Early vs Delayed Physical Therapy for Cervical Fusion

Recruiting at 2 trial locations

Overseen By Amanda Priest

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Osteoporosis, Severe psychiatric disorder, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 35

76 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Delayed PT, Delayed Physical Therapy, Standard Care, Usual Care, Early PT for cervical fusion?

The research indicates that post-operative physical therapy after cervical spine surgery, like anterior cervical discectomy and fusion, does not show significant benefits in patient-reported outcomes compared to those who did not receive formal physical therapy, suggesting limited effectiveness of the treatment. ^{1 2 3 4 5}

Is post-operative physical therapy after cervical fusion surgery safe?

Orthopaedic physical therapy, including post-operative therapy after cervical spine surgery, is generally considered safe, with no major adverse events reported in studies. However, there is a need for better reporting and standardization of adverse events to ensure comprehensive safety data. ^{1 3 6 7 8}

How does early vs delayed physical therapy differ from other treatments for cervical fusion?

This treatment is unique because it focuses on the timing of physical therapy after cervical fusion surgery, comparing early initiation to delayed therapy. Unlike other treatments that may not consider timing, this approach aims to determine if starting physical therapy sooner can improve recovery outcomes. ^{1 3 4 9 10}

What is the purpose of this trial?

The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery. The main question this clinical trial aims to answer are: * Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants. * Whether improvements in handgrip strength, cervical endurance, and cervical range of motion will be associated with improvements in outcomes. Participants will be randomized to one of two groups (early PT or delayed PT) and outcomes compared across groups.

Research Team

Kristin R Archer, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for individuals who have undergone ACDF surgery to address cervical fusion or cervical spondylosis. The study will include those eligible and willing to start physical therapy (PT) either early or later after their operation.

Inclusion Criteria

I had surgery for neck pain using a 1- or 2-level ACDF procedure.

Exclusion Criteria

Documented history of alcohol and/or drug abuse

Currently involved in litigation due to injury

I had cervical spine surgery within the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants complete a preoperative questionnaire prior to surgery and are randomized into early or delayed PT groups

1 week

Early Physical Therapy

Participants receive PT two times a week for 8 weeks, starting approximately 2 weeks after hospital discharge

8 weeks

16 visits (in-person)

Delayed Physical Therapy

Participants receive PT two times a week for 8 weeks, starting approximately 3 months after hospital discharge

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for disability, opioid utilization, pain intensity, physical function, and return to work at 3, 6, and 12 months after hospital discharge

12 months

3 visits (in-person)

Treatment Details

Interventions

• Delayed PT
• Early PT

Trial Overview The study is testing the effectiveness of starting physical therapy soon after ACDF surgery versus waiting for a delayed PT start. Participants are randomly assigned to one of these two approaches, and their recovery outcomes are compared.

Participant Groups

Group I: Early Physical Therapy (PT) Experimental Treatment 1 Intervention

PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 2 weeks after hospital discharge

Group II: Delayed Physical Therapy (PT) Active Control 1 Intervention

PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 3 months after hospital discharge.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

In a study of 3,609 patients who underwent cervical spine surgery, the most common post-operative complications were new onset cervical pain, revision surgeries, and wound infections, with no significant differences in rates based on the timing of post-operative physical therapy initiation (at 2, 8, or 12 weeks).

The incidence of complications such as cervicalgia and infections remained consistent regardless of when physical therapy started, suggesting that the timing of PT may not influence recovery outcomes after cervical spine surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of complications associated with cervical spine surgery and post-operative physical therapy and implications for timing of initiation of post-operative physical therapy: a retrospective database study. Lantz, JM., Roberts, C., Formanek, B., et al.[2023]

A survey of 20 member organizations and 5 interest groups revealed that 77% use pre-manipulative guidelines for cervical spine manipulation, with Australian guidelines being the most commonly adopted internationally.

The study highlighted inconsistencies in informing patients about potential serious adverse events, as only 50% of organizations standardize this practice, indicating a need for improved safety protocols in cervical spine manipulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulative practice in the cervical spine: a survey of IFOMPT member countries. Carlesso, L., Rivett, D.[2023]

In a study of 220 patients who underwent anterior cervical discectomy and fusion (ACDF), post-operative physical therapy (PT) did not show significant benefits in improving patient-reported outcomes (PROMIS scores) compared to those who did not receive PT.

The only notable difference was in physical health scores at three months post-surgery, where patients who did not attend PT had better scores, but overall, both groups showed improvement over time without significant differences at six months and one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Operative Physical Therapy Following Cervical Spine Surgery: Analysis of Patient-Reported Outcomes. Lorentz, NA., Galetta, MS., Zabat, MA., et al.[2023]

Patients with cervical disorders who had symptoms for more than 6 months showed significantly less functional improvement after physical therapy compared to those with symptoms lasting less than 1 month, indicating that symptom acuity affects recovery outcomes.

