Investigation of the Effects of Synchronized and Non-synchronized Telerehabilitation Programs in the Management of Chronic Non-specific Low Back Pain.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yeditepe University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale
Study Overview
Brief Summary
The goal of this study is to investigate the efficacy of different internet based delivery methods for patients with chronic non-specific low back pain.
The parameters we want to study is pain, disability, fear of movement, and quality of life.
Detailed Description
This study is a randomized control trial with two intervention groups and one control group with total sample size of 72:
- Real-time synchronized telerehabilitation program (STP). (n=24)
- Pre-recording non-synchronized telerehabilitation program (NSTP). (n=24)
- Home non-supervised control group (HCG). (n=24)
Sample Size Calculation:
An adequate sample size was calculated using G*power 3.1.9.7. Statistical test fixed effects one-way ANOVA, the probability for alpha error (α) at 0.05, large effect size f = 0.4, power = 0.8, and three groups. A total of 66 subjects was calculated as the minimum required sample size. In addition, based on previous studies a dropout rate was set at 10%. Hence, the total sample size was increased to 72. Therefore, each group will have 24 subjects (n=24).
Method:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persisting low back pain for the past 3 months.
- •VAS score of at least
- •Age between 18 and
- •Ability to perform exercises.
- •Internet access.
Exclusion Criteria
- •Pregnancy.
- •History of spinal surgery.
- •History of spinal injury.
- •Misalignment or specific condition in the lumbar region.
- •Inflammatory joint diseases.
- •Any neurological symptoms.
- •Diagnosed osteoporosis.
- •Spondylosis.
- •Radiculopathy in the lumbar region.
- •Having a current inflammation in the trunk, lumbar or pelvic region.
- •Receiving physical therapy or other conventional therapy for LBP in the past 6 months.
- •Regular practice for Pilates or other specific exercise programs in the last 6 months
Arms & Interventions
Real-time synchronized telerehabilitation program (STP).
Subjects in this group will have face to face real-time video tele-habilitation sessions twice a week using Zoom
Intervention: Real-time synchronized telerehabilitation program (STP). (Other)
Pre-recording non-synchronized telerehabilitation program (NSTP)
Subjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.
Intervention: Pre-recording non-synchronized telerehabilitation program (NSTP) (Other)
Home non-supervised control group (HCG)
Minimum intervention which is a PDF file containing the same exercises with no follow ups.
Intervention: Home non-supervised control group (HCG) (Other)
Outcomes
Primary Outcomes
Visual Analog Scale
Time Frame: 12 weeks
is a visual scale with various types to measure the intensity of the pain where 0 is considered no pain and 10 is unbearable pain. VAS can be just a 100mm horizontal line where patients can put a mark anywhere on the line, or graphics indicating the severity of pain. Also, it can be numerical line from 0 to 10 which we intend to use in this thesis.
Secondary Outcomes
- Tampa Scale for Kinesiophobia(12 weeks)
- Oswestry Disability Index(12 weeks)
- SF-12 Health Questionnaire(12 weeks)
- Roland Morris Disability Questionnaire(12 weeks)