Clinical trial NCT02619500: Thrust Manipulation vs. Non-thrust Mobilizations for Mechanical Neck Pain
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: Youngstown State University
Sponsor class: OTHER
Collaborators: name: Nova Southeastern University
First posted: 2015-12-02
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Change from baseline on the Neck Disability Index (NDI)
timeFrame: 3 days and 8 weeks
Secondary outcomes:
measure: Change from baseline on The Patient Specific Functional Scale (PSFS)
timeFrame: 3 days and 8 weeks
measure: Change from baseline on The Numerical Pain Rating Scale (NPRS)
timeFrame: 3 days and 8 weeks
measure: Change from baseline on The Global Rating Of Change Scale (GROC)
timeFrame: 3 days and 8 weeks
measure: Change from baseline on the Deep Cervical Flexion Endurance (DCF)
timeFrame: 3 days and 8 weeks
Other outcomes:
measure: Questionnaire using a scale that rates each clinicians own Clinical Equipoise
timeFrame: baseline only
Locations:
city: Youngstown
country: United States
facility: Youngstown state university
state: Ohio
Study officials:
affiliation: Nova Southeastern University
name: Josh Cleland, PhD
role: STUDY_CHAIR
References:
citation: Griswold D, Learman K, O'Halloran B, Cleland J. A preliminary study comparing the use of cervical/upper thoracic mobilization and manipulation for individuals with mechanical neck pain. J Man Manip Ther. 2015 May;23(2):75-83. doi: 10.1179/2042618614Y.0000000095.
citation: Young JL, Walker D, Snyder S, Daly K. Thoracic manipulation versus mobilization in patients with mechanical neck pain: a systematic review. J Man Manip Ther. 2014 Aug;22(3):141-53. doi: 10.1179/2042618613Y.0000000043.
citation: 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.
citation: Cook C, Learman K, Showalter C, Kabbaz V, O'Halloran B. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013 Jun;18(3):191-8. doi: 10.1016/j.math.2012.08.005. Epub 2012 Oct 2.
citation: Griswold D, Learman K, Kolber MJ, O'Halloran B, Cleland JA. Pragmatically Applied Cervical and Thoracic Nonthrust Manipulation Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial. J Orthop Sports Phys Ther. 2018 Mar;48(3):137-145. doi: 10.2519/jospt.2018.7738. Epub 2018 Feb 6.