Neck-specific Training or Prescribed Physical Activity for Patients With Cervical Radiculopathy
6 september 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
144
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Stockholm, Sverige, 17176
- Department of Physical Therapy, Karolinska University Hospital,
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Övrig: 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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Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Pain
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Disability
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Health related quality of life
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studiestol: Åsa Dedering, PhD, Karolinska Institutet
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2010
Primärt slutförande (Faktisk)
1 januari 2016
Avslutad studie (Faktisk)
1 mars 2017
Studieregistreringsdatum
Först inskickad
5 april 2013
Först inskickad som uppfyllde QC-kriterierna
10 april 2013
Första postat (Uppskatta)
15 april 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 september 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 september 2017
Senast verifierad
1 september 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KI: 2009/1756-31/4
Läkemedels- och apparatinformation, studiedokument
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