motion, muscle strength, electromyographic activity and kinematics of the shoulder complex. After the initial evaluation, the volunteers will be randomly divided into two groups to carry out the intervention: exercises (GE - conventional exercises with elastic band) and motor control (GCM - motor control training). The intervention protocol will last eight weeks. After four weeks, the second assessment (AV2), similar to AV1, will be performed and the global change perception questionnaire will be added. At the end of the intervention protocol, the third evaluation (AV3), similar to AV2, will be performed. A follow-up will be performed after 4 weeks of the end of the intervention protocol, with the assessment being equal to AV3.

The project will be submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also be registered on the international clinical trial platform, ClinicalTrials.gov. The study will only begin after approval of the ethics and research committee. All volunteers should read and sign the terms of free and informed consent.

Eligibility criteria: Inclusion Criteria:

* Present subacromial pain with a score greater than or equal to 2 (Visual Analog Scale) for more than 2 months;
* Positive Neer test;
* Positive Hawkins test;
* Positive Jobe test (pain);
* Positive Patte test (pain);
* Involvement of the supraspinatus and / or infraspinatus tendon (without degenerative characteristics) confirmed by Magnetic Nuclear Resonance (MRI) examination.

Exclusion Criteria:

* Intense pain during the evaluations;
* Fail to properly perform the evaluation procedures;
* Two consecutive or five alternating absences during the training protocol.

Primary outcomes:
measure: Shoulder pain
timeFrame: Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
measure: Shoulder function
timeFrame: Change from baseline in shoulder function at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Secondary outcomes:
measure: Root Mean Square (RMS)
timeFrame: Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
measure: The kinematics of the scapula
timeFrame: Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
measure: Peak of muscular torque
timeFrame: Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
measure: Peak torque time
timeFrame: Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
measure: Range of motion
timeFrame: Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Jamilson S Brasileiro
state: RN
city: Parnamirim
country: Brazil
facility: Karinna Sonálya Aires da Costa
state: RN
Study officials:
References: