- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Östergötland
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Linköping, Östergötland, Sverige, SE 581 85
- Faculty of Health Sciences, Linköping University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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. |
|
Experimentell: 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.
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain
Tidsram: Before training, 4-6 months and after one year of training.
|
Methods of measurement: Surveys, physical tests, microdialysis.
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Before training, 4-6 months and after one year of training.
|
|
Function
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Muscle biochemistry
Tidsram: Before training, 4-6 months follow-up and 12 months follow-up
|
Biochemical substances from the interstitium of the trapezius muscle will be determined eg, serotonin, glutmate, lactate, pyruvate, endocannabinoids.
|
Before training, 4-6 months follow-up and 12 months follow-up
|
|
Psychological factors
Tidsram: Before training, 4-6 months follow-up and 12 months follow-up
|
Aspects concerning psychological distress will be followed eg depression and anxiety using Hospital Anxiety and Depression Scale (HADS).
|
Before training, 4-6 months follow-up and 12 months follow-up
|
|
Pain sensitivity
Tidsram: Before training, 4-6 months follow-up and 12 months follow-up
|
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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Britt Larsson, Assoc Prof, rehabilitation medicine, Faculty of Health Sciences, Linköping University, SE 581 85, Linköping, Sweden
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LIU-001
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