- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01876680
The Effects of Two Different Home-exercise Programmes on Women Suffering Long Term Neck/Shoulder Muscle Pain
The Effects (Pain, Function, Biochemistry and Psychological Factors) of Two Different Home-exercise Programmes on Women Suffering Long Term Nack/Shoulder Muscle Pain
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Östergötland
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Linköping, Östergötland, Suède, SE 581 85
- Faculty of Health Sciences, Linköping University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- female
- 20-60
- long term neck/shoulder muscle pain
- willing to exercise
Exclusion Criteria:
- widespread pain
- pregnancy
- major trauma in medical history
- tendonitis in upper extremities
- neurological causes of the pain
- inflammatory and hormonal disorders
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group 1: Stretching and aerobic exercise
Group 1 undertook a stretching programme for neck/shoulder muscles three times weekly and performed aerobic exercise för 30 minutes three times weekly.
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Stretching programme for neck/shoulder muscles three times weekly and aerobic exercise för 30 minutes three times weekly. Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year. |
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Expérimental: Group 2: Strength training
Group 2 undertook a stretching programme for neck/shoulder muscles three times weekly, performed aerobic exercise three times weekly and performed weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly.
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Stretching programme for neck/shoulder muscles three times weekly, aerobic exercise för 30 minutes three times weekly and weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly. Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain
Délai: Before training, 4-6 months and after one year of training.
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Methods of measurement: Surveys, physical tests, microdialysis.
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Before training, 4-6 months and after one year of training.
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Function
Délai: Before training, 4-6 months and after one year of training.
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Methods of measurement: Surveys, physical tests, microdialysis.
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Before training, 4-6 months and after one year of training.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Muscle biochemistry
Délai: Before training, 4-6 months follow-up and 12 months follow-up
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Biochemical substances from the interstitium of the trapezius muscle will be determined eg, serotonin, glutmate, lactate, pyruvate, endocannabinoids.
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Before training, 4-6 months follow-up and 12 months follow-up
|
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Psychological factors
Délai: Before training, 4-6 months follow-up and 12 months follow-up
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Aspects concerning psychological distress will be followed eg depression and anxiety using Hospital Anxiety and Depression Scale (HADS).
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Before training, 4-6 months follow-up and 12 months follow-up
|
|
Pain sensitivity
Délai: Before training, 4-6 months follow-up and 12 months follow-up
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Pain thresholds for pressure (algometry) and heat and cold (QST) will be registered.
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Before training, 4-6 months follow-up and 12 months follow-up
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Britt Larsson, Assoc Prof, rehabilitation medicine, Faculty of Health Sciences, Linköping University, SE 581 85, Linköping, Sweden
Publications et liens utiles
Publications générales
- Ghafouri N, Ghafouri B, Fowler CJ, Larsson B, Turkina MV, Karlsson L, Gerdle B. Effects of two different specific neck exercise interventions on palmitoylethanolamide and stearoylethanolamide concentrations in the interstitium of the trapezius muscle in women with chronic neck shoulder pain. Pain Med. 2014 Aug;15(8):1379-89. doi: 10.1111/pme.12486. Epub 2014 Jul 4.
- Karlsson L, Takala EP, Gerdle B, Larsson B. Evaluation of pain and function after two home exercise programs in a clinical trial on women with chronic neck pain - with special emphasises on completers and responders. BMC Musculoskelet Disord. 2014 Jan 8;15:6. doi: 10.1186/1471-2474-15-6.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LIU-001
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