- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02424032
Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain
18. april 2015 opdateret af: Seyda TOPRAK CELENAY
The aim of this study was to investigate and compared the effects of cervical and scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for patients with chronic mechanical neck pain.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Sixty patients with chronic mechanical neck pain were recruited and randomly allocated into stabilization exercise with and without the connective tissue massage program.
The study's inclusion criteria were as follows: 18 to 65 years of age, having neck pain for more than 3 months, and being volunteer.
The exclusion criteria were as follows: stenosis, traumatic injury history, previous surgery related to cervical spine, hypermobility, cancer, having inflammatory rheumatologic, severe psychological disorders, being pregnant, and intervention including exercise or physical therapy in the last 3 months.The program was carried out for 12 sessions, 3 days/week in 4 weeks.
Pain intensity with Visual Analog Scale, pressure pain threshold with digital algometer, the level of anxiety with the Spielberger State Trait Anxiety Inventory, and life quality with Short Form-36 were evaluated before and after treatment.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
53
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Cankaya
-
Ankara, Cankaya, Kalkun, 06800
- Rekruttering
- Ataturk Trainning and Research Hospital
-
Kontakt:
- Seyda - TOPRAK CELENAY, Assist. Prof
- Telefonnummer: +90 0534 041 39 86
- E-mail: sydtoprak@hotmail.com
-
Ankara, Cankaya, Kalkun
- Rekruttering
- Ataturk Trainning and Research Hospital
-
Kontakt:
- Seyda TOPRAK CELENAY
- Telefonnummer: 490-534-041-3986
- E-mail: sydtoprak@hotmail.com
-
-
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:
- 18 to 65 years of age,
- having neck pain for more than 3 months, and
- being volunteer
Exclusion Criteria:
- Stenosis,
- traumatic injury history,
- previous surgery related to cervical spine,
- hypermobility,
- cancer,
- having inflammatory rheumatologic,
- severe psychological disorders,
- being pregnant, and
- intervention including exercise or physical therapy in the last 3 months
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: Faktoriel opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Exercise and connective tissue massage
Stabilization exercise and connective tissue massage have been applied
|
Cervical and scapulothoracic stabilization exercises with connective tissue massage were performed.The program was carried out for 12 sessions, 3 days/week in 4 weeks.
|
Aktiv komparator: Exercise
Only stabilization exercise has been applied
|
Cervical and scapulothoracic stabilization exercises were performed.
The program was carried out for 12 sessions, 3 days/week in 4 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Neck pain intensity as measured by Visual Analog Scale
Tidsramme: Change from baseline neck pain intensity at 4 weeks
|
Change from baseline neck pain intensity at 4 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory
Tidsramme: Change from baseline level of anxiety at 4 weeks
|
Change from baseline level of anxiety at 4 weeks
|
Change in quality of life as assessed by Short Form-36
Tidsramme: Change from baseline quality of life at 4 weeks
|
Change from baseline quality of life at 4 weeks
|
Change in pressure pain threshold as measured by digital algometer
Tidsramme: Change from baseline pressure pain threshold at 4 weeks
|
Change from baseline pressure pain threshold at 4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Seyda TOPRAK CELENAY, Ataturk Trainning and Research Hospital
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
- Bakar Y, Sertel M, Ozturk A, Yumin ET, Tatarli N, Ankarali H. Short term effects of classic massage compared to connective tissue massage on pressure pain threshold and muscle relaxation response in women with chronic neck pain: a preliminary study. J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):415-21. doi: 10.1016/j.jmpt.2014.05.004. Epub 2014 Aug 6.
- Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.
- Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
- Sherman KJ, Cherkin DC, Hawkes RJ, Miglioretti DL, Deyo RA. Randomized trial of therapeutic massage for chronic neck pain. Clin J Pain. 2009 Mar-Apr;25(3):233-8. doi: 10.1097/AJP.0b013e31818b7912.
- Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.
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
1. februar 2013
Primær færdiggørelse (Forventet)
1. maj 2015
Datoer for studieregistrering
Først indsendt
8. april 2015
Først indsendt, der opfyldte QC-kriterier
18. april 2015
Først opslået (Skøn)
22. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
22. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GO 13/381
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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