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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01825460
Other study ID # UAL-326
Secondary ID
Status Completed
Phase N/A
First received March 27, 2013
Last updated September 22, 2013
Start date April 2013
Est. completion date September 2013

Study information

Verified date May 2013
Source Universidad de Almeria
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria:

- To met Quebec Task Force Classification of WAD II- neck pain symptoms and musculoskeletal signs.

- No evidence of conduction loss on clinical neurological examination.

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Adelaida María Castro-Sánchez Almeria

Sponsors (3)

Lead Sponsor Collaborator
Universidad de Almeria Universidad de Granada, Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

References & 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Isabel de-la-Llave-Rincón A, Puentedura EJ, Fernández-de-Las-Peñas 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. At baseline and 2 weeks No
Secondary 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. At baseline and 2 weeks No
Secondary Tampa scale for kinesiophobia The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury. At baseline and 2 weeks No
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