Yeditepe University
Istanbul, Ataşehir, Turkey (Türkiye)
NCT Number: NCT06099470
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Istanbul, Ataşehir, Turkey (Türkiye)
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):
30 seconds hold for each exercise, 3 cycles.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patient education, core stabilization exercises, strengthening exercises, stretching exercises
Pre-recording non-synchronized telerehabilitation program (NSTP)
Home non-supervised control group (HCG)
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.
Time frame: 12 weeks
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
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 (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 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.
Yeditepe University
Other
Investigation of the Effects of Synchronized and Non-synchronized Telerehabilitation Programs in the Management of Chronic Non-specific Low Back Pain.
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