Efficacy of the Use of Dry Needling in Conventional Non-i... | NCT03502928

Studies
Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash

NCT03502928

Sponsor

University of Alcala

Status

Completed

Last Update Posted

Jun 11, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Whiplash Injuries

Interventions

Motor Control
Manual Therapy
Dry Needling

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2019Actual

Primary Completion Date

Jan 16, 2020Actual

Completion Date

Jun 10, 2020Actual

First Submitted Date

Apr 5, 2018

First Submission Date that Met QC Criteria

Apr 17, 2018

First Posted Date

Apr 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2020

Last Update Posted Date

Jun 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Raquel Lorenzo Moreno, physiotherapist, University of AlcalaPrincipal Investigator

Lead Sponsor

University of AlcalaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional Treatment	Active Comparator	Motor Control + Manual Therapy	Other: Motor Control Other: Manual Therapy
Experimental Treatment	Experimental	Motor Control + Manual Therapy + Dry Needling	Other: Motor Control Other: Manual Therapy Other: Dry Needling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motor Control	Other	Neck Motor Control	Conventional Treatment Experimental Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pressure pain thresholds. Changes from Baseline	The minimum force applied which induces pain. Measured kg/cm2	3 weeks, 6 weeks, 3 months
Cervical Range of Movement. Changes from Baseline	Amount of cervical movement using a goniometer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander Achalandabaso, PhD	University of Jaén	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de Alcalá		Alcalá de Henares			Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014911	Whiplash Injuries

Ancestor Terms

ID	Term
D019838	Neck Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007839	Functional Laterality
D026201	Musculoskeletal Manipulations
D000079245	Dry Needling

Ancestor Terms

ID	Term
D004292	Dominance, Cerebral
D009424	Nervous System Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena
D000529	Complementary Therapies

Browse Leaves

Not provided

Browse Branches

Not provided