Clinical trial NCT01831271: Neck-specific Training or Prescribed Physical Activity for Patients With Cervical Radiculopathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Pain
Pain, Radiating
Keywords: Exercise, Physical
Physical Activity
Outcome Measures
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2013-04-15
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 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.
Secondary outcomes:
measure: Disability
timeFrame: 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.
Other outcomes:
measure: Health related quality of life
timeFrame: 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.
measure: Self-efficacy
timeFrame: 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.
measure: Symptom satisfaction
timeFrame: 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.
measure: Fear Avoidance Beliefs
timeFrame: 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.
measure: Depression
timeFrame: 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.
measure: Coping strategies
timeFrame: 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.
measure: Pain catastrophizing
timeFrame: 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.
measure: Physical activity
timeFrame: 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.
measure: Patients specific goals
timeFrame: 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.
measure: Work ability
timeFrame: 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.
measure: Physical clinical outcome measures
timeFrame: 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.
measure: Cervical range of motion
timeFrame: 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.
measure: Hand strength
timeFrame: 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.
measure: Muscle fatigue
timeFrame: Baseline and change after 15 weeks, 1 year follow up. The outcome measures is going to report a change over time.
measure: Neck muscle endurance
timeFrame: Base line, 15 weeks, 6 months, 1 year, 2 years, The outcome measures is going to report a change over time.
Locations:
city: Stockholm
country: Sweden
facility: Department of Physical Therapy, Karolinska University Hospital,
Study officials:
affiliation: Karolinska Institutet
name: Åsa Dedering, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.