NCT03560947

Brief Summary

The aim of this study is to compare the effectiveness of a combined intervention of manual therapy and exercise versus usual care, on pain intensity, disability, and global perceived recovery, in patients with chronic nonspecific neck pain.

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 not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

May 23, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

May 23, 2018

Last Update Submit

June 15, 2018

Conditions

Chronic Nonspecific Neck Pain

Keywords

chronic nonspecific neck painexercisemanual therapy

Outcome Measures

Primary Outcomes (8)

  • Neck Pain Intensity

    Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

    Baseline

  • Neck Pain Intensity

    Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

    3 weeks

  • Neck Pain Intensity

    Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

    6 weeks

  • Neck Pain Intensity

    Measured using a Numeric Pain Rating Scale (range: 0 - 10 points)

    Follow-up 3 months

  • Neck Disability

    Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

    Baseline

  • Neck Disability

    Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

    3 weeks

  • Neck Disability

    Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

    6 weeks

  • Neck Disability

    Measured using the Neck Disability Index (range: 0-50 and higher scores are indicative of more disability)

    Follow-up 3 months

Secondary Outcomes (1)

  • Neck Global Perceived Recovery

    Change from baseline of the global perceived recovery at 3 weeks; 6 weeks; Follow-up 3 months

Study Arms (2)

Manual Therapy and Exercise

EXPERIMENTAL
Other: Manual Therapy and Exercise (Physiotherapy Intervention)

Usual Care

ACTIVE COMPARATOR
Other: Usual Care (Physiotherapy Intervention)

Interventions

Manual Therapy and Exercise (Physiotherapy Intervention)OTHER

Experimental group: Manual Therapy and Exercise Participants in this group will receive a 6-weeks program of mobilization and progressive exercise programme for the neck flexors, 2 times a week.

Manual Therapy and Exercise
Usual Care (Physiotherapy Intervention)OTHER

Active Comparator: Usual Care Participants in this group will receive usual care in physiotherapy during the 6-weeks period.

Usual Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis;
  • Adults between 18 and 65 years of age and literate in Portuguese;

You may not qualify if:

  • History of cervical trauma and/or history of surgery in the prior 6 months;
  • Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases;
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Musculoskeletal ManipulationsExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lúcia Domingues, M.Sc.

    NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lúcia Domingues, M.Sc.

CONTACT

00351967648456lucia.domingues@nms.unl.pt

Lúcia Domingues, M.Sc.

CONTACT

00351967648456

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 18, 2018

Study Start

June 20, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 18, 2018

Record last verified: 2018-06