- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04941586
Effectiveness of Pain Education Elderly Subacromial Pain (Subacromial)
27 juli 2022 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
74
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Rodrigo GS Carvalho, PhD
- Telefonnummer: +5587999832015
- E-post: rodrigocarvalhofisio@gmail.com
Studieorter
-
-
Pernambuco
-
Petrolina, Pernambuco, Brasilien, 56304917
- Rekrytering
- Physical Education College
-
Kontakt:
- Rodrigo GS Carvalho, PhD
- Telefonnummer: 8721016856
- E-post: rodrigo.carvalho@univasf.edu.br
-
Kontakt:
- Rodrigo GS Carvalho, PhD
- Telefonnummer: 8721016856
- E-post: rodrigocarvalhofisio@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år till 85 år (Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Shoulder Pain
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depression, Anxiety and Stress
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
29 maj 2021
Primärt slutförande (Förväntat)
1 juli 2023
Avslutad studie (Förväntat)
30 juli 2023
Studieregistreringsdatum
Först inskickad
29 maj 2021
Först inskickad som uppfyllde QC-kriterierna
25 juni 2021
Första postat (Faktisk)
28 juni 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juli 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juli 2022
Senast verifierad
1 juli 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MT-Subacromial
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Publish Study Protocol, Randomized Controlled Trial
Tidsram för IPD-delning
The data will become available as of 07/18/2022.
Kriterier för IPD Sharing Access
Sharing access by repository on line and journal.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .