Improving recovery after cervical spine surgery with early physical therapy

Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion

This study is testing if starting physical therapy sooner after neck surgery helps people recover better than waiting a few months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (other)
• Locations: 4 sites (Honolulu, Hawaii and 3 other locations)
• Trial ID: NCT06202443 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of early postoperative physical therapy (PT) compared to delayed PT on recovery outcomes after anterior cervical discectomy and fusion (ACDF) surgery for degenerative conditions. Participants will be randomly assigned to receive PT within two weeks post-surgery or after three months. The study aims to measure improvements in disability, pain, physical function, and return to work, with a total of 76 participants expected to be enrolled and followed for 12 months. The trial will assess various outcomes, including handgrip strength and cervical range of motion, to determine the effectiveness of early intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 undergoing ACDF surgery for cervical degenerative conditions.

Not a fit: Patients with a history of trauma, severe psychiatric disorders, or those unable to attend follow-up visits may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery outcomes and reduced disability for patients undergoing ACDF surgery.

How similar studies have performed: Other studies have shown promising results with early physical therapy interventions in surgical recovery, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure;
* English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
* Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)

Exclusion Criteria:

* Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
* Undergoing cervical corpectomy;
* Prior history of cervical spine surgery in last 5 years;
* Diagnosis or presence of osteoporosis;
* Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder;
* Documented history of alcohol and/or drug abuse;
* Currently involved in litigation due to injury;
* Currently undergoing treatment for cancer;
* Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and
* Unable to provide a stable telephone or physical address

Where this trial is running

Honolulu, Hawaii and 3 other locations

• Tripler Army Medical Center — Honolulu, Hawaii, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
• Booke Army Medical Center — Fort Sam Houston, Texas, United States (RECRUITING)
• Madigan Army Medical Center — Tacoma, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Kristin Archer, PhD — Vanderbilt University Medical Center
• Study coordinator: Amanda Priest

Conditions: Cervical Spine Degeneration, ACDF Surgery