Whiplash InjuriesNCT03502928
Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
A study testing Manual Therapy and Dry Needling in people with Whiplash Injuries, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- Manual Therapy and Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2019to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical Diagnosis of Whiplash Grade I-II in the QTF
- Neck Pain
- Whiplash in Acute or Subacute Phase
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Conditions
- Whiplash Injuries
- Being tested
- Motor Control, Manual Therapy, Dry Needling
- Keywords
- Dry Needling, Manual Therapy, Motor Control, Whiplash
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor ControlOther
Neck Motor Control
Manual TherapyOther
Massage + Joint Mobilizations
Dry NeedlingOther
Dry Needling in Neck Muscles
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Motor Control + Manual Therapy Receives: Other: Motor Control; Other: Manual Therapy |
| Experimental Treatment | Experimental | Motor Control + Manual Therapy + Dry Needling Receives: Other: Motor Control; Other: Manual Therapy; Other: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index. Changes from Baseline
0-100% (0% = No Disability; 100% = Disability (highest level of disability)
Measured: 3 weeks, 6 weeks, 3 months
Secondary outcomes (4)
Pressure pain thresholds. Changes from Baseline
The minimum force applied which induces pain. Measured kg/cm2
Measured: 3 weeks, 6 weeks, 3 months
Cervical Range of Movement. Changes from Baseline
Amount of cervical movement using a goniometer
Measured: 3 weeks, 6 weeks, 3 months
Kinesophobia. Changes from Baseline
Fear of movement measured by the TAMPA scale
Measured: 3 weeks, 6 weeks, 3 months
Cervical Motor Control. Changes from Baseline
measure of cervical joint position sense using a laser
Measured: 3 weeks, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start4 Nov 2019
- Primary completion16 Jan 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Lorenzo Moreno, University of Alcala
- Investigators
- Alexander Achalandabaso, PhD, Study director, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502928
- Sponsor's protocol ID
- 1489327794181094
- Status last verified
- Jun 2020
- First submitted
- 5 Apr 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
- ClinicalTrials.gov ID
- NCT03502928
- Acronym / sponsor ID
- 1489327794181094
- Conditions
- Whiplash Injuries
- Keywords
- Dry Needling, Manual Therapy, Motor Control, Whiplash
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | Active comparator | Other: Motor Control, Other: Manual TherapyMotor Control + Manual Therapy |
| Experimental Treatment | Experimental | Other: Motor Control, Other: Manual Therapy, Other: Dry NeedlingMotor Control + Manual Therapy + Dry Needling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical Diagnosis of Whiplash Grade I-II in the QTF
- Neck Pain
- Whiplash in Acute or Subacute Phase
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor ControlNeck Motor Control | Other | Conventional Treatment, Experimental Treatment |
| Manual TherapyMassage + Joint Mobilizations | Other | Conventional Treatment, Experimental Treatment |
| Dry NeedlingDry Needling in Neck Muscles | Other | Experimental Treatment |
Primary outcome
Neck Disability Index. Changes from Baseline
Time frame: 3 weeks, 6 weeks, 3 months
0-100% (0% = No Disability; 100% = Disability (highest level of disability)
4 secondary outcomes
Pressure pain thresholds. Changes from Baseline
Time frame: 3 weeks, 6 weeks, 3 months
Cervical Range of Movement. Changes from Baseline
Time frame: 3 weeks, 6 weeks, 3 months
Kinesophobia. Changes from Baseline
Time frame: 3 weeks, 6 weeks, 3 months
Cervical Motor Control. Changes from Baseline
Time frame: 3 weeks, 6 weeks, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Whiplash Injuries
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StressModex for Post-Traumatic Neck Pain
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Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
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Virtual Reality Rehabilitation in Neck Pain Subjects
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Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
Whiplash Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Achalandabaso, PhD study director
University of Jaén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Dry Needling in people with Whiplash Injuries, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index. Changes from Baseline (time frame: 3 weeks, 6 weeks, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.