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Physiotherapy After Anterior Cervical Spine Surgery

NCT03036007 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-20

No results posted yet for this study

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

Interventions

OTHER

Prescribed Physical Activity

General physical activity prescribed by a physiotherapist

OTHER

Exercises with Internet support

Neck-specific exercise with Internet support

Sponsors & Collaborators

  • Linkoeping University

    lead OTHER_GOV

Principal Investigators

  • Anneli Peolsson, Professor · Dep. Medical and Health Sciences, Physiotherapy, Linköping University, Linköping, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2024-12-31
Completion
2025-01-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03036007 on ClinicalTrials.gov