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

NCT01831271 | Completed DMC

• 1 other identifier: KI: 2009/1756-31/4
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Pain; Pain, Radiating

Keywords

Exercise, Physical; Physical Activity; Outcome Measures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disability

  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 (15)

• Health related quality of life

  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

  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

  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.

Study Arms (2)

Prescribed physical activity

OTHER

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

Neck specific training

OTHER

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

Interventions

Prescribed physical activity OTHER

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.

Prescribed physical activity

Neck specific training OTHER

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.

Neck specific training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Linkoeping University: collaborator

Study Sites (1)

Department of Physical Therapy, Karolinska University Hospital,

Stockholm, 17176, Sweden

Location

Related Publications (2)

• 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.

  PMID: 25115308 BACKGROUND

• 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.

  PMID: 30473018 DERIVED

MeSH Terms

Conditions

Neck Pain; Pain; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Åsa Dedering, PhD

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of Department

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 15, 2013
• Study Start: August 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 7, 2017

Record last verified: 2017-09

Locations

SE (1)