Cervical Pain Clinical Trial
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
Verified date | September 2017 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | March 2017 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Physical Therapy, Karolinska University Hospital, | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Linkoeping University |
Sweden,
Dedering Å, 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health related quality of life | Health related quality of life is assessed by the EuroQuol 5 dimensions (EQ-5D). | 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 | Self-efficacy | Self-efficacy will be measured on the Self-efficacy and Exercise Self-efficacy scales | 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 | Symptom satisfaction | Symptom satisfaction is rated on 7-grade scale | 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 | Fear Avoidance Beliefs | Fear Avoidance Beliefs will be measured with Fear Avoidance Beliefs questionnaire (FABQ)and Tampa scale (TSK) | 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 | Depression | Hostility, anxiety and depression will be measured with Hostility, anxiety and depression scale (HAD) | 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 | Coping strategies | Coping strategies will be measured with Coping strategy questionnaire | 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 | Pain catastrophizing | Pain catastrophizing will be measured with Pain catastrophizing scale | 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 | Physical activity | Physical activity will be measured with International Physical activity questionnaire | 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 | Patients specific goals | Patients specific goals will measured with Patients specific functional scale and Patient goal assessment scale | 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 | Work ability | Work ability will be measured with Work Ability Index | 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 | Physical clinical outcome measures | Clinical examination | 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 | Cervical range of motion | 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 | Hand strength | 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 | Muscle fatigue | Electromyography on the neck muscles | Baseline and change after 15 weeks, 1 year follow up. The outcome measures is going to report a change over time. | |
Other | Neck muscle endurance | Neck muscle endurance time measured in sec for dorsal and ventral neck muscles during a static endurance test | Base line, 15 weeks, 6 months, 1 year, 2 years, The outcome measures is going to report a change over time. | |
Primary | Pain | Neck and Arm Pain is measured with Visual Analogue Scale | 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 | Disability | Neck Specific Disability is measured with Neck Disability Index (NDI) | 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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