- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04104906
Motor Control Training in Individuals With Subacromial Pain Syndrome
Motor Control Training in Individuals With Subacromial Pain Syndrome: Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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RN
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Natal, RN, Brasil, 59140-840
- Jamilson S Brasileiro
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Parnamirim, RN, Brasil, 59152820
- Karinna Sonálya Aires da Costa
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: motor control training
8-week exercise program, twice a week, with motor control training
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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.
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Aktiv komparator: exercises
8-week exercise program, twice a week.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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.
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Change from baseline in shoulder pain at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Skulderfunksjon
Tidsramme: Endring fra baseline i skulderfunksjon ved 4 uker, 8 uker og oppfølging av 4 uker etter intervensjonsprotokollen
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Evaluering av skuldersmerter og funksjon ved bruk av funksjonshemminger i arm, skulder og hånd (DASH).
Spørreskjemaet er et selvadministrert regionspesifikt utfallsinstrument utviklet som et mål på selvvurdert funksjonshemming og symptomer i øvre ekstremiteter.
DASH består hovedsakelig av en 30-elements funksjonshemming/symptomskala, scoret fra 0 (ingen funksjonshemming) til 100.
Jo høyere skår, jo større funksjonshemming.
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Endring fra baseline i skulderfunksjon ved 4 uker, 8 uker og oppfølging av 4 uker etter intervensjonsprotokollen
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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)
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Change from baseline in RMS at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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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
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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.
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Change from baseline in kinematics of the scapular girdle at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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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
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Evaluate the peak of muscular torque, by means of the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
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Change from baseline in peak of muscular torque at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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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
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Evaluate the peak torque time, using the manual dynamometer 8 weeks of the protocol and a follow up of 4 weeks.
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Change from baseline in peak torque time at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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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
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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.
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Change from baseline in range of motion at 4 weeks, 8 weeks and follow up of 4 weeks after the intervention protocol
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KSACO2019
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Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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