Markus Engquist1, Håkan Löfgren, Birgitta Öberg, Anders Holtz, Anneli Peolsson, Anne Söderlund, Ludek Vavruch, Bengt Lind. 1. *Department of Orthopaedics, Ryhov Hospital, Jönköping, Sweden†Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden‡Neuro-Orthopedic Center, Ryhov Hospital, Jönköping, Sweden§Department of Medical and Health Sciences, Division of Physiotherapy, Faculty of Health Sciences, Linköping University, Linköping, Sweden¶Department of Neuroscience, Neurosurgery, Uppsala University Hospital, Uppsala, Sweden∥Department of Physiotherapy, School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden**Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; and††Spine Center Göteborg, Gothenburg, Sweden.
Abstract
STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: To analyze factors that may influence the outcome of anterior cervical decompression and fusion (ACDF) followed by physiotherapy versus physiotherapy alone for treatment of patients with cervical radiculopathy. SUMMARY OF BACKGROUND DATA: An understanding of patient-related factors affecting the outcome of ACDF is important for preoperative patient selection. No previous prospective, randomized study of treatment effect modifiers relating to outcome of ACDF compared with physiotherapy has been carried out. METHODS:60 patients with cervical radiculopathy were randomized to ACDF followed by physiotherapy or physiotherapy alone. Data for possible modifiers of treatment outcome at 1 year, such as sex, age, duration of pain, pain intensity, disability (Neck Disability Index, NDI), patient expectations of treatment, anxiety due to neck/arm pain, distress (Distress and Risk Assessment Method), self-efficacy (Self-Efficacy Scale) health status (EQ-5D), and magnetic resonance imaging findings were collected. A multivariate analysis was performed to find treatment effect modifiers affecting the outcome regarding arm/neck pain intensity and NDI. RESULTS: Factors that significantly altered the treatment effect between treatment groups in favor of surgery were: duration of neck pain less than 12 months (P = 0.007), duration of arm pain less than 12 months (P = 0.01) and female sex (P = 0.007) (outcome: arm pain), low EQ-5D index (outcome: neck pain, P = 0.02), high levels of anxiety due to neck/arm pain (outcome: neck pain, P = 0.02 and NDI, P = 0.02), low Self-Efficacy Scale score (P = 0.05), and high Distress and Risk Assessment Method score (P = 0.04) (outcome: NDI). No factors were found to be associated with better outcome with physiotherapy alone. CONCLUSION: In this prospective, randomized study of patients with cervical radiculopathy, short duration of pain, female sex, low health quality, high levels of anxiety due to neck/arm pain, low self-efficacy, and a high level of distress before treatment were associated with better outcome from surgery. No factors were found to be associated with better outcome from physiotherapy alone.
RCT Entities:
STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: To analyze factors that may influence the outcome of anterior cervical decompression and fusion (ACDF) followed by physiotherapy versus physiotherapy alone for treatment of patients with cervical radiculopathy. SUMMARY OF BACKGROUND DATA: An understanding of patient-related factors affecting the outcome of ACDF is important for preoperative patient selection. No previous prospective, randomized study of treatment effect modifiers relating to outcome of ACDF compared with physiotherapy has been carried out. METHODS: 60 patients with cervical radiculopathy were randomized to ACDF followed by physiotherapy or physiotherapy alone. Data for possible modifiers of treatment outcome at 1 year, such as sex, age, duration of pain, pain intensity, disability (Neck Disability Index, NDI), patient expectations of treatment, anxiety due to neck/arm pain, distress (Distress and Risk Assessment Method), self-efficacy (Self-Efficacy Scale) health status (EQ-5D), and magnetic resonance imaging findings were collected. A multivariate analysis was performed to find treatment effect modifiers affecting the outcome regarding arm/neck pain intensity and NDI. RESULTS: Factors that significantly altered the treatment effect between treatment groups in favor of surgery were: duration of neck pain less than 12 months (P = 0.007), duration of arm pain less than 12 months (P = 0.01) and female sex (P = 0.007) (outcome: arm pain), low EQ-5D index (outcome: neck pain, P = 0.02), high levels of anxiety due to neck/arm pain (outcome: neck pain, P = 0.02 and NDI, P = 0.02), low Self-Efficacy Scale score (P = 0.05), and high Distress and Risk Assessment Method score (P = 0.04) (outcome: NDI). No factors were found to be associated with better outcome with physiotherapy alone. CONCLUSION: In this prospective, randomized study of patients with cervical radiculopathy, short duration of pain, female sex, low health quality, high levels of anxiety due to neck/arm pain, low self-efficacy, and a high level of distress before treatment were associated with better outcome from surgery. No factors were found to be associated with better outcome from physiotherapy alone.