The study found that age, symptom duration, and the use of mobilization or manipulation techniques were significant factors influencing patient function at discharge, explaining over 35% of the variance in functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of acuity on physical therapy outcomes for patients with cervical disorders. Boissonnault, WG., Badke, MB.[2007]

Patients undergoing anterior cervical discectomy and fusion (ACDF) showed significant improvements in patient-reported outcome measures (PROMs) at both 90 days and 1 year post-surgery, regardless of the duration of the procedure.

Shorter surgical durations were associated with better improvements in neck and arm pain scores and a decreased length of hospital stay, suggesting that quicker surgeries may lead to more favorable short-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Anterior Cervical Discectomy and Fusion Procedure Duration on Patient-Reported Outcome Measures. Karamian, BA., Minetos, PD., Levy, HA., et al.[2022]

Orthopaedic physical therapy is generally considered safe, but there is a lack of high-quality data documenting its safety, particularly regarding cervical manipulation, highlighting the need for more rigorous research on potential harms.

Current research shows poor reporting standards for adverse events in orthopaedic physical therapy, indicating a need for standardized terminology and better documentation practices to ensure informed consent and clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. Carlesso, LC., Macdermid, JC., Santaguida, LP.[2022]

Cervical manipulation and mobilization techniques for neck pain are generally effective but can be associated with rare serious adverse events, as highlighted by a review of studies from 1998 to 2009.

The review found that while 17 out of 76 studies reported no major adverse events, minor adverse events like transient neurological symptoms and increased neck pain were noted, indicating a need for better reporting of adverse events in manual therapy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Carlesso, LC., Gross, AR., Santaguida, PL., et al.[2022]

In a pilot study involving 20 patients treated by Canadian orthopaedic manual physiotherapists, adverse events from cervical manipulation and mobilization were mostly benign and transient, with 95.6% occurring within 0-12 hours and lasting 0-2 days.

The study faced significant challenges in recruitment and data collection, highlighting the need for improved methods in future larger trials, but it confirmed that no serious adverse events were reported during the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining adverse events in patients with neck pain receiving orthopaedic manual physiotherapy: a pilot and feasibility study. Carlesso, LC., Macdermid, JC., Santaguida, PL., et al.[2021]

In a study of 39,371 patients undergoing elective anterior cervical discectomy and fusion (ACDF), 2.0% experienced surgical delays, which were linked to higher rates of post-operative complications and longer hospital stays.

Key risk factors for surgical delay included impaired functional status, higher comorbidity burden, chronic steroid use, and male sex, highlighting the importance of pre-operative assessments in managing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for delay in surgery for patients undergoing elective anterior cervical discectomy and fusion. Renfree, SP., Makovicka, JL., Chung, AS.[2022]

In a study of 40 patients recovering from anterior cervical discectomy and fusion (ACDF) surgery, both early cervical spine stabilizer (ECS) training and usual care (UC) led to significant improvements in pain and disability levels, showing that both approaches are effective during the first 3 months of recovery.

The study also confirmed that the tests for measuring craniocervical flexor strength and endurance are reliable, providing a useful way to assess recovery in patients after ACDF surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Clinical Outcomes between Early Cervical Spine Stabilizer Training and Usual Care in Individuals following Anterior Cervical Discectomy and Fusion. McFarland, C., Wang-Price, S., Gordon, CR., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Incidence of complications associated with cervical spine surgery and post-operative physical therapy and implications for timing of initiation of post-operative physical therapy: a retrospective database study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Manipulative practice in the cervical spine: a survey of IFOMPT member countries. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Post-Operative Physical Therapy Following Cervical Spine Surgery: Analysis of Patient-Reported Outcomes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Influence of acuity on physical therapy outcomes for patients with cervical disorders. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of Anterior Cervical Discectomy and Fusion Procedure Duration on Patient-Reported Outcome Measures. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. [2022]

7. Scotland pubmed.ncbi.nlm.nih.gov

Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Determining adverse events in patients with neck pain receiving orthopaedic manual physiotherapy: a pilot and feasibility study. [2021]

9. China pubmed.ncbi.nlm.nih.gov

Risk factors for delay in surgery for patients undergoing elective anterior cervical discectomy and fusion. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Clinical Outcomes between Early Cervical Spine Stabilizer Training and Usual Care in Individuals following Anterior Cervical Discectomy and Fusion. [2022]