- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01831271
Neck-specific Training or Prescribed Physical Activity for Patients With Cervical Radiculopathy
6. september 2017 opdateret af: Åsa Dedering, Karolinska University Hospital
Interventions for Patients With Cervical Radiculopathy- Neck-specific Training With a Cognitive Behavioural Approach Compared With Prescribed Physical Activity in a Prospective Randomised Controlled Trial
The overall objective is to evaluate if treatment with a neck-specific exercise program and cognitive behavioural approach improves the outcome compared with prescribed, self-mediated and progressive physical activity in patients with cervical radiculopathy.
There is a lack of evidence of the best treatment for the patient category.
Many patients are sick-listed for long periods of time with different kind of treatment approaches or without any treatment at all.
The present study could fill the identified knowledge gap by strengthening of the currently weak scientific evidence for treatment of the patient category.
The long-term effects of the study could be to reduce the time for sick leave and improve the rate of patients returning to work and/ or former activity by optimising treatments.
Further on, to decrease the number of patients who finally have surgery for their neck problems and thus reducing the mental, physical and social costs.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients with cervical radiculopathy have neck- and arm pain, neurological changes, activity limitations and difficulties in returning to work.
The current scientific evidence lacks randomised controlled trials to compare surgery with conservative treatment as well as to evaluate different conservative interventions.
Most patients are not candidates for surgery and are sick-listed for long time with different treatment approaches or without any treatment at all.
The purpose is to evaluate if treatment with neck-specific training and a cognitive behavioral approach improves the outcome compared with prescribed physical activity.
Methods: A randomized controlled trial including 144 patients will compare the intervention neck specific training and cognitive behavioural approach with an intervention of prescribed physical activity.
The interventions will be led by experienced and specialised physiotherapists and last 14 weeks.
Main outcome variable is pain intensity (VAS scale) accompanied with assessments of impairments and subjective health measurements undertaken before intervention and at 3, 6, 12 and 24 months.
Implementation: The results will be presented scientifically as well as popularly in publications and professional meetings.
Active implementation strategies to change physiotherapists treatment behaviour will be used.
The best method will be chosen after surveying the physiotherapists treating patients in the current study regarding experiences, education and organisational context.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
144
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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Stockholm, Sverige, 17176
- Department of Physical Therapy, Karolinska University Hospital,
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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 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Magnetic Resonance Imaging (MRI) verified cervical disc disease showing cervical nerve root compression
- Positive Spurling sign and/or cervical extension test
- Clinical examination signs matching the MRI
Exclusion Criteria:
- earlier fracture or luxation of the cervical column,
- malignity,
- spinal tumour,
- spinal infection,
- previous surgery in the cervical column,
- co-morbidity such as disease or symptoms contraindicated to perform the treatment program or the measurements,
- known drug abuse,
- lack of familiarity with the Swedish language,
- diagnosed psychiatric disorder
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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Andet: Prescribed physical activity
Prescribed physical activity is a tailored physical activity programme with monitoring of progress and a follow-up.
Also includes interview: exploratory talk, commitment/decision, life style change, health promotion, evaluation of readiness for change, reflection, assessment of motivation, patient specific goal assessment, conclusion and plan for follow-up at 14 weeks.
Patients are guided by the physiotherapist to increase their overall activity and strength with i.e. walking and other self-mediated activities and exercise.
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Prescribed physical activity is a tailored physical activity programme with monitoring of progress and a follow-up.
Also includes interview: exploratory talk, commitment/decision, life style change, health promotion, evaluation of readiness for change, reflection, assessment of motivation, patient specific goal assessment, conclusion and plan for follow-up at 14 weeks.
Patients are guided by the physiotherapist to increase their overall activity and strength with i.e. walking and other self-mediated activities and exercise.
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Andet: Neck specific training
The active physiotherapy rehabilitation program consists of a standardised and structured physiotherapy program (twice a week) with medical exercise therapy and if needed vestibular rehabilitation.
