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

A Pragmatically Applied Cervical and Thoracic Non-thrust Mobilizations Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial

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 Overview

• Status: Unknown
• Conditions: Neck Pain
• Intervention / Treatment: Other: Home Exercise Program; Other: Patient advice, encouragement, and education; Other: Thrust Manipulation; Other: Non-thrust Mobilizations

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
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44406
      • Recruiting
      • Youngstown State University
      • Contact: David W Griswold, DPT; Phone Number: 330-701-5353; Email: Dwgriswold@ysu.edu
      • Contact: Ken L Learman, PhD; Phone Number: 3302617376; Email: Klearman@ysu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on the Neck Disability Index (NDI)	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.	3 days and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on The Patient Specific Functional Scale (PSFS)	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.	3 days and 8 weeks
Change from baseline on The Numerical Pain Rating Scale (NPRS)	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 days and 8 weeks
Change from baseline on The Global Rating Of Change Scale (GROC)	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."	3 days and 8 weeks
Change from baseline on the Deep Cervical Flexion Endurance (DCF)	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.	3 days and 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire using a scale that rates each clinicians own Clinical Equipoise	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	baseline only

Collaborators and Investigators

• Sponsor: Youngstown State University
• Collaborators: Nova Southeastern University
• Investigators: Study Chair: Josh Cleland, PhD, Nova Southeastern University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 24, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 033-16