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Physiotherapy After Anterior Cervical Spine Surgery

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ClinicalTrials.gov Identifier: NCT03036007
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Anneli Peolsson, Linkoeping University

Brief Summary:

Background: Patients suffering residual disability after anterior decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSE). Currently, we lack data for the success of either approach. There is also a knowledge-gap concerning the use of internet-based care for chronic neck pain, inclusive of cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrants increased efforts to investigate and improve cost-effective rehabilitation.

Objective: To investigate the effectiveness of a structured, internet-based NSE program, versus PPA following ACDF surgery.

Methods: This is a prospective, randomised, experimental, longitudinal multicentre study, that includes 140 patients with residual disability (≥30% on the Neck Disability Index; NDI) following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs following attendance at routine clinical appointments, scheduled for 3-months post-surgery. Patients are then randomised to one of two groups (70 patients/group), scheduled for a 3-month treatment of either internet-based NSE or PPA. Questionnaires on background data, pain and discomfort, physical and mental capacity, satisfaction with care, and health and workplace factors are completed, with physical measurements of neck-related function performed by independent test leaders blinded to randomisation. Measurements are performed at inclusion, after the 3-month treatments (end of treatment), and at a 2-year follow-up. Radiography will be completed at the 2-year follow-up. Preoperative data will be collected from the Swedish Spine Registry (Swespine). Data on healthcare consumption, drug use, and sick leave will be requested from the relevant national registers.


Condition or disease Intervention/treatment Phase
Cervical Disc Disease Radiculopathy, Cervical Other: Prescribed Physical Activity Other: Exercises with Internet support Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiotherapy After Anterior Cervical Spine Surgery for Cervical Disc Disease. A Prospective Randomised Study to Compare Internet-based Neck-specific Exercise With Prescribed Physical Activity
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: Prescribed Physical Activity
General physical exercises combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.
Other: Prescribed Physical Activity
General physical activity prescribed by a physiotherapist

Experimental: Exercises with Internet support
Neck-specific exercises with Internet support combined with 3 visits at a physiotherapy clinic (plus an additional first visit), exercises mainly performed outside the health care system during 12 weeks.
Other: Exercises with Internet support
Neck-specific exercise with Internet support




Primary Outcome Measures :
  1. Neck Disability Index (NDI) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Preoperative data from the Swespine register ]
    Self-reported neck-specific function


Secondary Outcome Measures :
  1. Pain intensities of the neck, arm, and head, measured using the Visual Analogue Scale (VAS 0-100 mm). [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Pre-operative data from the Swespine register ]
    Pain intensity VAS

  2. Pain intensities for the neck and arm will be assessed and registered using the Numeric Rating Scale (NRS) 0-10 scale in accordance with the Swespine registry [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Pain intensity NRS

  3. Distribution of pain by a Pain Drawing assessed with images [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    painful areas are shaded on a human body image

  4. Use of pain medications [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Use of pain medications

  5. Modified Odom [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    global outcomes of the intervention

  6. Dizziness/balance by the Dizziness Handicap Inventory (DHI) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Self-reported dizziness

  7. Headache questions by VAS and the Headache Handicap Inventory (HIT-6) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Impact of headache

  8. Disaster thoughts measured by the Pain Catastrophising Scale (PCS). [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Disaster thoughts

  9. Confidence in ability measured by the Self-Efficacy Scale (SES). [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Confidence in ability

  10. Patient Specific Functional Scale (PSFS). [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Estimation of neck-specific function related to participants' chosen activities (daily function, work, spare time

  11. Fear Avoidance Beliefs Questionnaire (FABQ). [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Operating fear

  12. Hospital Anxiety and Depression Scale (HAD). [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Self-reported anxiety and depression

  13. Health related quality of life measured by the EuroQuol five dimensions (EQ-5D) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Health related quality of life

  14. Work Ability Index (WAI), short form [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Self-rated work ability

  15. Requirements - effort support in the workplace: Effort Reward Imbalance (ERI) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    effort and support in the workplace

  16. Ergonomics questions and how work is perceived [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Work ergonomics

  17. Sickness presence measured by the Stanford preseenteism scale [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Sickness presence at work

  18. Swedish Standard Classification of Occupations (SSY) code [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Classification of Occupations

  19. Patient Enablement Instrument (PEI) questionnaire [ Time Frame: Follow-up at 3 months (the end of treatment) and 24 months follow-up ]
    Patient Enablement

  20. Satisfaction with symptoms measured by the Cherkin symptom satisfaction scale [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Satisfaction with symptoms

  21. Level of physical activity score, a combination of 2 questions (everyday physical activity and exercise/sport/open-air activity) to a combined 4-point score [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Physical activity

  22. Health-care consumption, number of visits [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Health-care consumption

