Comparison of Outcomes Between Early Physical Therapy Intervention and Usual Care Following Anterior Cervical Fusion Surgery

NCT01519115 | Completed DMC

• 1 other identifier: 16841
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to be effective in reducing neck pain, restoring cervical spinal function and mobility in many types of cervical spine dysfunction. However, the training of stabilizers has not been studied in individuals undergoing cervical spinal surgery, even though these individuals often have problems with residual pain and weakness after the surgery. Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes between an early PT intervention and usual care in patients who have undergone anterior cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved with early PT intervention. Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3) research design. The patients following ACF surgery will be randomly assigned in one of the two treatment groups: usual care and early intervention. Three outcome measures will be collected pre-operative for baseline, and then at 6-week and 12-week post-operative follow-up visits, including: (1) deep cervical flexor (DCF) strength as determined by the cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability associated neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3) neck pain level using the numeric pain rating scale (NPRS). In addition, at 6 and 12 weeks, the global rate of change (GROC) scale will be obtained to determine the patient's perception of overall improvement as a result of surgery. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the usual care group will receive only one visit of PT for post-operative instruction. The early intervention group will receive verbal and written instructions for posture and training cervical spine stabilizers in addition to the usual care. The early intervention group also will be asked to perform these exercises at home and keep a log of the exercise. Data Analysis: Two 2x3 MANOVAs with repeated measures will be used to examine the differences in the CCF strength and the NDI scores between groups and at the three different time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the differences in the NPRS and GROC data over time and between groups.

Conditions

Cervical Spine Degenerative Disc Disease; Fusion of Spine, Cervical Region

Keywords

deep cervical flexors; spine stabilization; posture; function; neck pain

Outcome Measures

Primary Outcomes (1)

• Change in cranio-cervical flexor strength from before surgery to 6 and 12 weeks post operative

  test described in protocol information

  during preo-perative medical exam 1-2 weeks before surgery, and 6 and 12 weeks post

Secondary Outcomes (1)

• Change in Neck Disability Index from pre-operative condition to 6 and 12 weeks post operative

  during pre-operative medical exam 1-2 weeks before surgery and 6 and 12 weeks post

Study Arms (2)

Usual care

ACTIVE COMPARATOR

usual care of one physical therapy visit in hospital after ACF surgery

Other: usual care

Early physical therapy intervention

EXPERIMENTAL

early physical therapy program instructed and followed at home for 6 weeks

Other: early physical therapy intervention

Interventions

early physical therapy intervention OTHER

instruction in home care program to be followed for first six weeks after ACF surgery

Also known as: cervical spine stabilization, posture training, perioperative spine care

Early physical therapy intervention

usual care OTHER

one physical therapy visit in hospital following ACF surgery

Also known as: post operative spine precautions, perioperative spine care

Usual care

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the age of 30 to 70 years
• Individuals who have consulted one of the five participating spine surgeons and are scheduled for ACF surgery at Texas Spine and Joint Hospital
• Surgical candidates classified as Task Force category III, with neurologic deficit without major structural pathology, or IV, with major structural pathology -

You may not qualify if:

• Musculoskeletal or systemic disorders with functional impairments that will limit tolerance of testing.
• Pain greater than 8/10 on the NPRS that often indicates severe pathology and therefore limits testing tolerance.
• Prior cervical spine surgeries.
• More than two level cervical spine surgery planned. -

Sponsors & Collaborators

• Texas Woman's University: lead
• Texas Society of Allied Health Professions: collaborator
• Texas Spine and Joint Hospital: collaborator

Study Sites (1)

Texas Spine and Joint Hospital

Tyler, Texas, 75701, United States

Location

Related Publications (7)

• Abbott AD, Tyni-Lenne R, Hedlund R. Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion: a randomized controlled trial. Spine (Phila Pa 1976). 2010 Apr 15;35(8):848-57. doi: 10.1097/BRS.0b013e3181d1049f.

  PMID: 20354468 BACKGROUND

• Peolsson A, Kjellman G. Neck muscle endurance in nonspecific patients with neck pain and in patients after anterior cervical decompression and fusion. J Manipulative Physiol Ther. 2007 Jun;30(5):343-50. doi: 10.1016/j.jmpt.2007.04.008.

  PMID: 17574951 BACKGROUND

• Ylinen JJ, Savolainen S, Airaksinen O, Kautiainen H, Salo P, Hakkinen A. Decreased strength and mobility in patients after anterior cervical diskectomy compared with healthy subjects. Arch Phys Med Rehabil. 2003 Jul;84(7):1043-7. doi: 10.1016/s0003-9993(03)00039-x.

  PMID: 12881832 BACKGROUND

• O'Leary S, Falla D, Elliott JM, Jull G. Muscle dysfunction in cervical spine pain: implications for assessment and management. J Orthop Sports Phys Ther. 2009 May;39(5):324-33. doi: 10.2519/jospt.2009.2872.

  PMID: 19411767 BACKGROUND

• Chiu TT, Law EY, Chiu TH. Performance of the craniocervical flexion test in subjects with and without chronic neck pain. J Orthop Sports Phys Ther. 2005 Sep;35(9):567-71. doi: 10.2519/jospt.2005.35.9.567.

  PMID: 16268243 BACKGROUND

• Johansson AC, Linton SJ, Bergkvist L, Nilsson O, Cornefjord M. Clinic-based training in comparison to home-based training after first-time lumbar disc surgery: a randomised controlled trial. Eur Spine J. 2009 Mar;18(3):398-409. doi: 10.1007/s00586-008-0826-3. Epub 2008 Nov 20.

  PMID: 19020904 BACKGROUND

• McFarland C, Wang-Price S, Gordon CR, Danielson GO, Crutchfield JS, Medley A, Roddey T. A Comparison of Clinical Outcomes between Early Cervical Spine Stabilizer Training and Usual Care in Individuals following Anterior Cervical Discectomy and Fusion. Rehabil Res Pract. 2020 Apr 24;2020:5946152. doi: 10.1155/2020/5946152. eCollection 2020.

  PMID: 32373366 DERIVED

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Sharon Wang, PT, PhD

  Texas Woman's University

  STUDY CHAIR

• Carol McFarland, PT, MS

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carol McFarland PT, MS, doctoral student

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 26, 2012
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

US (1)