Cervical Radiculopathy Trial

NCT03674619 | Active Not Recruiting

• 1 other identifier: 2017/2125
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the present project is to compare the effectiveness of surgery and nonsurgical treatment in patients with cervical radiculopathy caused by either disc herniation or spondylosis. Secondary aims are to evaluate cost-effectiveness and predicting factors of success of the two treatments, and to explore the terms success rate and expectations by asking the patients to fill in their expected primary outcome score at baseline.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index

  Consists of ten questions about pain related disability and include items such as by example headache, concentration, reading and sleep. Each item is rated by choosing one of five response categories and transformed to a total score from 0 to 100 (worst possible). The Norwegian version has been validated in patients with neck pain and with cervical radiculopathy.

  Follow-up at 52 weeks is the primary end point.

Secondary Outcomes (11)

• Neck pain

  52 weeks

• EuroQol (EQ-5D-5L and EQ-VAS)

  52 weeks

• Fear-avoidance beliefs

  52 weeks

• Emotional distress

  52 weeks

• Perceived recovery

  52 weeks

Study Arms (2)

Surgical treatment

ACTIVE COMPARATOR

Anterior discectomy

Procedure: Anterior discectomy

Conservative treatment

ACTIVE COMPARATOR

Patients will attend an experienced specialist in physical medicine and rehabilitation and a physiotherapist.

Behavioral: Conservative treatment

Interventions

Anterior discectomy PROCEDURE

Anterior discectomy will be performed and a microscope is used. After separation of the platysma muscle the pre-vertebral space is reached by an approach medial to the sternocleido-mastoid muscle and the carotid artery and lateral to the trachea and oesophagus. Then the disc is incided and the corpora are distracted to perform discectomy. Usually the posterior ligament is cut and the spinal root is decompressed and if necessary the arthritic rims are removed. An inter-vertebral fusion device is inserted, two levels are allowed in the spondylosis study.

Surgical treatment

Conservative treatment BEHAVIORAL

Patients will first attend an experienced specialist in physical medicine and rehabilitation who will answer concerns and questions and if necessary repeat the information given before inclusion. The aim of the brief intervention is to promote better understanding and coping of the condition. The intervention will include supervision by a physiotherapist (6 sessions altogether) and provide advice on how to handle secondary neck muscle pain and dysfunction, reduce eventual fear avoidance, and advice to stay active.

Conservative treatment

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 65 years.
• Study 1: Neck and arm pain for at least 3 months with a corresponding herniation involving one cervical nerve root (C6 or C7) Study 2: Neck and arm pain for at least 3 months with a corresponding spondylosis involving C6 and/or C7) .
• Pain intensity of arm pain of at least 4 on a scale from 0 (no pain) to 10 (worst possible pain)
• Willing to accept either of the treatment alternatives
• NDI \> 30

You may not qualify if:

• Patients with any previous cervical fractures or cervical spine surgery;
• Signs of myelopathy;
• Rapidly progressive paresis or paresis \< grade 4;
• Pregnancy;
• Arthritis involving the cervical spine;
• Infection or active cancer;
• Generalised pain syndrome;
• Serious psychiatric or somatic disease that exclude one of the treatment alternatives;
• Concomitant shoulder disorders that may interfere with outcome;
• Abuse of medication/narcotics,
• Not able to understand written Norwegian,
• Not willing to accept one of the treatment alternatives.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (3)

• Taso M, Sommernes JH, Sundseth J, Pripp AH, Bjorland S, Engebretsen KB, Kolstad F, Zwart JA, Brox JI. Surgical versus Nonsurgical Treatment for Cervical Radiculopathy. NEJM Evid. 2025 Apr;4(4):EVIDoa2400404. doi: 10.1056/EVIDoa2400404. Epub 2025 Mar 25.

  PMID: 40130970 DERIVED

• Taso M, Sommernes JH, Bjorland S, Zwart JA, Engebretsen KB, Sundseth J, Pripp AH, Kolstad F, Brox JI. What is success of treatment? Expected outcome scores in cervical radiculopathy patients were much higher than the previously reported cut-off values for success. Eur Spine J. 2022 Oct;31(10):2761-2768. doi: 10.1007/s00586-022-07234-7. Epub 2022 May 13.

  PMID: 35551484 DERIVED

• Taso M, Sommernes JH, Kolstad F, Sundseth J, Bjorland S, Pripp AH, Zwart JA, Brox JI. A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy. BMC Musculoskelet Disord. 2020 Mar 16;21(1):171. doi: 10.1186/s12891-020-3188-6.

  PMID: 32178655 DERIVED

MeSH Terms

Conditions

Radiculopathy

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jens Ivar Brox, MD PhD

  Oslo University Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 17, 2018
• Study Start: October 19, 2018
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

NO (1)