An interventional study of Real-time synchronized telerehabilitation program (STP). and Pre-recording non-synchronized telerehabilitation program (NSTP) in Chronic Non-specific Low Back Pain, sponsored by Yeditepe University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Yeditepe University · Not applicable, Interventional, and Treatment
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.
This study is a randomized control trial with two intervention groups and one control group with total sample size of 72:
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:
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.
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):
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.
Yeditepe University is the lead sponsor of 131 studies on the registry; 29 are open to participants now.
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Exclusion criteria
Subjects in this group will have face to face real-time video tele-habilitation sessions twice a week using Zoom
Other: Real-time synchronized telerehabilitation program (STP).
Subjects in this group will receive their therapeutic exercises through instructional videos sent via Email or WhatsAPP.
Other: Pre-recording non-synchronized telerehabilitation program (NSTP)
Minimum intervention which is a PDF file containing the same exercises with no follow ups.
Other: Home non-supervised control group (HCG)
patient education, core stabilization exercises, strengthening exercises, stretching exercises
Pre-recording non-synchronized telerehabilitation program (NSTP)
Home non-supervised control group (HCG)
Visual Analog Scale
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.
Time frame: 12 weeks
Roland Morris Disability Questionnaire
A sensitive and reliable evaluation tool, to measure disability in patients with chronic non-specific low back pain. It contains a 24-item scale with a total score ranging from 0 (no disability) to 24 (high disability). The questionnaire was prepared in the questionnaire was delivered electronically as checkboxes question on the prepared assessment google forms. Patients were asked to only choose the sentences that describes how they feel today and skip the sentences that does not.
Time frame: 12 weeks
Oswestry Disability Index
Is a gold standard, valid questionnaire, which assesses disability in ten distinct parts: pain intensity, patient personal care, lifting, walking, sitting, standing, sleeping, social life, sex life and travelling. Each statement is scored from 0 to 5 with higher scores demonstrating more disability. The questionnaire was prepared and delivered electronically as ten multiple choice questions on the prepared assessment google forms. Patients were asked to choose the part that most closely describes how they feel today.
Time frame: 12 weeks
Tampa Scale for Kinesiophobia
Tampa Scale for Kinesiophobia (TSK) was used. Which is a reliable 17-item scale to measure fear of movement and injury in patients with CNLBP. Each item ranges from 1 to 4 points, with 1 point for "total disagree," to 4 points for "total agree". The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia
Time frame: 12 weeks
SF-12 Health Questionnaire
SF-12 Health Questionnaire was used. Which is a questionnaire that measures the quality of life, by assessing the impact of health on everyday activities. It uses the same eight domains as the SF-36: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities because of emotional problems, vitality (energy and fatigue), general health perceptions. The questionnaire was prepared and delivered electronically as 12 multiple choice questions on the prepared assessment google forms.
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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