Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
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
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 19, 2018
CompletedStudy Start
First participant enrolled
November 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2020
CompletedJune 11, 2020
June 1, 2020
2 months
April 5, 2018
June 10, 2020
Conditions
Keywords
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 COMPARATORMotor Control + Manual Therapy
Experimental Treatment
EXPERIMENTALMotor Control + Manual Therapy + Dry Needling
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexander Achalandabaso, PhD
University of Jaén
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