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Thrust Manipulation vs. Non-thrust Mobilizations for Mechanical Neck Pain

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ClinicalTrials.gov Identifier: NCT02619500
Recruitment Status : Unknown
Verified February 2016 by David W. Griswold, Youngstown State University.
Recruitment status was:  Recruiting
First Posted : December 2, 2015
Last Update Posted : February 12, 2016
Sponsor:
Collaborator:
Nova Southeastern University
Information provided by (Responsible Party):
David W. Griswold, Youngstown State University

Brief Summary:
The purpose of this clinical trial is to compare the use of thrust manipulation to non-thrust mobilizations for mechanical neck pain when they are applied to both the cervical and thoracic spine. Both of these techniques have been compared in previous trials but a pragmatic approach will be employed as well as controlling for clinical equipoise.

Condition or disease Intervention/treatment Phase
Neck Pain Other: Home Exercise Program Other: Patient advice, encouragement, and education Other: Thrust Manipulation Other: Non-thrust Mobilizations Not Applicable

Detailed Description:
A total sample size of 136 subjects with mechanical neck pain will be recruited to participant in this trial from multiple clinic and university sites around the country. Each subject will be evaluated by a licensed physical therapist that specializes in orthopedic manual therapy (OMT). Each treating therapist will be blinded be the data collection and each data collection therapist will be blinded to the treatment allocation. Subjects data will be collected at the initial visit, second visit, and at discharge. The maximum number of weeks that a subject may be enrolled is 8 weeks (2 months). At that point, they are discharged from the study. The treating therapist will allocate the subject through the already completed randomization procedures. Once the subject is randomized, the treating therapist will perform the OMT based on their clinical reasoning and in a manner they feel would benefit the patient the most. In addition to the OMT, each subject will receive a home exercise program, advice, encouragement, and education. A number of outcome variables will be collected regarded pain and disability as well as one physical performance measure.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pragmatically Applied Cervical and Thoracic Non-thrust Mobilizations Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial
Study Start Date : February 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thrust Manipulation
Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.
Other: Home Exercise Program
A standardized home exercise program will be given to subjects that will include active range of motion of the cervical and thoracic spine and deep cervical flexion endurance exercises.

Other: Patient advice, encouragement, and education
Therapists will provide each subject with advice and education pertaining to their condition as well as encouragement towards reducing pain and disability.

Other: Thrust Manipulation
High velocity low amplitude (HVLA) thrust performed at or near the end range of a targeted segment in both the cervical and thoracic spine

Active Comparator: Non-thrust Mobilizations
Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines
Other: Home Exercise Program
A standardized home exercise program will be given to subjects that will include active range of motion of the cervical and thoracic spine and deep cervical flexion endurance exercises.

Other: Patient advice, encouragement, and education
Therapists will provide each subject with advice and education pertaining to their condition as well as encouragement towards reducing pain and disability.

Other: Non-thrust Mobilizations
Repetitive and rhythmic accessory passive movements applied with either small or large amplitude at a targeted segment to both the cervical and thoracic spine




Primary Outcome Measures :
  1. Change from baseline on the Neck Disability Index (NDI) [ Time Frame: 3 days and 8 weeks ]
    The NDI is a self-report measure of perceived disability and it is comprised of ten questions using an ordinal scale from 0 to 5 for a maximum of 50 points. The score is doubled to achieve a % score. The higher an individual scores on the NDI, the greater their perceived level of disability.


Secondary Outcome Measures :
  1. Change from baseline on The Patient Specific Functional Scale (PSFS) [ Time Frame: 3 days and 8 weeks ]
    The PSFS is a patient identified self-report questionnaire that measures general activity limitations. The scale ranges from 0 (unable to perform) to 10 (able to perform the activity at the level prior to injury). The patient reports three activities that are limited due to the current injury and an average rating for all three activities is calculated.