At the start of the intervention motivational interviewing will be included.
Additionally once a week during the first 14 weeks of the program the physiotherapist informs the patient about physiology of pain, stress, exercise, breathing, relaxation, coping, pacing and ergonomics.
All through the treatment program a cognitive approach from the physiotherapist according to theoretical behaviour change models will be used.
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The active physiotherapy rehabilitation program consists of a standardised and structured physiotherapy program (twice a week) with medical exercise therapy and if needed vestibular rehabilitation.
At the start of the intervention motivational interviewing will be included.
Additionally once a week during the first 14 weeks of the program the physiotherapist informs the patient about physiology of pain, stress, exercise, breathing, relaxation, coping, pacing and ergonomics.
All through the treatment program a cognitive approach from the physiotherapist according to theoretical behaviour change models will be used.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pain
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Neck and Arm Pain is measured with Visual Analogue Scale
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Disability
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Neck Specific Disability is measured with Neck Disability Index (NDI)
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Health related quality of life
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Health related quality of life is assessed by the EuroQuol 5 dimensions (EQ-5D).
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Self-efficacy
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Self-efficacy will be measured on the Self-efficacy and Exercise Self-efficacy scales
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Symptom satisfaction
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Symptom satisfaction is rated on 7-grade scale
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Fear Avoidance Beliefs
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Fear Avoidance Beliefs will be measured with Fear Avoidance Beliefs questionnaire (FABQ)and Tampa scale (TSK)
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Depression
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Hostility, anxiety and depression will be measured with Hostility, anxiety and depression scale (HAD)
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Coping strategies
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Coping strategies will be measured with Coping strategy questionnaire
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Pain catastrophizing
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Pain catastrophizing will be measured with Pain catastrophizing scale
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Physical activity
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Physical activity will be measured with International Physical activity questionnaire
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Patients specific goals
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Patients specific goals will measured with Patients specific functional scale and Patient goal assessment scale
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Work ability
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Work ability will be measured with Work Ability Index
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Physical clinical outcome measures
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Clinical examination
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Cervical range of motion
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Hand strength
Tidsramme: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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Muscle fatigue
Tidsramme: Baseline and change after 15 weeks, 1 year follow up. The outcome measures is going to report a change over time.
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Electromyography on the neck muscles
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Baseline and change after 15 weeks, 1 year follow up. The outcome measures is going to report a change over time.
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Neck muscle endurance
Tidsramme: Base line, 15 weeks, 6 months, 1 year, 2 years, The outcome measures is going to report a change over time.
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Neck muscle endurance time measured in sec for dorsal and ventral neck muscles during a static endurance test
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Base line, 15 weeks, 6 months, 1 year, 2 years, The outcome measures is going to report a change over time.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Åsa Dedering, PhD, Karolinska Institutet
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
- Dedering A, Halvorsen M, Cleland J, Svensson M, Peolsson A. Neck-specific training with a cognitive behavioural approach compared with prescribed physical activity in patients with cervical radiculopathy: a protocol of a prospective randomised clinical trial. BMC Musculoskelet Disord. 2014 Aug 12;15:274. doi: 10.1186/1471-2474-15-274.
- Dedering A, Peolsson A, Cleland JA, Halvorsen M, Svensson MA, Kierkegaard M. The Effects of Neck-Specific Training Versus Prescribed Physical Activity on Pain and Disability in Patients With Cervical Radiculopathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2447-2456. doi: 10.1016/j.apmr.2018.06.008. Epub 2018 Jul 4.
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. august 2010
Primær færdiggørelse (Faktiske)
1. januar 2016
Studieafslutning (Faktiske)
1. marts 2017
Datoer for studieregistrering
Først indsendt
5. april 2013
Først indsendt, der opfyldte QC-kriterier
10. april 2013
Først opslået (Skøn)
15. april 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KI: 2009/1756-31/4
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