Cervical and Upper Thoracic Mobilization and Manipulation for Mechanical Neck Pain

Neck Pain Clinical Trial

Official title:

Comparing the Early Use of Cervical/Upper Thoracic Mobilization and Manipulation for Individuals With Mechanical Neck Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036905
• Other study ID #: 181-13
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: January 25, 2016
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Youngstown State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this pilot study is to determine the feasibility of a large-scale trial. The primary objective is to determine if manipulation applied to the cervical and thoracic spines is more effective than mobilization applied to the cervical and thoracic spines for the management of patients with mechanical neck pain.

Description:

All potential subjects will be assessed for eligibility prior to signing the informed consent by filling out a demographic questionnaire and through a subjective interview that will include a health history examination performed by a physical therapist that has received additional training in orthopedic manual therapy. A physical therapist (PT) is a highly educated licensed health care professional that has graduated from an accredited university and has passed a national licensure exam. Physical therapists specialize in movement disorders and are well trained in the examination and treatment for primary and secondary medical conditions pertaining to the cardiovascular, neuromuscular, musculoskeletal, and integumentary body systems. Manual therapy interventions for the neck and thoracic spine including manipulations are taught in entry-level physical therapy programs. Continuing education courses are available for physical therapists to get advanced training in manual therapy. This training involves not only improving the skill set of the therapist but also focuses on enhancing the knowledge of the therapist concerning the safety of patients. Each of the treating therapists will have certifications in manual therapy. Screening for inclusion and exclusion criteria will be done by the treating PT by means of assessing subjective outcomes, patient demographic, and through their subjective history examine. Subjects will then be given the informed consent to be read and signed if they agree to participate. Subjects will be permitted to ask any questions relative to any study procedures they do not understand. Two physical therapists at each facility will be used in order to keep the outcome measures blinded. The treating therapist or clinic PT will perform the examination/evaluation and perform all manual therapy treatments during the first 2 visits of care. Pending there are no scheduling conflicts; the treating therapist will continue to provide the treatment. If there is a scheduling conflict, another physical therapist will provide the patient's care until the next available opening on the treating therapist. The recording therapist, or research therapist, will record all the dependent variables and will remain blinded to group allocation. This is the only assignment given to the research therapist. The treating therapist will be blinded to all results of the outcome data except in the case where data is needed for clinical decision making in order to optimize patient outcomes. After informed consent is attained, outcome data will then be collected by the recording physical therapist that is not aware of group allocation. The data collected will include the neck disability index (NDI), patient specific functional score (PSFS), numeric pain rating scale (NPRS), deep cervical flexion test (DCF), cervical range of motion (CROM) using a CROM, therapist equipoise, and patient preference. Following initial data collection, each subject will be randomized via concealed allocation to receive either mobilization or manipulation directed to the cervical and upper thoracic spine for the first two treatment visits. The patient will be treated on day 1 with their randomized treatment technique. The manual technique chosen for treatment by each clinician will be determined by the results of their physical examination. Other interventions included for both groups will include a standardized exercise program and advice, encouragement, and assurance. Immediately following the treatment procedures, data will be collected again and will include the NPRS, global rating of changes (GROC), cervical range of motion, and DCF. The therapist will determine the next appropriate follow-up visit. Data will again be collected at the beginning of the 2nd visit follow-up and will include NPRS, GROC, cervical range of motion, DCF, PSFS, and NDI by the blinded physical therapist. Treatments of cervical and thoracic mobilization or manipulation will occur again based on group allocation established prior. The technique used by the treating clinician will be based on their assessment of the patient and again will follow group allocation. After the 2nd visit (day 3), the treating physical therapist is able to add or remove treatments, as they deem necessary to improve the patient's condition. Orthopedic manual therapy (mobilization or manipulation) may be adjusted based on patient need as well. Subsequent visits and plan of care will continue under the direction of the physical therapist based on the patient's need. Final data collection performed at discharge will include the NDI, PSFS, GROC, and total number of visits, patient satisfaction, therapist equipoise, and total days of care.

