- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04941586
Effectiveness of Pain Education Elderly Subacromial Pain (Subacromial)
27. juli 2022 oppdatert av: Rodrigo Gustavo da Silva Carvalho
Effectiveness of Pain Education in the Treatment of the Elderly With Subacromial Pain: Randomized Controlled Trial
Objective: To verify the effectiveness of education in pain added to other treatment modalities (manual therapy and exercises) in the outcomes of pain, functionality, depression, anxiety, stress, kinesiophobia, self-efficacy and strength.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Introduction: Shoulder pain is one of the most common causes of musculoskeletal complaints found in primary care, with subacromial impact syndrome being the most common.
Aging is one of the risk factors for shoulder pain.
While psychological factors, which include negative beliefs about pain, catastrophization, kinesiophobia and low self-efficacy, all are related to high levels of pain and disability in the shoulder, predisposing to failure in conservative treatment.
Objectives: To verify the effectiveness of pain education added to other treatment modalities (manual therapy and exercises) in the outcomes of pain, functionality, depression, anxiety, stress, kinesiophobia, self-efficacy and strength.
Methodology: Randomized controlled clinical trial, which will last for one month of intervention and follow-up for three months.
Primary Outcomes: Shoulder Pain and Disability Index Questionnaire that evaluates (pain and disability), Pressure Algometer (pain to pressure) and Visual Analogue Scale (pain).
Secondary outcomes: Questionnaire (DASS-21), which evaluates depression, anxiety and stress, Tampa Scale (kinesiophobia), Chronic Pain Self-Efficacy Scale (Self-efficacy) and manual dynamometer that evaluates strength.
74 patients with a diagnosis of subacromial pain, of both sexes, aged between 65 and 85 years will be treated, who will be allocated into two groups: (37 patients for each group).
Group A: Manual Therapy + Exercises, individual assistance, twice a week lasting 40 min.
(20 min.
For each therapy); Group B: Manual Therapy + Exercises + Pain Education, individual care, twice a week lasting 60 min.
(20 min.
For each therapy.
Statistical analysis: The normality distribution will be through the Shapiro-Wilk test.
For comparisons of means between and within the groups of outcomes, they will be used using the Generalized Estimation Equations and when necessary , multiple comparisons will be performed using the Bonferroni test, calculated for comparisons between the final and initial moments and initial follow-up in each group: difference in means, 95% confidence interval, effect size (d Cohen).
statistical significance adopted will be 5% and the analyzes will be carried out in the statistical programs SPSS 22.0 and R 3.2.4.
Studietype
Intervensjonell
Registrering (Forventet)
74
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Rodrigo GS Carvalho, PhD
- Telefonnummer: +5587999832015
- E-post: rodrigocarvalhofisio@gmail.com
Studiesteder
-
-
Pernambuco
-
Petrolina, Pernambuco, Brasil, 56304917
- Rekruttering
- Physical Education College
-
Ta kontakt med:
- Rodrigo GS Carvalho, PhD
- Telefonnummer: 8721016856
- E-post: rodrigo.carvalho@univasf.edu.br
-
Ta kontakt med:
- Rodrigo GS Carvalho, PhD
- Telefonnummer: 8721016856
- E-post: rodrigocarvalhofisio@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år til 85 år (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age between 65 and 85 years old;
- Singns and symptoms of subacromial pain for at least 24 weeks;
- Medical diagnosis and ultrasound examination;
- Who do not have diseases such as: cervical radiculopathies, fractures, massive tendon ruptures, glenohumeral instabilities, dislocations and descompensated diabetes, and who have undergone surgery, infiltration or physiotherapy in the last 3 months.
Exclusion Criteria:
- Patients who do not undergo treatment in one of the groups for two consecutive sessions will be excluded from the study;
- In case the participants have any discomfort or any adverse reaction, the treatment will be suspended, after the evaluation of the evaluating researchers.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Education in pain, Manual Therapy and Exercises
The therapies will be performed by one a physical therapist with experience in rehabilitation, twice a week, lasting 60 minutes, for one month.
Each therapy will last 20 minutes.
|
twice a week, lasting 60 minutes, for one month
Andre navn:
|
|
Aktiv komparator: Manual Therapy and Exercises
The terapies will be performed by one a physical therapist with experience in rehabilitation, twice a week, lasting 40 minutes, for one month.
Each therapy will last 20 minutes.
|
twice a week, lasting 40 minutes, for one month
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder Pain
Tidsramme: change pain at four weeks and follow-up at four weeks
|
Shoulder Pain and Disability Index (SPADI) (better 0- 100 worse points)
|
change pain at four weeks and follow-up at four weeks
|
|
Functionality
Tidsramme: change functionality at four weeks and follow-up at four weeks
|
Shoulder Pain and Disability Index (SPADI) (better 0-100 worse points)
|
change functionality at four weeks and follow-up at four weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depression, Anxiety and Stress
Tidsramme: change depression, anxiety and stress at four weeks and follow-up at four weeks
|
Depression, Anxiety and Stress Scale (DASS-21) (better 0 - 63 worse point)
|
change depression, anxiety and stress at four weeks and follow-up at four weeks
|
|
Kinesiophobia
Tidsramme: change kinesiophobia at four weeks and follow-up at four weeks
|
Tampa Scale (better 0 - 68 worse points)
|
change kinesiophobia at four weeks and follow-up at four weeks
|
|
Self-Efficacy
Tidsramme: change self-efficacy at four weeks and follow-up at four weeks
|
Chronic Pain Self-Efficacy Scale (worse 200 - 2.000 better points)
|
change self-efficacy at four weeks and follow-up at four weeks
|
|
Muscle Strength
Tidsramme: change muscle Strength at four weeks and follow-up at four weeks
|
Hand-Held (less force worse - more strength better)
|
change muscle Strength at four weeks and follow-up at four weeks
|
|
Pressure Pain
Tidsramme: change at four weeks and follow-up at four weeks
|
Pressure Algometer (an average of three applications will be the pressure-supported pain threshold)
|
change at four weeks and follow-up at four weeks
|
|
Subjective Pain
Tidsramme: change at four weeks and follow-up at four weeks
|
Analogic Visual Scale (EVA) (better 0-10 worse points)
|
change at four weeks and follow-up at four weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. mai 2021
Primær fullføring (Forventet)
1. juli 2023
Studiet fullført (Forventet)
30. juli 2023
Datoer for studieregistrering
Først innsendt
29. mai 2021
Først innsendt som oppfylte QC-kriteriene
25. juni 2021
Først lagt ut (Faktiske)
28. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juli 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MT-Subacromial
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Publish Study Protocol, Randomized Controlled Trial
IPD-delingstidsramme
The data will become available as of 07/18/2022.
Tilgangskriterier for IPD-deling
Sharing access by repository on line and journal.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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