  23. Consumption of analgesic drugs prescribed through the drug registry [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Consumption of analgesic drugs

  24. Frequency of pain [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Frequency of pain

  25. Sick-leave registration, number of days and episodes [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Sick-leave registration

  26. Neck movement measured using the cervical range of motion device (CROM) in degrees [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Active range of motion

  27. Endurance in the dorsal and ventral neck muscles, measured in seconds [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Neck muscle endurance

  28. Sensorimotor control of ventral neck muscles, in the supine position, with stabilizer (mm HG) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Sensorimotor control

  29. Neurology, clinical judgement yes/no [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Neurology, such as reflexes, sensibility, muscle weakness and neural tension test. The results of the neurological examination gives an overall clinical judgement if segmental neurological findings is present and which cervical segmental level/ - is involved,

  30. Hand strength measured with a hand dynamometer (Jamar) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Hand strength

  31. Standing on one leg with eyes closed (Solec test) [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Static balance

  32. Conventional radiography, with side views taken during neutral positioning and dynamic flexion/extension [ Time Frame: Occurs routinely in the clinic for visits 3 months after surgery. Additional X-rays will be taken at the 2-year follow up to ]
    Examination of implants, the degree of mobility of operated segments, subsidence and fusion

  33. Register data for care use. To measure/monitor care use [ Time Frame: Change from baseline to 3 months (the end of treatment) and 24 months follow-up ]
    Care use

  34. MRI may be measured in a sub-group [ Time Frame: Change from baseline to 3 months follow-up ]
    Neck muscle structure and maybe function

  35. Ultrasound registrations may be measured in a sub-group, deformation and deformation rate [ Time Frame: Change from baseline to 3 months follow-up ]
    Neck muscle function

  36. Global rating of change scale [ Time Frame: Change from baseline to 3 and 24 months follow-ups, measured at follow-ups ]
    Overall change because of the treatment


Other Outcome Measures:
  1. Background data such as age and gender [ Time Frame: Baseline ]
    Background data such as age, gender, living circumstances and earlier care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria for each surgical department:

• Record data in Swespine

Inclusion criteria for surgery:

  • Cervical disc disease, confirmed by MRI data compatible with clinical findings (neurological examination performed by neck surgeon i.e. neurosurgeon/orthopaedic surgeon) that show nerve root compression in the cervical spine.
  • Radiculopathy with pain in one or both arms, with or without sensory and/or motor deficit
  • At least 3 months of persistent arm pain

Inclusion criteria for the study:

  • ACDF due to cervical disc disease (disc herniation with or without osteophytes, or stenosis caused by osteophytes) in one or two segmental levels
  • Aged 18-75 years
  • Residual disability (approximately) 3 months after surgery (at the re-visit to the surgeon/ physiotherapist at the neurosurgery/ neuroorthopedic clinic) in terms of the Neck Disability Index (NDI ≥30%).
  • Access to a computer/tablet/smartphone and the Internet
  • Motivated to exercise

Exclusion Criteria:

Exclusion criteria:

  • Myelopathy
  • Previous fracture or dislocation of the cervical spine
  • Malignancy or benign spinal tumour (e.g. neuromas)
  • Spinal infection, ongoing post-operative infection, or previous spondylodiscitis
  • Previous cervical spine surgery
  • Factors that are contraindicated for study participation or which hinder treatment or follow-up because of systemic disease, physical or mental illness, injury, inconvenience, or postoperative complications.
  • Known alcohol/drug abuse
  • Lack of ability to write/comprehend/or express oneself in the Swedish language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036007


Contacts
Contact: Anneli Peolsson, Professor +46-13284601 Anneli.Peolsson@liu.se
Contact: Håkan Löfgren, PhD, MD +46-102410000 Hakan.Lofgren@rjl.se

Locations
Sweden
Anneli Peolsson Recruiting
Linköping, Östergötland, Sweden, SE-58183
Contact: Anneli Peolsson, Assoc. Prof.    +46-101031798    Anneli.Peolsson@liu.se   
Contact: Gunnel Peterson, MSc    +46-722100901    Gunnel.Peterson@liu.se   
Principal Investigator: Anneli Peolsson, Assoc.Prof.         
Sub-Investigator: Gunnel Peterson, MSc         
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Anneli Peolsson, Professor Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden

Responsible Party: Anneli Peolsson, Professor, PhD, PT, Linkoeping University
ClinicalTrials.gov Identifier: NCT03036007     History of Changes
Other Study ID Numbers: 2016 / 283-31
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anneli Peolsson, Linkoeping University:
Spine, Disc, Neck pain, Rehabilitation, Exercise Therapy, Internet

Additional relevant MeSH terms:
Radiculopathy
Intervertebral Disc Displacement
Intervertebral Disc Degeneration
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical