NCT02619500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

November 24, 2015

Last Update Submit

February 11, 2016

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change from baseline on The Patient Specific Functional Scale (PSFS)

    3 days and 8 weeks

  • Change from baseline on The Numerical Pain Rating Scale (NPRS)

    3 days and 8 weeks

  • Change from baseline on The Global Rating Of Change Scale (GROC)

    3 days and 8 weeks

  • Change from baseline on the Deep Cervical Flexion Endurance (DCF)

    3 days and 8 weeks

Other Outcomes (1)

  • Questionnaire using a scale that rates each clinicians own Clinical Equipoise

    baseline only

Study Arms (2)

Thrust Manipulation

EXPERIMENTAL

Subjects in this arm will receive spinal thrust manipulation to both the cervical and thoracic spines.

Other: Home Exercise ProgramOther: Patient advice, encouragement, and educationOther: Thrust Manipulation

Non-thrust Mobilizations

ACTIVE COMPARATOR

Subjects in this arm will receive spinal non-thrust mobilizations to both the cervical and thoracic spines

Other: Home Exercise ProgramOther: Patient advice, encouragement, and educationOther: Non-thrust Mobilizations

Interventions

Home Exercise ProgramOTHER

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.

Non-thrust MobilizationsThrust Manipulation
Patient advice, encouragement, and educationOTHER

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

Non-thrust MobilizationsThrust Manipulation
Thrust ManipulationOTHER

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

Thrust Manipulation
Non-thrust MobilizationsOTHER

Repetitive and rhythmic accessory passive movements applied with either small or large amplitude at a targeted segment to both the cervical and thoracic spine

Non-thrust Mobilizations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown state university

Youngstown, Ohio, 44406, United States

RECRUITING

Related Publications (5)

  • 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: 26109828BACKGROUND

  • 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: 25125936BACKGROUND

  • 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: 21979312BACKGROUND

  • 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: 23040656BACKGROUND

  • 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.

    PMID: 29406835DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Josh Cleland, PhD

    Nova Southeastern University

    STUDY CHAIR

Central Study Contacts

David W Griswold, DPT

CONTACT

330-941-2419dwgriswold@ysu.edu

Ken L Learman, PhD

CONTACT

330-947125klearman@ysu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 2, 2015

Study Start

February 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

US(1)