NCT02692937

Brief Summary

The purpose of this study is to compare the effects of neurolysis with the effects of a exercise program on pain and other symptoms in individuals with chronic whiplash (WAD II-III).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

6.2 years

First QC Date

February 15, 2016

Last Update Submit

April 3, 2020

Conditions

Whiplash Injuries

Keywords

Neurosurgical ProceduresNerve BlockExercise therapyPhysical Therapy Specialty

Outcome Measures

Primary Outcomes (1)

  • The Neck Disability Index (NDI)

    Questionnaire

    24 months

Secondary Outcomes (11)

  • The Symptom index

    24 months

  • Self-Efficacy Scale (SES)

    24 months

  • Headache Disability Index (HDI)

    24 months

  • Whiplash Associated Disorders - Disability Index (WAD-DI)

    24 months

  • Zung Self-Rating Depression Scale (Zung)

    24 months

  • +6 more secondary outcomes

Study Arms (2)

Surgery and exercise

EXPERIMENTAL

Neurolysis of peripheral nerves in the back of the head and/or neck. Traditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months.

Procedure: NeurolysisOther: Traditional neck-specific exercise program

Exercise, Active Comparator

ACTIVE COMPARATOR

Traditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months.

Other: Traditional neck-specific exercise program

Interventions

NeurolysisPROCEDURE
Surgery and exercise
Traditional neck-specific exercise programOTHER
Exercise, Active ComparatorSurgery and exercise

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • trauma that has caused a whiplash injury
  • at least one year of incapacitating chronic neck pain/headache related to the injury (WAD II-III)
  • typical trigger points in the back of the head or in the neck and significant pain relief with local anesthesia towards the painful areas

You may not qualify if:

  • mental illness
  • abuse of drugs/alcohol
  • not understanding or reading the Swedish language
  • previous surgery in the back of the head

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Department of Neurosurgery, Skåne University Hospital

Lund, Skåne County, 22185, Sweden

Location

MeSH Terms

Conditions

Whiplash Injuries

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Leif Anderberg, MD, PhD

    The Department of Neurosurgery, Skåne University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 26, 2016

Study Start

January 1, 2011

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations

SE(1)