NCT03992495

Brief Summary

This study investigates the effect of exercise on pain sensitivity in ongoing neck pain patients compared to a healthy control group.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 20, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 18, 2019

Last Update Submit

June 19, 2019

Conditions

Keywords

ExerciseNeck painPain sensitivity

Outcome Measures

Primary Outcomes (1)

  • Change in pain sensitivity

    Pain sensitivity will be estimated by determining the pressure pain threshold (PPT) on the neck before and after exercise

    Baseline, 6 weeks, 12 weeks

Secondary Outcomes (2)

  • Change in perceived pain

    Baseline, 6 weeks, 12 weeks

  • Change in disability

    Baseline, 6 weeks, 12 weeks

Other Outcomes (1)

  • Change in body movements

    Baseline, 6 weeks, 12 weeks

Study Arms (2)

Neck pain

People suffering from neck pain at the time of recruitment

Other: Exercise

Healthy

Participants with no significant past neck pain, chronic pain or other relevant medical disorders.

Other: Exercise

Interventions

All participants will be exposed to aerobic/strengthening exercises

HealthyNeck pain

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People with self-reported pain from the neck area with a symptom duration of three months or longer and pain free healthy participants.

You may qualify if:

  • Pain free healthy participants
  • Able to speak, read and understand Danish and English

You may not qualify if:

  • Pain from the neck or shoulder area during the past 6 months
  • Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
  • Former surgery in neck or shoulder
  • Current or previous chronic or recurrent pain condition
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Regular use of analgesics
  • Abnormally disrupted sleep in the last 24 hours preceding the experiment
  • Lack of ability to cooperate
  • Self reported neck pain lasting three months or longer.
  • Able to speak, read and understand Danish and English
  • Shoulder pain during arm movements
  • Experience of DOMS during the week leading up to the test session
  • Former surgery in neck or shoulder
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Steffan W Christensen, PhD

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffan W Christensen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

June 20, 2019

Primary Completion

October 1, 2020

Study Completion

January 1, 2021

Last Updated

June 20, 2019

Record last verified: 2019-06