  2. Change from baseline on The Numerical Pain Rating Scale (NPRS) [ Time Frame: 3 days and 8 weeks ]
    The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Two separate pain ratings will be collected (current and average over a 24 hour period) experienced over 24 hours and then averaged for a composite score.

  3. Change from baseline on The Global Rating Of Change Scale (GROC) [ Time Frame: 3 days and 8 weeks ]
    The GROC is a 15-point scale used to quantify a patient's improvement with treatment or to record the clinical course of a condition over time. Patients are asked to describe their overall condition since the start of treatment until the present time with options ranging from -7 ("a very great deal worse") to +7 ("a very great deal better") and 0 being described as "about the same."

  4. Change from baseline on the Deep Cervical Flexion Endurance (DCF) [ Time Frame: 3 days and 8 weeks ]
    Patients are positioned in supine and will be instructed to maximally tuck his/her chin isometrically. Patients will then be instructed to lift their head 2.5 cm off the plinth and to maintain upper cervical flexion simultaneously for as long as they were able. A skin fold along the antero-lateral neck will be monitored and the investigator's hand will remain under the occiput of the patient for tactile cueing. The timing of the position began once the patient is in the correct position and stopped if; the patient's head drops into the fingers of the clinician, is elevated greater than one inch, the patient loses the skin fold on the antero-lateral neck, or the patient is unable to continue.


Other Outcome Measures:
  1. Questionnaire using a scale that rates each clinicians own Clinical Equipoise [ Time Frame: baseline only ]

    Therapist equipoise will be measured globally regarding both of the orthopedic manual therapy techniques on a single scale that ranges form 0 to +2 (only a single measure. Each treating therapist will make a global opinion regarding the efficacy of non-thrust mobilization compared to thrust manipulation. An ordinal scale will be used with a score of 0 meaning that the clinician does not believe that either of the competing treatments are more beneficial than the other. The scale then ranges from +1 and +2 for both mobilizations and manipulations. The rater circles if one of the numbers depending on which of the treatments they feel are clinically more effective. See below.

    Mobilization is better Neither Manipulation is better

    +2 - 1 - 0 - +1 - +2




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chief complaint of neck pain. (Non-specific neck pain with a primary location between the superior nuchal line and the first thoracic spinous process)
  • Age >18
  • A minimum Neck Disability Index (NDI) score ≥ 20%

Exclusion Criteria:

  • Contraindications to OMT including; malignancy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term corticosteroid use.
  • Nerve root compression diagnosed as having at least 2 of the following:

    • Upper extremity muscle weakness within a specific cervical/thoracic myotome
    • Diminished deep tendon reflexes of the biceps brachii, brachioradialis, or triceps muscle.
    • Diminished sensation to light touch or pinprick in a specific upper extremity dermatome.
  • History of neck or thoracic spine surgery
  • Neck pain of <2 on the NPRS
  • Currently receiving other forms of conservative care and unwilling to stop for the duration of their participation in the study.
  • Any pending litigation related to their neck pain
  • Therapist is unable to elicit the chief complaint with passive accessory intervertebral movements (PAIVM).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619500


Contacts
Contact: David W Griswold, DPT 330-941-2419 dwgriswold@ysu.edu
Contact: Ken L Learman, PhD 330-947125 klearman@ysu.edu

Locations
United States, Ohio
Youngstown state university Recruiting
Youngstown, Ohio, United States, 44406
Contact: David W Griswold, DPT    330-701-5353    Dwgriswold@ysu.edu   
Contact: Ken L Learman, PhD    3302617376    Klearman@ysu.edu   
Sponsors and Collaborators
Youngstown State University
Nova Southeastern University
Investigators
Study Chair: Josh Cleland, PhD Nova Southeastern University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David W. Griswold, Assistant Professor of Physical Therapy, Youngstown State University
ClinicalTrials.gov Identifier: NCT02619500     History of Changes
Other Study ID Numbers: 033-16
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

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