AzTrials
AzTrials

Whiplash InjuriesNCT01825460

Manual Therapy to Treat Acute Whiplash Injury

A study testing Manual Therapy Protocol and Two manual techniques in people with Whiplash Injuries, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 50 years
Conditions the study is for
Whiplash Injuries
What is being tested?
Manual Therapy Protocol and Two manual techniques
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
Apr 2013to Sep 2013
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 25 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Headaches
  • Psychiatric or psychologic condition
  • Neurologic or circulatory disorders

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Adelaida María Castro-Sánchez

    Almería, Almeria, 04120

Other trials in Spain

About this study

Official title: Short-Term Effects of a Manual Therapy Protocol

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.

Read the detailed description

Design: Randomized clinical trial. Objectives: to determine the short-term effects of a a manual therapy protocol on pain, disability and cervical range of motion in individuals with acute whiplash injury.

Methods and measures: sixty patients will be randomly assigned to 1 of 2 groups: the experimental group received a manual therapy protocol and the placebo group received two manual therapy techniques. Neck pain, disability and cervical range of motion data will be collected at baseline and 24-hr after the last manual therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome variable.

Being tested
Manual Therapy Protocol, Two manual techniques
Keywords
Cervical spine, Neck pain, Manual therapy, Controlled clinical trial
Medical subject headings
Whiplash Injuries, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Two manual techniquesOther

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

Study groups in NCT01825460
Study groupRoleWhat they receive
Manual Therapy ProtocolExperimentalA protocol with five techniques on thoracic area applied twice a week.
Receives: Other: Manual Therapy Protocol
Two manual techniquesActive comparatorTwo manual therapies on thoracic area applied twice a week.
Receives: Other: Two manual techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change on Numerical Pain Rating Scale

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

    Measured: At baseline and 2 weeks

Secondary outcomes (3)

  1. Neck disability index

    The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache.

    Measured: At baseline and 2 weeks

  2. Cervical Range of Motion

    Cervical range of motion is assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90º of flexion, and buttocks positioned against the back of the chair.

    Measured: At baseline and 2 weeks

  3. Tampa scale for kinesiophobia

    The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.

    Measured: At baseline and 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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
Single group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01825460
Sponsor's protocol ID
UAL-326
Status last verified
May 2013
First submitted
27 Mar 2013
Last updated
24 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23465963

  • 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.

    PubMed 23432939

  • 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.

    PubMed 23295018

  • 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.

    PubMed 23115473

  • 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.

    PubMed 22959229

  • 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.

    PubMed 22947552

  • 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.

    PubMed 22464187

  • 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.

    PubMed 21955671

  • 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.

    PubMed 21796089

  • 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.

    PubMed 21406332

  • 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.

    PubMed 21367648

  • 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.

    PubMed 21295511

  • 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.

    PubMed 21256074

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy Protocol and Two manual techniques in people with Whiplash Injuries, run by Universidad de Almeria 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 2 inclusion and 9 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 24 Sep 2013. 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?

Change on Numerical Pain Rating Scale (time frame: At baseline and 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01825460, which also lists 13 linked publications.

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 24 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in