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

• Sponsor: University of Alcala (Other)
• Overall Status: Completed
• CT.gov ID: NCT03502928
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 4.2

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Whiplash Injuries	Other: Motor Control; Other: Manual Therapy; Other: Dry Needling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of the Use of Dry Needling in Conventional Non-invasive Treatment of Acute and Subacute Whiplash
• Actual Study Start Date: Nov 4, 2019
• Actual Primary Completion Date: Jan 16, 2020
• Actual Study Completion Date: Jun 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Treatment Motor Control + Manual Therapy	Other: Motor Control; Neck Motor Control; Other: Manual Therapy; Massage + Joint Mobilizations
Experimental: Experimental Treatment Motor Control + Manual Therapy + Dry Needling	Other: Motor Control; Neck Motor Control; Other: Manual Therapy; Massage + Joint Mobilizations; Other: Dry Needling; Dry Needling in Neck Muscles

Outcome Measures

Primary Outcome Measures

1. Neck Disability Index. Changes from Baseline [3 weeks, 6 weeks, 3 months]

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

Secondary Outcome Measures

1. Pressure pain thresholds. Changes from Baseline [3 weeks, 6 weeks, 3 months]

   The minimum force applied which induces pain. Measured kg/cm2

2. Cervical Range of Movement. Changes from Baseline [3 weeks, 6 weeks, 3 months]

   Amount of cervical movement using a goniometer

3. Kinesophobia. Changes from Baseline [3 weeks, 6 weeks, 3 months]

   Fear of movement measured by the TAMPA scale

4. Cervical Motor Control. Changes from Baseline [3 weeks, 6 weeks, 3 months]

   measure of cervical joint position sense using a laser

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de Alcalá	Alcalá De Henares		Spain

Sponsors and Collaborators

• University of Alcala

Investigators

• Study Director: Alexander Achalandabaso, PhD, University of Jaén

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raquel Lorenzo Moreno, physiotherapist, University of Alcala
• ClinicalTrials.gov Identifier: NCT03502928
• Other Study ID Numbers: 1489327794181094
• First Posted: Apr 19, 2018
• Last Update Posted: Jun 11, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raquel Lorenzo Moreno, physiotherapist, University of Alcala: Dry Needling; Manual Therapy; Motor Control; Whiplash
• Additional relevant MeSH terms: Whiplash Injuries

Study Results

No Results Posted as of Jun 11, 2020