Physiotherapy After Anterior Cervical Spine Surgery

NCT03036007 | Active Not Recruiting

• 1 other identifier: 2016 / 283-31
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Disc Disease; Radiculopathy, Cervical

Keywords

Spine, Disc, Neck pain, Rehabilitation, Exercise Therapy, Internet

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI)

  Self-reported neck-specific function

  Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Preoperative data from the Swespine register

Secondary Outcomes (36)

• Pain intensities of the neck, arm, and head, measured using the Visual Analogue Scale (VAS 0-100 mm).

  Change from baseline to 3 months (the end of treatment) and 24 months follow-up. Pre-operative data from the Swespine register

• 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

  Change from baseline to 3 months (the end of treatment) and 24 months follow-up

• Distribution of pain by a Pain Drawing assessed with images

  Change from baseline to 3 months (the end of treatment) and 24 months follow-up

• Use of pain medications

  Change from baseline to 3 months (the end of treatment) and 24 months follow-up

• Modified Odom

  Change from baseline to 3 months (the end of treatment) and 24 months follow-up

Other Outcomes (1)

• Background data such as age and gender

  Baseline

Study Arms (2)

Prescribed Physical Activity

ACTIVE COMPARATOR

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

Exercises with Internet support

EXPERIMENTAL

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

Interventions

Prescribed Physical Activity OTHER

General physical activity prescribed by a physiotherapist

Prescribed Physical Activity

Exercises with Internet support OTHER

Neck-specific exercise with Internet support

Exercises with Internet support

Eligibility Criteria

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

You may qualify if:

• Record data in Swespine
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Anneli Peolsson

Linköping, Östergötland County, SE-58183, Sweden

Location

Related Publications (1)

• Peolsson A, Peterson G, Hermansen A, Ludvigsson ML, Dedering A, Lofgren H. Physiotherapy after anterior cervical spine surgery for cervical disc disease: study protocol of a prospective randomised study to compare internet-based neck-specific exercise with prescribed physical activity. BMJ Open. 2019 Feb 19;9(2):e027387. doi: 10.1136/bmjopen-2018-027387.

  PMID: 30782952 DERIVED

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anneli Peolsson, Professor

  Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD, PT

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 30, 2017
• Study Start: May 22, 2017
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)