Bio-mechanical Reasoning and Lateral Specificity of Upper Cervical Joint Mobilization

NCT04054869 | Unknown

• 1 other identifier: IRB 19-089
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Participants with limited neck rotation are recruited to determine if manual therapy (joint stretching) techniques applied in a bio-mechanically correct sequence will improve neck motion, function and pain better than if the manual therapy is applied in the opposite direction. Each participant will receive both the correct and the incorrect applications in randomized order with each treatment separated by 2-3 days. Improvement in neck motion, function and pain will be assessed after each session.

Conditions

Neck Pain

Keywords

neck stiffness; manual therapy; joint mobilization

Outcome Measures

Primary Outcomes (1)

• intra-visit change in cervical active range of motion rotation

  measured by standard goniometry

  day 1: pre and post treatment change, day 3: pre and post treatment change

Secondary Outcomes (3)

• intra-visit change in cervical pain at rest

  day 1: pre and post treatment change, day 3: pre and post treatment change

• inter-visit change in neck disability/function

  change between day 1 and day 3, change between day 3 and day 5

• intra-visit change in cervical pain during most restricted active rotation

  day 1: pre and post treatment change, day 3: pre and post treatment change

Study Arms (2)

Bio-mechanically correct manual therapy (received first) arm

EXPERIMENTAL

Participants will be randomized to receive manual therapy directed at the cervical spine atlanto-axial joints in the bio-mechanically correct direction followed by instruction in a home program to maintain this motion. Outcome measures will be assessed. Participants will return in 2-3 days and receive the opposite treatment and home program followed by outcomes assessment. Participants will return again in 2-3 days, outcomes will be assessed and the study will conclude. Participants will then be given the option to continue in formalized physical therapy if desired.

Other: Bio-mechanically correct manual therapy at the cervical atlanto-axial joints; Other: Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints

Bio-mechanically incorrect manual therapy (received first) arm

EXPERIMENTAL

Participants will be randomized to receive manual therapy directed at the cervical spine atlanto-axial joints in the bio-mechanically incorrect direction followed by instruction in a home program to maintain this motion. Outcome measures will be assessed. Participants will return in 2-3 days and receive the opposite treatment and home program followed by outcomes assessment. Participants will return again in 2-3 days, outcomes will be assessed and the study will conclude. Participants will then be given the option to continue in formalized physical therapy if desired.

Other: Bio-mechanically correct manual therapy at the cervical atlanto-axial joints; Other: Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints

Interventions

Bio-mechanically correct manual therapy at the cervical atlanto-axial joints OTHER

Participant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments congruently to the direction of rotational loss.

Also known as: joint mobilization

Bio-mechanically correct manual therapy (received first) arm; Bio-mechanically incorrect manual therapy (received first) arm

Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints OTHER

Participant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments in-congruently to the direction of rotational loss.

Also known as: joint mobilization

Bio-mechanically correct manual therapy (received first) arm; Bio-mechanically incorrect manual therapy (received first) arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males or females between 18 and 80 years of age
• percent or greater asymmetry of active cervical range of motion rotation limited by pain and/or stiffness

You may not qualify if:

• cervical surgeries or injections in the past one year
• current manual or exercise treatment by another provider for neck pain
• cervical manipulation/mobilization/trauma in past 3 months
• cervical radicular or referred pain distal to the acromion
• upper extremity neurologic myotome weakness or constant dermatomal numbness
• pending litigation
• signs of cervical myelopathy or vertebrobasilar artery insufficiency
• use of prescribed anticoagulants or documented blood clotting disorder
• alar or transverse ligament instability

Sponsors & Collaborators

• Andrews University: lead

Study Sites (1)

Indiana University Health - West Hospital

Avon, Indiana, 46123, United States

RECRUITING

Related Publications (13)

• Bishop MD, Mintken PE, Bialosky JE, Cleland JA. Patient expectations of benefit from interventions for neck pain and resulting influence on outcomes. J Orthop Sports Phys Ther. 2013;43(7):457-65. doi: 10.2519/jospt.2013.4492. Epub 2013 Mar 18.

  PMID: 23508341 BACKGROUND

• Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.

  PMID: 22851876 BACKGROUND

• Slaven EJ, Goode AP, Coronado RA, Poole C, Hegedus EJ. The relative effectiveness of segment specific level and non-specific level spinal joint mobilization on pain and range of motion: results of a systematic review and meta-analysis. J Man Manip Ther. 2013 Feb;21(1):7-17. doi: 10.1179/2042618612Y.0000000016.

  PMID: 24421608 BACKGROUND

• Celenay ST, Akbayrak T, Kaya DO. A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Feb;46(2):44-55. doi: 10.2519/jospt.2016.5979. Epub 2016 Jan 11.

  PMID: 26755405 BACKGROUND

• van der Velde G, Yu H, Paulden M, Cote P, Varatharajan S, Shearer HM, Wong JJ, Randhawa K, Southerst D, Mior S, Sutton D, Jacobs C, Taylor-Vaisey A. Which interventions are cost-effective for the management of whiplash-associated and neck pain-associated disorders? A systematic review of the health economic literature by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Spine J. 2016 Dec;16(12):1582-1597. doi: 10.1016/j.spinee.2015.08.025. Epub 2015 Nov 26.

  PMID: 26631759 BACKGROUND

• Schmid A, Brunner F, Wright A, Bachmann LM. Paradigm shift in manual therapy? Evidence for a central nervous system component in the response to passive cervical joint mobilisation. Man Ther. 2008 Oct;13(5):387-96. doi: 10.1016/j.math.2007.12.007. Epub 2008 Mar 3.

  PMID: 18316238 BACKGROUND

• Creighton D, Gruca M, Marsh D, Murphy N. A comparison of two non-thrust mobilization techniques applied to the C7 segment in patients with restricted and painful cervical rotation. J Man Manip Ther. 2014 Nov;22(4):206-12. doi: 10.1179/2042618614Y.0000000077.

  PMID: 25395829 BACKGROUND

• Aquino RL, Caires PM, Furtado FC, Loureiro AV, Ferreira PH, Ferreira ML. Applying Joint Mobilization at Different Cervical Vertebral Levels does not Influence Immediate Pain Reduction in Patients with Chronic Neck Pain: A Randomized Clinical Trial. J Man Manip Ther. 2009;17(2):95-100. doi: 10.1179/106698109790824686.

  PMID: 20046551 BACKGROUND

• Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.

  PMID: 28826164 BACKGROUND

• Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.

  PMID: 26852024 BACKGROUND

• 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 BACKGROUND

• Youdas JW, Carey JR, Garrett TR. Reliability of measurements of cervical spine range of motion--comparison of three methods. Phys Ther. 1991 Feb;71(2):98-104; discussion 105-6. doi: 10.1093/ptj/71.2.98.

  PMID: 1989013 BACKGROUND

• Cleland JA, Childs JD, Whitman JM. Psychometric properties of the Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008 Jan;89(1):69-74. doi: 10.1016/j.apmr.2007.08.126.

  PMID: 18164333 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Williams, MPT

  Andrews University, Indiana University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Williams, MPT

CONTACT

(317)757-9160; mwilliams6@iuhealth.org

Greg Almeter, DScPT

CONTACT

(269)471-6552; almeter@andrews.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants and the outcomes assessor will be masked (blinded) as to the order in which each participant receives the interventions
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: each participant receives both treatments in randomized order

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 13, 2019
• Study Start: November 7, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)