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).


Study is Available At:


Original ID:

033-16


NCT ID:

NCT02619500


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Youngstown State University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

136


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Josh Cleland, PhD
Study Chair
Nova Southeastern University
Primary Contact:David W Griswold, DPT
330-941-2419
dwgriswold@ysu.edu
Backup Contact:Ken L Learman, PhD
330-947125
klearman@ysu.edu

Study Dates

Start Date:February 2016
Completion Date:November 2017
Completion Type:Anticipated
Primary Completion Date:November 2017
Primary Completion Type:Anticipated
Verification Date:February 2016
Last Changed Date:February 11, 2016
First Received Date:November 24, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline on the Deep Cervical Flexion Endurance (DCF)
Time Frame:3 days and 8 weeks
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change from baseline on The Global Rating Of Change Scale (GROC)
Time Frame:3 days and 8 weeks
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change from baseline on The Numerical Pain Rating Scale (NPRS)
Time Frame:3 days and 8 weeks
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change from baseline on The Patient Specific Functional Scale (PSFS)
Time Frame:3 days and 8 weeks
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Change from baseline on the Neck Disability Index (NDI)
Time Frame:3 days and 8 weeks
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Other
Name:Home Exercise Program
Description: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.
Arm Name:Thrust Manipulation
Intervention Type:Other
Name:Patient advice, encouragement, and education
Description:Therapists will provide each subject with advice and education pertaining to their condition as well as encouragement towards reducing pain and disability.
Arm Name:Thrust Manipulation
Intervention Type:Other
Name:Thrust Manipulation
Description:High velocity low amplitude (HVLA) thrust performed at or near the end range of a targeted segment in both the cervical and thoracic spine
Arm Name:Thrust Manipulation
Intervention Type:Other
Name:Non-thrust Mobilizations
Description:Repetitive and rhythmic accessory passive movements applied with either small or large amplitude at a targeted segment to both the cervical and thoracic spine
Arm Name:Non-thrust Mobilizations

Study Arms

Study Arm Type:Active Comparator
Arm Name:Non-thrust Mobilizations
Description:Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines
Study Arm Type:Experimental
Arm Name:Thrust Manipulation
Description:Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Youngstown State University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Nova Southeastern University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:23040656
Reference Type:Reference
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.
PMID:21979312
Reference Type:Reference
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.
PMID:25125936
Reference Type:Reference
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.
PMID:26109828

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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