Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099470
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2023-09-19
Brief Title:
Investigation of the Effects of Telerehabilitation Groups for Chronic Non-specific Low Back Pain
Sponsor:
Yeditepe University
Organization:
Yeditepe University
Study Overview
Official Title:
Investigation of the Effects of Synchronized and Non-synchronized Telerehabilitation Programs in the Management of Chronic Non-specific Low Back Pain
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
1 Real-time synchronized telerehabilitation program STP n24
2 Pre-recording non-synchronized telerehabilitation program NSTP n24
3 Home non-supervised control group HCG n24
Sample Size Calculation
An adequate sample size was calculated using Gpower 3197 Statistical test fixed effects one-way ANOVA the probability for alpha error α at 005 large effect size f 04 power 08 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 n24
Method
Intervention
The three groups received a video conference education session The content of the session was anatomy and physiology of the musculoskeletal structure and kinesiology of the lumbar region In addition they were educated about the principles of pain possible causes for the CNLBP and how to manage CNLBP correct posture and life modifications
Subjects in the STP and NSTP received the same exercises based on core stabilization and stretching but with different method
1 STP group will benefit from individual exercise session through real-time video calls where the therapist demonstrates the exercises and monitor the patient throughout the session
2 NSTP group will benefit from thoroughly instructional videos that describe every step of each exercise and will be followed up weekly through a video call to monitor compliance and answer questions
3 HCG group will receive a PDF file that includes the same exercises with written instructions However no further interventions nor follow-ups will be available for the HCG
Protocol
The exercise protocol table1 will be as follow with total duration of 44 minutes
Warm-up 5 minutes Head tilt head rotation shoulder circles chest stretch side bend hip circles torso twist forward bend Cat-cow
Stabilization exercises 25 minutes
1 Level one Tabletop with single knee and hip flexion 4-point kneeling with single leg stretch Bridge One leg stretch Straight leg side lifts Sit-ups with lumbar region fixed on the floor
2 Level two Tabletop with step knee and hip flexion 4-point kneeling with single-leg rise Bridge with leg stretch One leg stretch with knee extension Straight leg side lifts with contralateral adduction Sit-ups reach wrists to the knees
3 Level three Tabletop with double knee and hip flexion 4-point kneeling with contralateral arm and leg raise Bridge with leg stretch and hold One leg stretch hold and alternate knee extension Straight leg side lifts adduct and hold Sit-ups arms crossed over the chest
10 repetitions 10 seconds rest intervals 3 sets Cooldown and stretching exercises 14 minutes quadriceps stretch kneeling hip flexor stretch sitting adductor stretch seated hip and ITB stretch gluteal stretch in prone position piriformis stretch hamstring-gastrocnemius stretch with a band abdominal stretch bend forward stretch
30 seconds hold for each exercise 3 cycles
1 Real-time synchronized telerehabilitation program STP n24
2 Pre-recording non-synchronized telerehabilitation program NSTP n24
3 Home non-supervised control group HCG n24
Sample Size Calculation
An adequate sample size was calculated using Gpower 3197 Statistical test fixed effects one-way ANOVA the probability for alpha error α at 005 large effect size f 04 power 08 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 n24
Method
Intervention
The three groups received a video conference education session The content of the session was anatomy and physiology of the musculoskeletal structure and kinesiology of the lumbar region In addition they were educated about the principles of pain possible causes for the CNLBP and how to manage CNLBP correct posture and life modifications
Subjects in the STP and NSTP received the same exercises based on core stabilization and stretching but with different method
1 STP group will benefit from individual exercise session through real-time video calls where the therapist demonstrates the exercises and monitor the patient throughout the session
2 NSTP group will benefit from thoroughly instructional videos that describe every step of each exercise and will be followed up weekly through a video call to monitor compliance and answer questions
3 HCG group will receive a PDF file that includes the same exercises with written instructions However no further interventions nor follow-ups will be available for the HCG
Protocol
The exercise protocol table1 will be as follow with total duration of 44 minutes
Warm-up 5 minutes Head tilt head rotation shoulder circles chest stretch side bend hip circles torso twist forward bend Cat-cow
Stabilization exercises 25 minutes
1 Level one Tabletop with single knee and hip flexion 4-point kneeling with single leg stretch Bridge One leg stretch Straight leg side lifts Sit-ups with lumbar region fixed on the floor
2 Level two Tabletop with step knee and hip flexion 4-point kneeling with single-leg rise Bridge with leg stretch One leg stretch with knee extension Straight leg side lifts with contralateral adduction Sit-ups reach wrists to the knees
3 Level three Tabletop with double knee and hip flexion 4-point kneeling with contralateral arm and leg raise Bridge with leg stretch and hold One leg stretch hold and alternate knee extension Straight leg side lifts adduct and hold Sit-ups arms crossed over the chest
10 repetitions 10 seconds rest intervals 3 sets Cooldown and stretching exercises 14 minutes quadriceps stretch kneeling hip flexor stretch sitting adductor stretch seated hip and ITB stretch gluteal stretch in prone position piriformis stretch hamstring-gastrocnemius stretch with a band abdominal stretch bend forward stretch
30 seconds hold for each exercise 3 cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None