Neck-specific Training or Prescribed Physical Activity for Patients With Cervical Radiculopathy

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.

Study Overview

• Status: Completed
• Conditions: Cervical Pain; Pain, Radiating
• Intervention / Treatment: Other: Prescribed physical activity; Other: Neck specific training

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Department of Physical Therapy, Karolinska University Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.
Other: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Linkoeping University
• Investigators: Study Chair: Åsa Dedering, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise, Physical; Outcome Measures
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neck Pain; Radiculopathy; Pain
• Other Study ID Numbers: KI: 2009/1756-31/4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No