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RecruitingNCT05310578Updated Sep 2, 2026

Functioning in Individuals With Cervical Radiculopathy After Posterior Cervical Decompression

An observational study in Cervical Radiculopathy, sponsored by Linkoeping University. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Linkoeping University · Observational

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
154
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Compression on structures, as spinal nerves, in the cervical spine can cause cervical radiculopathy which leads to pain, disability, and reduced quality of life for the affected individual. Cervical foraminotomy with our without laminectomy are common posterior decompression surgical techniques for treating cervical radiculopathy. There is a lack of knowledge regarding function in patients with cervical radiculopathy after posterior cervical decompression.

The aim with this study is to study pain, function, psychosocial factors, and health related quality of life after posterior cervical decompression in patients with cervical radiculopathy.

This is a prospective multicenter longitudinal observational cohort study with follow-up at three, 12- and 24 months postoperative. A total of 154 individuals scheduled to undergo foraminotomy with our without laminectomy due to cervical radiculopathy will be included. Primary outcome is neck-specific function measured with the Neck Disability Index. Data will be collected preoperatively and at three, 12 and 24 months with electronic questionnaire.

02

Conditions studied

  • Cervical Radiculopathy

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03

In context

Radiculopathy

483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.

This study's planned enrollment of 154 is above the median of 100 across 95 observational studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Linkoeping University is the lead sponsor of 193 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Individuals with cervical radiculopathy scheduled to undergo foraminotomy with our without laminectomy at one of three specific neurosurgery or neuroortopedic clinics in south of Sweden. Individuals are preoperative screened for eligibility and those who meet the criteria to participate in the study are asked for informed consent.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Cervical radiculopathy, confirmed by MRI images (or alternative neuroradiological imaging if MRI ) compatible with clinical findings of nerve root compression (neurological examination performed by a neurosurgeon/orthopedic surgeon)
  • Posterior cervical decompression as foraminotomy with our without laminectomy
  • At least 3 months of persistent arm pain
  • Age 18-75 years

Exclusion criteria

Exclusion Criteria:

  • Nurick score 2 or more (to exclude individuals with moderate to high myelopathy)
  • Previous surgery of cervical spine
  • Previous fracture or dislocation of the cervical spine
  • or benign spinal tumor (eg, neuromas)
  • Spinal infection
  • Previous spondylodiscitis
  • Servere mental disorder
  • Known alcohol or drug abuse
  • Lack of ability to write/comprehend/express oneself in Swedish
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
154 participants (estimated)
Patient registry
No

Interventions

  • ProcedurePosterior cervical foraminotomy (with our without laminectomy)

    The aim of surgery is to decrease the compression of the affected nerve. In posterior cervical foraminotomy, the foramina is expanded to create more space and with posterior cervical laminectomy the lamina is removed to create space mainly for the spinal cord.

06

What researchers measure

Primary outcomes

  1. Neck DisabiIity Index; 0-100% (0% = No disability)

    To measure neck-specific disability

    Time frame: Change from baseline to 24 months postoperatively

Secondary outcomes

  1. Numeric Rating Scale; 0-10 (0 = No pain/dizziness)

    To measure pain intensity in neck, arm and head; Dizziness and unsteadiness

    Time frame: Change from baseline to 24 months postoperatively

  2. Frequency of symptoms (5-grade scale from never to always)

    To measure frequency of symptoms including neck pain, neck stiffness, headache, arm pain, impaired arm function, dizziness, sleeping problems, visual disturbances, hearing disturbances, difficulty swallowing and chewing, nausea, and problems concentrating.

    Time frame: Change from baseline to 24 months postoperatively

  3. Specific questions regarding headache and dizziness

    To find out more about specific symptoms such as headaches and dizziness

    Time frame: Change from baseline to 24 months postoperatively

  4. Dizziness Handicap Inventory Scale; 0-100 (0 = no disability)

    To measure self-perceived impact on daily life due to dizziness and/or unsteadiness

    Time frame: Change from baseline to 24 months postoperatively

  5. Short Form Headache Impact test; 36-78 (36 = no impact)

    To measure impact of headache in daily life

    Time frame: Change from baseline to 24 months postoperatively

  6. Core outcome measure Index for neck; 0-10 (0 = good function)

    To measure patient self-perceived outcome of spinal surgery

    Time frame: Change from baseline to 24 months postoperatively

  7. Patient derived Modified Japanese Orthopeadic Association; 0-18 (18 = normal/no myelopathy).

    To measure the impact of myelopathy

    Time frame: Change from baseline to 24 months postoperatively

  8. Odom; 7-point scale (restored/much better to much worse)

    To measure global perceived effect

    Time frame: Change from baseline to 24 months postoperatively

  9. Global rating of change scale; 11 points scale (-5 - 5 where 5 indicates restored).

    To measure self-perceived effect

    Time frame: Change from baseline to 24 months postoperatively

  10. Fear Avoidance Beliefs Questionnaire; 0-96 (0 = no fear).

    To measure patients' beliefs about how physical activity and work affect their neck pain

    Time frame: Change from baseline to 24 months postoperatively

  11. Pain Catastrophizing Scale; 0-52 (0 = no catastrophizing)

    To measure catastrophizing

    Time frame: Change from baseline to 24 months postoperatively

  12. Self-Efficacy Scale; 0-200 (0 = low Self-Efficacy)

    To measure confidence in one's own ability

    Time frame: Change from baseline to 24 months postoperatively

  13. Hospital Anxiety and Depression Scale; 0- 42 (0 = indicates no depression and anxiety)

    To measure depression and anxiety

    Time frame: Change from baseline to 24 months postoperatively

  14. Question regarding expectations of surgery; 4 point scale (restored to no expectation to be restored)

    To find out more about expectations of surgery

    Time frame: Change from baseline to 24 months postoperatively

  15. Cherkin symptom satisfaction

    To measure expectations met and satisfaction with care

    Time frame: Change from baseline to 24 months postoperatively

  16. EuroQuol 5D-5L; 5-25 (5 = high health related quality of life)

    To measure health-related quality of life

    Time frame: Change from baseline to 24 months postoperatively

  17. EQ thermometer; 0-100 (0 = low health related quality of life)

    To measure health-related quality of life

    Time frame: Change from baseline to 24 months postoperatively

  18. Level of physical activity measured with a numeric rating; 1-4 (1 = inactivity - 4 high activity)

    To find out more about level of physical activity

    Time frame: Change from baseline to 24 months postoperatively

  19. International Physical Activity Questionnaire short version (categorize to low, moderate and high activity level)

    To measure level of physical activity

    Time frame: Change from baseline to 24 months postoperatively

  20. Work Ability Index (categorize to poor, moderate, good and excellent work ability)

    To measure self-rated work ability

    Time frame: Change from baseline to 24 months postoperatively

07

Study locations

3 of 3 sites recruiting
  • Neuro-ortopediska kliniken
    Jönköping, Sweden
    Recruiting
    • Håkan Löfgren · Contact
  • Neurosurgery clinic
    Linköping, Sweden
    Recruiting
    • Jard Svensson · Contact
  • Ryggkirurgiskt Centrum
    Stockholm, Sweden
    Recruiting
    • Martin Skeppholm · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05310578
Responsible party
Jard Svensson (Physiotherapist, Linkoeping University) — Principal investigator
First posted
Apr 5, 2022
Start date
Aug 22, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Jard Svensson, MSc
Contact
jard.svensson@liu.se
+46101034026
Anneli Peolsson, PhD
principal investigator · Linköping University, Department of Health, Medicine and Caring Sciences, Unit of physiotherapy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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