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Motor Control Training in Individuals With Subacromial Pain Syndrome

29. april 2021 opdateret af: Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte

Motor Control Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

34

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • RN
      • Natal, RN, Brasilien, 59140-840
        • Jamilson S Brasileiro
      • Parnamirim, RN, Brasilien, 59152820
        • Karinna Sonálya Aires da Costa

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: motor control training
8-week exercise program, twice a week, with motor control training
Andet: motor control training
The volunteers of the motor control group will initiate the exercises on a stable and rigid basis. These will be progressed with adding an unstable base as the volunteer gains motor learning (between the fourth and fifth week of the protocol). For the motor control group, two sets of 10 repetitions will be performed keeping in isometry for ten seconds each repetition.
Aktiv komparator: exercises
8-week exercise program, twice a week.
Andet: The exercise group
the protocol of strengthening and will have five elastic bands with different resistances available (extra-light, light, moderate, strong and extra-strong) for elbow flexion exercises progression, medial rotation and lateral rotation of the shoulder and scapular retraction.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Shoulder pain
Tidsramme: Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Evaluation of pain level in the shoulder using the Numerical Pain Scale, graded from 0 to 10, where 0 indicates absence of pain and 10 indicates the worst pain imaginable.
Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Skulderfunktion
Tidsramme: Ændring fra baseline i skulderfunktion efter 4 uger, 8 uger og opfølgning efter 4 uger efter interventionsprotokollen
Evaluering af skuldersmerter og funktion ved hjælp af handicap i arm, skulder og hånd (DASH). Spørgeskemaet er et selvadministreret regionsspecifikt resultatinstrument udviklet som et mål for selvvurderet overekstremitetshandicap og symptomer. DASH består hovedsageligt af en 30-elements handicap/symptomskala, scoret fra 0 (ingen handicap) til 100. Jo højere score, jo større funktionsnedsættelse.
Ændring fra baseline i skulderfunktion efter 4 uger, 8 uger og opfølgning efter 4 uger efter interventionsprotokollen

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Root Mean Square (RMS)
Tidsramme: Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Analyze of the electromyographic activity of the muscles shoulder complex, after 4 and 8 weeks of the protocol and a follow up of 4 weeks after the intervention protocol, by Root Mean Square (RMS)
Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
The kinematics of the scapula
Tidsramme: Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Analyze the kinematics of the scapula and glenohumeral in the slow and habitual movements after 8 weeks of the protocol and a follow up of 4 weeks.
Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Peak of muscular torque
Tidsramme: Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Evaluate the peak of muscular torque, by means of the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Peak torque time
Tidsramme: Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Evaluate the peak torque time, using the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Range of motion
Tidsramme: Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
Measure the range of motion for flexion, hyperextension, internal and external shoulder rotation 8 weeks of protocol and a follow up of 4 weeks, through the inclinometer.
Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidade Federal do Rio Grande do Norte

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juni 2019

Primær færdiggørelse (Faktiske)

30. januar 2020

Studieafslutning (Faktiske)

30. januar 2020

Datoer for studieregistrering

Først indsendt

28. juni 2019

Først indsendt, der opfyldte QC-kriterier

24. september 2019

Først opslået (Faktiske)

26. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KSACO2019

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Kliniske forsøg med Skuldersmerter

Kliniske forsøg med motor control training

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