Back to resultsEfficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
Primary Purpose
Whiplash Injuries
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Motor Control
Manual Therapy
Dry Needling
Sponsored by
About this trial
This is an interventional treatment trial for Whiplash Injuries focused on measuring Dry Needling, Manual Therapy, Motor Control, Whiplash
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
Sites / Locations
- Universidad de Alcalá
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Treatment
Experimental Treatment
Arm Description
Motor Control + Manual Therapy
Motor Control + Manual Therapy + Dry Needling
Outcomes
Primary Outcome Measures
Neck Disability Index. Changes from Baseline
0-100% (0% = No Disability; 100% = Disability (highest level of disability)
Secondary Outcome Measures
Pressure pain thresholds. Changes from Baseline
The minimum force applied which induces pain. Measured kg/cm2
Cervical Range of Movement. Changes from Baseline
Amount of cervical movement using a goniometer
Kinesophobia. Changes from Baseline
Fear of movement measured by the TAMPA scale
Cervical Motor Control. Changes from Baseline
measure of cervical joint position sense using a laser
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03502928
Brief Title
Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
Official Title
Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries
Keywords
Dry Needling, Manual Therapy, Motor Control, Whiplash
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm Description
Motor Control + Manual Therapy
Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Motor Control + Manual Therapy + Dry Needling
Intervention Type
Other
Intervention Name(s)
Motor Control
Intervention Description
Neck Motor Control
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Massage + Joint Mobilizations
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
Dry Needling in Neck Muscles
Primary Outcome Measure Information:
Title
Neck Disability Index. Changes from Baseline
Description
0-100% (0% = No Disability; 100% = Disability (highest level of disability)
Time Frame
3 weeks, 6 weeks, 3 months
Secondary Outcome Measure Information:
Title
Pressure pain thresholds. Changes from Baseline
Description
The minimum force applied which induces pain. Measured kg/cm2
Time Frame
3 weeks, 6 weeks, 3 months
Title
Cervical Range of Movement. Changes from Baseline
Description
Amount of cervical movement using a goniometer
Time Frame
3 weeks, 6 weeks, 3 months
Title
Kinesophobia. Changes from Baseline
Description
Fear of movement measured by the TAMPA scale
Time Frame
3 weeks, 6 weeks, 3 months
Title
Cervical Motor Control. Changes from Baseline
Description
measure of cervical joint position sense using a laser
Time Frame
3 weeks, 6 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Achalandabaso, PhD
Organizational Affiliation
University of Jaén
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Alcalá
City
Alcalá De Henares
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
We'll reach out to this number within 24 hrs