Youngstown, Ohio 44406


Purpose:

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.


Study summary:

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.


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).


NCT ID:

NCT02619500


Primary Contact:

Study Chair
Josh Cleland, PhD
Nova Southeastern University

David W Griswold, DPT
Phone: 330-941-2419
Email: dwgriswold@ysu.edu


Backup Contact:

Email: klearman@ysu.edu
Ken L Learman, PhD
Phone: 330-947125


Location Contact:

Youngstown, Ohio 44406
United States

David W Griswold, DPT
Phone: 330-701-5353
Email: Dwgriswold@ysu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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