Analysis: Baseline characteristics of all subjects will be compared using either a t-test or chi square as appropriate. A two way multivariate analysis of variance (MANOVA) will be used to compare outcomes of NDI, PSFS, and NPRS at baseline, at day 3, and at day 30.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• subjects aged 18-70 years old with a chief complaint of reproducible neck pain and an NDI score of 10 or greater.

Exclusion Criteria:

• Subjects are excluded if they have had recent whiplash or significant trauma, demonstrate red flag items such as malignancy, radiculopathy, myelopathy, fracture, metabolic disease, rheumatoid arthritis, long-term steroid use, or history of neck surgery. Additional exclusion criteria including neck pain of <2 on the NPRS, PSFS = 8, no prior treatment within 6 weeks time, upper limb symptoms, or any pending litigation. Finally, if a therapist determines the patient has a neck condition that is highly irritable where the manipulation is not appropriate, they will be excluded.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Cervical and thoracic mobilization
Described in arm description
• cervical and thoracic manipulation
described in arm description

Locations

Country	Name	City	State
United States	Pain Relief and Physical Therapy	Havertown	Pennsylvania
United States	Rehabilitex Inc.	Solon	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Youngstown State University	Franklin Pierce University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Cross KM, Kuenze C, Grindstaff TL, Hertel J. Thoracic spine thrust manipulation improves pain, range of motion, and self-reported function in patients with mechanical neck pain: a systematic review. J Orthop Sports Phys Ther. 2011 Sep;41(9):633-42. doi: 1 — View 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 Sp — View Citation

Lau HM, Wing Chiu TT, Lam TH. The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain - a randomized controlled trial. Man Ther. 2011 Apr;16(2):141-7. doi: 10.1016/j.math.2010.08.003. Epub 2010 Sep 1. — View Citation

Leaver AM, Refshauge KM, Maher CG, Latimer J, Herbert RD, Jull G, McAuley JH. Efficacy of manipulation for non-specific neck pain of recent onset: design of a randomised controlled trial. BMC Musculoskelet Disord. 2007 Feb 26;8:18. — View Citation

Miller J, Gross A, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Brønfort G, Hoving JL. Manual therapy and exercise for neck pain: A systematic review. Man Ther. 2010 Jun 1. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neck Disability Index (NDI)	The NDI is a reliable and valid outcome tool for patients with neck pain. It is a self-report measurement tool that was specifically constructed to measure the degree of disability for persons with neck pain. There are 10 total items that are ranked from 0-5 giving a total possible number of 50 points. The larger the score, the greater the disability for that individual.	Initial evaluation, 2nd visit expected average day 3, and discharge expected average 4 weeks.	No
Secondary	change in numeric pain rating scale (NPRS)	The NPRS is used to determine the patient's pain level. The patient is asked to rate their level of pain on an 11-point numerical scale 0-10 with 0 being "no pain" and 10 being the "worst possible pain."	initial evaluation, 2nd visit expected average day 3, discharge expected average 4 weeks	No
Secondary	Change in patient specific functional scale (PSFS)	The PSFS is a three item questionnaire where the patient is asked to list 3 items they are having difficulty with and rate them on a 0-10 scale with 0 being unable to perform and 10 being able to perform with no limitation.	Initial evaluation, 2nd visit expected average day 3, and at discharge expected average 4 weeks.	No
Secondary	Change in the global rating of change	The global rating of change is a 15-point scale where 0 is no change in condition, -7 is a very great deal worse and +7 is a very great deal better. The patient is asked to rate their overall current current condition compared with when they first started care.	after visit 2 (expected average day 3) and again at discharge expected average 4 weeks.	No
Secondary	Percent recovery	The patient is asked to rate their overall improvement on a scale of 0% (no better) to 100% completely better	Measured at discharge expected average of 4 weeks into protocol	No
Secondary	Change in deep cervical flexor endurance test	The patient lies in supine and maximally tucks chin to activate the deep cervical flexors. The patient then is asked to lift their head 0.5-1.0 inches off the table and maintain the chin tuck and hold for as long as possible. The investigator times the hold and records when the position cannot be maintained any longer.	Initial examination, after 2 visit (expected average day 3) and at discharge ( expected average 4 weeks),	No