NCT03502928

Brief Summary

INTRODUCTION: Whiplash is an injury produced by an acceleration-deceleration mechanism that transmits energy to the cervical spine. According to the bibliography, the conservative treatment (motor control exercises and manual therapy) has shown benefits in approaching this lesion, but its efficacy is limited. Dry needling has already shown its usefulness in different musculoskeletal pathologies, however, its efficacy is unknown when it is included in conservative treatment. OBJECTIVES: The objective of this study is to assess the effects of the incorporation of dry needling in the conventional treatment with manual therapy and motor control exercises, compared to the conventional non-invasive treatment in patients with acute or subacute whiplash. HYPOTHESIS: The inclusion of dry needling in conventional non-invasive treatment is more effective than conventional non-invasive treatment in patients with acute or subacute whiplash. METHODS: A randomized clinical trial will be conducted in which the subjects of study will be assigned to two groups, a control group (conventional treatment) and an experimental group (conventional treatment and dry needling).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

April 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

April 5, 2018

Last Update Submit

June 10, 2020

Conditions

Keywords

Dry NeedlingManual TherapyMotor ControlWhiplash

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index. Changes from Baseline

    0-100% (0% = No Disability; 100% = Disability (highest level of disability)

    3 weeks, 6 weeks, 3 months

Secondary Outcomes (4)

  • Pressure pain thresholds. Changes from Baseline

    3 weeks, 6 weeks, 3 months

  • Cervical Range of Movement. Changes from Baseline

    3 weeks, 6 weeks, 3 months

  • Kinesophobia. Changes from Baseline

    3 weeks, 6 weeks, 3 months

  • Cervical Motor Control. Changes from Baseline

    3 weeks, 6 weeks, 3 months

Study Arms (2)

Conventional Treatment

ACTIVE COMPARATOR

Motor Control + Manual Therapy

Other: Motor ControlOther: Manual Therapy

Experimental Treatment

EXPERIMENTAL

Motor Control + Manual Therapy + Dry Needling

Other: Motor ControlOther: Manual TherapyOther: Dry Needling

Interventions

Neck Motor Control

Conventional TreatmentExperimental Treatment

Massage + Joint Mobilizations

Conventional TreatmentExperimental Treatment

Dry Needling in Neck Muscles

Experimental Treatment

Eligibility Criteria

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

You may qualify if:

  • Medical Diagnosis of Whiplash Grade I-II in the QTF
  • Neck Pain
  • Whiplash in Acute or Subacute Phase

You may not qualify if:

  • Pregnancy
  • Belonephobia
  • Cervical Fractures-Dislocations or Neurological Deficit Secondaries to Accident
  • Previous Surgery of the Cervical Spine
  • Circulatory Disease, Respiratory Disease, Neurological Disease, Rheumatologic Disease and Mental Illness
  • Athletes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Alcalá

Alcalá de Henares, Spain

Location

MeSH Terms

Conditions

Whiplash Injuries

Interventions

Functional LateralityMusculoskeletal ManipulationsDry Needling

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Dominance, CerebralNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Alexander Achalandabaso, PhD

    University of Jaén

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 19, 2018

Study Start

November 4, 2019

Primary Completion

January 16, 2020

Study Completion

June 10, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations