The Effectiveness of Anti-Gravity Treadmill Training

Lumbar Degenerative Disc Disease Clinical Trial

Official title:

The Effectiveness of Anti-Gravity Treadmill Training in Patients After Lumbar Microdiscectomy and Fusion Surgeries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01689922
• Other study ID #: JPNI-2
• Status: Terminated
• Phase: N/A
• First received: June 12, 2012
• Last updated: February 28, 2017
• Start date: June 2012
• Est. completion date: August 2016

Study information

• Verified date: February 2017
• Source: Justin Parker Neurological Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to compare the effectiveness of standard for our practice postoperative physical therapy (PT) program to a PT program that incorporates lower body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and fusion surgeries.

Description:

A prospective, randomized, parallel group controlled clinical study is proposed. The patients will be divided into the two study groups according to the surgical procedure:

1. patients undergoing one-level microdiscectomy for lumbar herniated disc

2. patients undergoing one-level lumbar fusion for degenerative disc disease without notable spinal stenosis.

Each group will consist of 60 patients (see sample size calculations below) who will be randomized into the two equal groups to undergo:

1. Standard postoperative rehabilitation program

2. Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults between 18 and 65 years old

• Willing and able to comply with protocol and PT requirements

• Patients with primarily radicular and back pain due to degenerative disc disease requiring one-level discectomy for herniated disc or lumbar fusion between L2 and S1

• Willing and able to sign a study specific informed consent

Exclusion Criteria:

• Require more than one-level surgery

• No previous lumbar surgery

• Any ongoing health condition that would make it difficult to adhere to postoperative PT requirements

• Peri-operative or post-operative complications (infection, pneumonia, nerve injury, dural tear, etc.) that would constraint or delay the ability to participate in postoperative PT

• BMI greater than 40

• Active local or systemic infection

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

Intervention

Other:
• AlterG
All patients will begin an early postoperative rehabilitation program and standard PT no later than 4 weeks following surgery and continue for at least 6 weeks. The duration of standard PT program could be extended depending on the patient needs. The patients randomized to undergo (LBPP) treadmill training will have an additional 7-week 3 times a week training on the antigravity

Locations

Country	Name	City	State
United States	Boulder Neurosurgical Associates	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Justin Parker Neurological Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Questionnaire	10 points or 20% improvement on Oswestry Disability Questionnaire	24 months
Secondary	Patient Global Outcome Ratings and Health Quality Improvement		24 months