NCT01825460

Brief Summary

The purpose of this study is to determine the short-term effects of a manual therapy protocol on pain, disability and cervical range of motion in individuals with acute whiplash injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 24, 2013

Status Verified

May 1, 2013

Enrollment Period

5 months

First QC Date

March 27, 2013

Last Update Submit

September 22, 2013

Conditions

Whiplash Injuries

Keywords

Cervical spineNeck painManual therapyControlled clinical trial

Outcome Measures

Primary Outcomes (1)

  • Change on Numerical Pain Rating Scale

    The numerical pain rating scale is used to record the patient´s current level of neck pain.

    At baseline and 2 weeks

Secondary Outcomes (3)

  • Neck disability index

    At baseline and 2 weeks

  • Cervical Range of Motion

    At baseline and 2 weeks

  • Tampa scale for kinesiophobia

    At baseline and 2 weeks

Study Arms (2)

Manual Therapy Protocol

EXPERIMENTAL

A protocol with five techniques on thoracic area applied twice a week.

Other: Manual Therapy Protocol

Two manual techniques

ACTIVE COMPARATOR

Two manual therapies on thoracic area applied twice a week.

Other: Two manual techniques

Interventions

Manual Therapy ProtocolOTHER

The manual therapy protocol consists in the application of the following techniques: stretching diaphragm, Inhibition for phrenic center, Neuromuscular technique, technique jones and balance technique functional.

Manual Therapy Protocol
Two manual techniquesOTHER

The two manual techniques applied to control group are: inhibition for phrenic center and neuromuscular technique.

Two manual techniques

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To met Quebec Task Force Classification of WAD II- neck pain symptoms and musculoskeletal signs.
  • No evidence of conduction loss on clinical neurological examination.

You may not qualify if:

  • Concussion during the motor vehicle accident.
  • Loss of consciousness.
  • Head or upper quadrant injury during the accident.
  • Sought treatment prior to their accident for neck pain.
  • A previous history of whiplash
  • Neck pain
  • Headaches
  • Psychiatric or psychologic condition
  • Neurologic or circulatory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adelaida María Castro-Sánchez

Almería, Almeria, 04120, Spain

Location

Related Publications (13)

  • Elliott JM, Kerry R, Flynn T, Parrish TB. Content not quantity is a better measure of muscle degeneration in whiplash. Man Ther. 2013 Dec;18(6):578-82. doi: 10.1016/j.math.2013.02.002. Epub 2013 Mar 5.

    PMID: 23465963BACKGROUND

  • Smith J, Bolton PS. What are the clinical criteria justifying spinal manipulative therapy for neck pain?- a systematic review of randomized controlled trials. Pain Med. 2013 Apr;14(4):460-8. doi: 10.1111/pme.12041. Epub 2013 Feb 22.

    PMID: 23432939BACKGROUND

  • Humphreys BK, Peterson C. Comparison of outcomes in neck pain patients with and without dizziness undergoing chiropractic treatment: a prospective cohort study with 6 month follow-up. Chiropr Man Therap. 2013 Jan 7;21(1):3. doi: 10.1186/2045-709X-21-3.

    PMID: 23295018BACKGROUND

  • Isabel de-la-Llave-Rincon A, Puentedura EJ, Fernandez-de-Las-Penas C. Clinical presentation and manual therapy for upper quadrant musculoskeletal conditions. J Man Manip Ther. 2011 Nov;19(4):201-11. doi: 10.1179/106698111X13129729551985.

    PMID: 23115473BACKGROUND

  • Pedler A, Motlagh H, Sterling M. Laterality judgments are not impaired in patients with chronic whiplash associated disorders. Man Ther. 2013 Feb;18(1):72-6. doi: 10.1016/j.math.2012.07.006. Epub 2012 Sep 5.

    PMID: 22959229BACKGROUND

  • Stone AM, Vicenzino B, Lim EC, Sterling M. Measures of central hyperexcitability in chronic whiplash associated disorder--a systematic review and meta-analysis. Man Ther. 2013 Apr;18(2):111-7. doi: 10.1016/j.math.2012.07.009. Epub 2012 Sep 1.

    PMID: 22947552BACKGROUND

  • Goldsmith R, Wright C, Bell SF, Rushton A. Cold hyperalgesia as a prognostic factor in whiplash associated disorders: a systematic review. Man Ther. 2012 Oct;17(5):402-10. doi: 10.1016/j.math.2012.02.014. Epub 2012 Mar 29.

    PMID: 22464187BACKGROUND

  • Oddsdottir GL, Kristjansson E. Two different courses of impaired cervical kinaesthesia following a whiplash injury. A one-year prospective study. Man Ther. 2012 Feb;17(1):60-5. doi: 10.1016/j.math.2011.08.009. Epub 2011 Sep 28.

    PMID: 21955671BACKGROUND

  • Picelli A, Ledro G, Turrina A, Stecco C, Santilli V, Smania N. Effects of myofascial technique in patients with subacute whiplash associated disorders: a pilot study. Eur J Phys Rehabil Med. 2011 Dec;47(4):561-8. Epub 2011 Jul 28.

    PMID: 21796089BACKGROUND

  • Verhagen AP, Lewis M, Schellingerhout JM, Heymans MW, Dziedzic K, de Vet HC, Koes BW. Do whiplash patients differ from other patients with non-specific neck pain regarding pain, function or prognosis? Man Ther. 2011 Oct;16(5):456-62. doi: 10.1016/j.math.2011.02.009. Epub 2011 Mar 13.

    PMID: 21406332BACKGROUND

  • Stokell R, Yu A, Williams K, Treleaven J. Dynamic and functional balance tasks in subjects with persistent whiplash: a pilot trial. Man Ther. 2011 Aug;16(4):394-8. doi: 10.1016/j.math.2011.01.012. Epub 2011 Mar 1.

    PMID: 21367648BACKGROUND

  • Johansson MP, Baann Liane MS, Bendix T, Kasch H, Kongsted A. Does cervical kyphosis relate to symptoms following whiplash injury? Man Ther. 2011 Aug;16(4):378-83. doi: 10.1016/j.math.2011.01.004. Epub 2011 Feb 3.

    PMID: 21295511BACKGROUND

  • Yu LJ, Stokell R, Treleaven J. The effect of neck torsion on postural stability in subjects with persistent whiplash. Man Ther. 2011 Aug;16(4):339-43. doi: 10.1016/j.math.2010.12.006. Epub 2011 Jan 20.

    PMID: 21256074BACKGROUND

MeSH Terms

Conditions

Whiplash InjuriesNeck Pain

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adelaida M Castro-Sánchez, PhD

    Universidad de Almeria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD (Lecturer)

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 5, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 24, 2013

Record last verified: 2013-05

Locations

ES(1)