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

NCT ID: NCT02619500

Last Updated: 2016-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-11-30

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Thrust Manipulation

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

Group Type: EXPERIMENTAL

Home Exercise Program

Intervention Type: OTHER

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.

Patient advice, encouragement, and education

Intervention Type: OTHER

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

Thrust Manipulation

Intervention Type: OTHER

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

Non-thrust Mobilizations

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

Group Type: ACTIVE_COMPARATOR

Home Exercise Program

Intervention Type: OTHER

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.

Patient advice, encouragement, and education

Intervention Type: OTHER

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

Non-thrust Mobilizations

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: collaborator

Youngstown State University

OTHER

Sponsor Role: lead

Responsible Party

David W. Griswold

Assistant Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josh Cleland, PhD

Role: STUDY_CHAIR

Nova Southeastern University

Locations

Youngstown state university

Youngstown, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David W Griswold, DPT

Role: CONTACT

dwgriswold@ysu.edu

330-941-2419

Ken L Learman, PhD

Role: CONTACT

klearman@ysu.edu

330-947125

Facility Contacts

David W Griswold, DPT

Role: primary

Dwgriswold@ysu.edu

330-701-5353

Ken L Learman, PhD

Role: backup

Klearman@ysu.edu

3302617376

References

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.

Reference Type: BACKGROUND

PMID: 26109828 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25125936 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21979312 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23040656 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29406835 (View on PubMed)

Other Identifiers

033-16

Identifier Type: -

Identifier Source: org_study_id