Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04829448 |
| Other study ID # |
Protein and Exercise Outcomes |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 16, 2022 |
| Est. completion date |
April 2026 |
Study information
| Verified date |
November 2023 |
| Source |
SpineZone Medical Fitness, Inc |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
SpineZone is an innovative physical therapy program with its focus on treatment of cervical,
thoracic, and lumbar conditions through the use of a multi-disciplinary, technology enabled
platform. Standard physical therapy modalities including exercise-based rehabilitation as
well as patient education on a healthy lifestyle (sleep, nutrition, posture) are employed as
part of the standard treatment. As nutrition is a key element in modulating muscle growth and
function in response to exercise, providing patients with appropriate access to nutritional
supplements that meet the metabolic demands of our exercise program are potentially important
to our clinical outcomes.
Description:
Low back pain manifests itself clinically with pain, loss of strength, difficulty with normal
posture, and decreased range of motion. In as many as 60-85% cases, LBP will become a chronic
condition, requiring long term care, and even surgery.
Conservative therapy is typically administered until it's no longer a viable option, after
which surgical options are considered. Conservative therapy includes physical therapy,
medication, steroid injections etc. Physical therapy and exercises are especially central to
conservative therapy. Numerous exercise and therapy protocols have been designed with the
goal to improve low back muscle strength, thereby alleviating symptoms, and potentially
underlying cause of the pathology.
As nutrition is a key element in modulating muscle growth and function in response to
exercise, providing patients with appropriate access to nutritional supplements that meet the
metabolic demands of our exercise program are potentially important to our clinical outcomes.
The project specifically aims to assess the effect of ensuring adequate nutritional
availability of protein, as protein shake, as part of their standard care for treatment of
low back pain typically 4-12 weeks duration. In this experiment, we will compare muscle
structure and health and correlate improvements with patient-specific characteristics such as
demographics, medical history, medication usage, treatment expectations, and symptom
severity. Subsequently, this information will enable us to gain valuable insight into
physiological response of pathological tissue, and potentially, develop optimal exercise
plans to maximally benefit these patients.
AIMS OF THE STUDY
- To evaluate the adherence and compliance of patients taking a protein nutritional
supplement in this patient population.
- To evaluate the effectiveness of protein nutritional supplementation on improving
clinical outcomes.
- Identify patients (based on patient specific predictors who are most likely to succeed
with the addition of nutritional supplementation. The goal of this project is to assess
the impact of a nutritional protein supplement on clinical outcomes in individuals with
spine pain.
RESEARCH PARTICIPANTS We will recruit up to 100 individuals with LBP of > 3months duration
that have been identified by the care providers (ie. Primary care physical, orthopaedic
surgeon, or other) to be appropriate and safe for participation in a physical rehabilitation
program with nutritional supplementation at SpineZone.
Upon initial evaluation at the SpineZone clinic with a Physical Therapist, participants will
be offered the opportunity participate in the study and may receive the protein supplement as
part of their standard care. Potentially interested patients will be screened by inclusion
and exclusion criteria and as such, written informed consent will be obtained from each
patient.
Patients will then be randomly assigned to the treatment (protein supplement) or control
group (no protein supplement) and commence their prescribed rehabilitation treatment as per
therapist recommendation. Individuals in the randomly assigned supplementation group will be
provided the supplement and will be instructed on its use (dosage and frequency).
CONSENT All guidelines for proper consenting will be observed. Consenting will be done in a
private room prior to any procedures being performed. Patients will be given ample time to
review the document and ask questions. All study procedures will be thoroughly explained and
all questions will be answered. Patients will not be placed under any pressure to participate
in the study. Consent forms will be obtained by the investigators of the study and/or the
study coordinator in the SpineZone clinics.
Withdrawal from the study: If the patient decides at any point to withdraw from the study,
they can do so without any of the benefits to which they are entitled changing.
RISK/BENEFITS RATIO The risks to the patients will be minimal. Although there is, future
patients may benefit from improvements to surgical procedures and more effective
rehabilitation programs which will be derived from patient outcomes.
DATA PRIVACY AND CONFIDENTIALITY A confidentiality breach is a risk associated with data
review research; however every measure will be instituted to ensure that patient information
is kept confidential. Data analysis worksheets will be kept separate from EMR records. No
subject public health information will be collected or shared.
