- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05226845
Is Patient Choice of Exercise Preference Important in Chronic Neck Pain?
8. februar 2022 opdateret af: Alexander Achalandabaso, University of Jaén
Is Patient Choice of Exercise Preference Important in Chronic Neck Pain? A Randomized Clinical Study
Nonspecific chronic neck pain is the third most frequent problem in Spain.
It has an annual presence between 15% and 50% where women are the most affected.
This pain influences the psychosocial state of the person.
Physical exercise has been shown to be effective in a wide variety of chronic pain conditions, including improving quality of life and emotional problems.
Design: Single-blind, controlled, randomized clinical trial.
Methods: The study will be approached in the Faculty of Nursing and Physiotherapy of the University of Alcalá.
52 subjects with nonspecific chronic neck pain will be selected and randomly divided into two groups.
The first group should perform 5 exercises that have been shown to be effective in the management of neck pain selected by the physiotherapist focused on neck pain.
The second group must choose, from a list of exercises that have been shown to be effective in the management of neck pain, 5 exercises.
Both groups should record the pain, the number of repetitions and the series performed.
The duration of the intervention will be a total of 8 weeks with evaluations pre-intervention, post-intervention and 4 weeks after the end of the intervention.
The objective of this study is to evaluate if the exercise chosen by the patient is better than the exercises selected by the physiotherapist for the variables chronic neck pain, strength of the affected muscles, kinesiophobia and adherence to treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Madrid, Spanien, 28805
- Universidad de Alcala
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Madrid
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Alcalá De Henares, Madrid, Spanien, 28805
- Alexander achalandabaso
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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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- chronic neck pain
Exclusion Criteria:
- Spine surgery, shoulder girdle or cervical area surgery, whether traumatic or not.
- Rheumatic pathology.
- Impaired cognitive function.
- Vascular pathology that prevents exercise.
- Cardiopulmonary pathology that prevents exercise.
- Fear of any of the tests or measurements to be carried out.
- Pregnant
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 |
|---|---|
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Eksperimentel: exercise to improve the neck strength in neck pain chosen by the therapist
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the therapist chooses the five exercises to do
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Eksperimentel: exercise to improve the neck strength in neck pain chosen by the patient
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the patient chooses the five exercises to perform among fifteen possibilities
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in Disability
Tidsramme: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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using the Neck Disability Index Questionnaire.
It is a scale whose values range from 0 to 50.
The higher the score, the greater the disability.
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Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in kinesiophobia
Tidsramme: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
|
using Tampa scale of kinesiophobia (TSK-11).
It is a scale whose values range from11 to 44.
The higher the score, the greater the kinesiophobia.
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Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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Changes in muscular endurance
Tidsramme: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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using Grimmer test
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Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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Adherence to treatment
Tidsramme: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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using a journal entry
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Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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changes in pain
Tidsramme: Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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Using the visual analog scale.
It is a 100-mm long horizontal line.
Zero means no pain, 100-mm means the worst pain imaginable.
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Baseline, 8 weeks (primary timepoint) and 4 weeks after intervention.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.
- Ambrose KR, Golightly YM. Physical exercise as non-pharmacological treatment of chronic pain: Why and when. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):120-30. doi: 10.1016/j.berh.2015.04.022. Epub 2015 May 23.
- Polaski AM, Phelps AL, Kostek MC, Szucs KA, Kolber BJ. Exercise-induced hypoalgesia: A meta-analysis of exercise dosing for the treatment of chronic pain. PLoS One. 2019 Jan 9;14(1):e0210418. doi: 10.1371/journal.pone.0210418. eCollection 2019.
- Sluka KA, Frey-Law L, Hoeger Bement M. Exercise-induced pain and analgesia? Underlying mechanisms and clinical translation. Pain. 2018 Sep;159 Suppl 1(Suppl 1):S91-S97. doi: 10.1097/j.pain.0000000000001235.
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)
1. juli 2021
Primær færdiggørelse (Faktiske)
30. juli 2021
Studieafslutning (Faktiske)
30. oktober 2021
Datoer for studieregistrering
Først indsendt
4. december 2021
Først indsendt, der opfyldte QC-kriterier
25. januar 2022
Først opslået (Faktiske)
7. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Alcalá University
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