Cervical and Upper Thoracic Mobilization and Manipulation for Mechanical Neck Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Youngstown State University
Sponsor:
Collaborator:
Franklin Pierce University
Information provided by (Responsible Party):
Kenneth Learman, Youngstown State University
ClinicalTrials.gov Identifier:
NCT02036905
First received: July 15, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Neck Pain
Other: Cervical and thoracic mobilization
Other: cervical and thoracic manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Early Use of Cervical/Upper Thoracic Mobilization and Manipulation for Individuals With Mechanical Neck Pain.

Resource links provided by NLM:


Further study details as provided by Youngstown State University:

Primary Outcome Measures:
  • Change in Neck Disability Index (NDI) [ Time Frame: Initial evaluation, 2nd visit expected average day 3, and discharge expected average 4 weeks. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • change in numeric pain rating scale (NPRS) [ Time Frame: initial evaluation, 2nd visit expected average day 3, discharge expected average 4 weeks ] [ Designated as safety issue: No ]
    The NPRS is used to determine the patient's pain level. The patient is asked to rate their level of pain on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain."

  • Change in patient specific functional scale (PSFS) [ Time Frame: Initial evaluation, 2nd visit expected average day 3, and at discharge expected average 4 weeks. ] [ Designated as safety issue: No ]
    The PSFS is a three item questionnaire where the patient is asked to list 3 items they are having difficulty with and rate them on a 0-10 scale with 0 being unable to perform and 10 being able to perform with no limitation.

  • Change in the global rating of change [ Time Frame: after visit 2 (expected average day 3) and again at discharge expected average 4 weeks. ] [ Designated as safety issue: No ]
    The global rating of change is a 15-point scale where 0 is no change in condition, -7 is a very great deal worse and +7 is a very great deal better. The patient is asked to rate their overall current current condition compared with when they first started care.

  • Percent recovery [ Time Frame: Measured at discharge expected average of 4 weeks into protocol ] [ Designated as safety issue: No ]
    The patient is asked to rate their overall improvement on a scale of 0% (no better) to 100% completely better

  • Change in deep cervical flexor endurance test [ Time Frame: Initial examination, after 2 visit (expected average day 3) and at discharge ( expected average 4 weeks), ] [ Designated as safety issue: No ]
    The patient lies in supine and maximally tucks chin to activate the deep cervical flexors. The patient then is asked to lift their head 0.5-1.0 inches off the table and maintain the chin tuck and hold for as long as possible. The investigator times the hold and records when the position cannot be maintained any longer.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervical and thoracic mobilization
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
Described in arm description
Experimental: Cervical and thoracic manipulation
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
described in arm description

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects are excluded if they have had recent whiplash or significant trauma, demonstrate red flag items such as malignancy, radiculopathy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term steroid use, or history of neck surgery. Additional exclusion criteria including neck pain of <2 on the NPRS, PSFS ≤ 8, no prior treatment within 6 weeks time, upper limb symptoms, or any pending litigation. Finally, if a therapist determines the patient has a neck condition that is highly irritable where the manipulation is not appropriate, they will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036905

Contacts
Contact: David W Griswold, DPT 3309412419 dwgriswold@ysu.edu
Contact: Ken Learman, PhD 3309413000 klearman@ysu.edu

Locations
United States, Ohio
Rehabilitex Inc. Recruiting
Solon, Ohio, United States, 44139
Contact: Frank L Gargao, DPT    440-498-9723    garganof@me.com   
Sub-Investigator: Nick Sanders, DPT         
United States, Pennsylvania
Pain Relief and Physical Therapy Recruiting
Havertown, Pennsylvania, United States, 19083
Contact: Bryan O'Halloran, PT    610-789-9887    bryano@painrelief-pt.com   
Sponsors and Collaborators
Youngstown State University
Franklin Pierce University
Investigators
Principal Investigator: David W. Griswold, DPT Youngstown State University
Principal Investigator: David W Griswold, DPT Youngstown State University
  More Information

Publications:
Responsible Party: Kenneth Learman, Dr. Kenneth Learman, Youngstown State University
ClinicalTrials.gov Identifier: NCT02036905     History of Changes
Other Study ID Numbers: 181-13
Study First Received: July 15, 2013
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Youngstown State University:
neck pain, orthopedic manual therapy

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014