Cervical and Upper Thoracic Mobilization and Manipulation for Mechanical Neck Pain

NCT02036905 | Completed

• 1 other identifier: 181-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this pilot study is to determine the feasibility of a large-scale trial. The primary objective is to determine if manipulation applied to the cervical and thoracic spines is more effective than mobilization applied to the cervical and thoracic spines for the management of patients with mechanical neck pain.

Conditions

Neck Pain

Keywords

neck pain, orthopedic manual therapy

Outcome Measures

Primary Outcomes (1)

• Change in Neck Disability Index (NDI)

  The NDI is a reliable and valid outcome tool for patients with neck pain. It is a self-report measurement tool that was specifically constructed to measure the degree of disability for persons with neck pain. There are 10 total items that are ranked from 0-5 giving a total possible number of 50 points. The larger the score, the greater the disability for that individual.

  Initial evaluation, 2nd visit expected average day 3, and discharge expected average 4 weeks.

Secondary Outcomes (5)

• change in numeric pain rating scale (NPRS)

  initial evaluation, 2nd visit expected average day 3, discharge expected average 4 weeks

• Change in patient specific functional scale (PSFS)

  Initial evaluation, 2nd visit expected average day 3, and at discharge expected average 4 weeks.

• Change in the global rating of change

  after visit 2 (expected average day 3) and again at discharge expected average 4 weeks.

• Percent recovery

  Measured at discharge expected average of 4 weeks into protocol

• Change in deep cervical flexor endurance test

  Initial examination, after 2 visit (expected average day 3) and at discharge ( expected average 4 weeks),

Study Arms (2)

Cervical and thoracic mobilization

EXPERIMENTAL

Cervical and thoracic mobilization: described as a repetitive low-velocity oscillatory movement applied to a joint segment. It is graded 1-4 based on the size of the amplitude and where in range it is being applied. The mobilization technique chosen will be based on the examination and clinical reasoning process of the therapist. The cervical and thoracic mobilization will be applied to the most provocative level.

Other: Cervical and thoracic mobilization

Cervical and thoracic manipulation

EXPERIMENTAL

Cervical and thoracic manipulation: is defined as high-velocity low-amplitude thrust at end range of a particular spinal segment. The therapist performs this technique by taking up all available slack at a particular segment and applying a high-velocity thrust through the end-range restriction. The manipulation technique will be chosen based on the examination and clinical reasoning process of the therapist.

Other: cervical and thoracic manipulation

Interventions

Cervical and thoracic mobilization OTHER

Described in arm description

Cervical and thoracic mobilization

cervical and thoracic manipulation OTHER

described in arm description

Cervical and thoracic manipulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects aged 18-70 years old with a chief complaint of reproducible neck pain and an NDI score of 10 or greater.

Sponsors & Collaborators

• Youngstown State University: lead
• Franklin Pierce University: collaborator

Study Sites (2)

Rehabilitex Inc.

Solon, Ohio, 44139, United States

Location

Pain Relief and Physical Therapy

Havertown, Pennsylvania, 19083, United States

Location

Related Publications (5)

• Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.

  PMID: 21979312 RESULT

• Cross KM, Kuenze C, Grindstaff TL, Hertel J. Thoracic spine thrust manipulation improves pain, range of motion, and self-reported function in patients with mechanical neck pain: a systematic review. J Orthop Sports Phys Ther. 2011 Sep;41(9):633-42. doi: 10.2519/jospt.2011.3670. Epub 2011 Aug 31.

  PMID: 21885904 RESULT

• Lau HM, Wing Chiu TT, Lam TH. The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain - a randomized controlled trial. Man Ther. 2011 Apr;16(2):141-7. doi: 10.1016/j.math.2010.08.003. Epub 2010 Sep 1.

  PMID: 20813577 RESULT

• Leaver AM, Refshauge KM, Maher CG, Latimer J, Herbert RD, Jull G, McAuley JH. Efficacy of manipulation for non-specific neck pain of recent onset: design of a randomised controlled trial. BMC Musculoskelet Disord. 2007 Feb 26;8:18. doi: 10.1186/1471-2474-8-18.

  PMID: 17324291 RESULT

• Miller J, Gross A, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manual therapy and exercise for neck pain: A systematic review. Man Ther. 2010 Jun 1. doi: 10.1016/j.math.2010.02.007. Online ahead of print.

  PMID: 20627797 RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David W. Griswold, DPT

  Youngstown State University

  PRINCIPAL INVESTIGATOR

• David W Griswold, DPT

  Youngstown State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kenneth Learman

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: January 15, 2014
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

US (2)