Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals

Sponsor

Hacettepe University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04824547

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Identification of the long term effects of exercises in individuals with low back pain.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain	Other: exercise	N/A

Detailed Description

Individuals with low back pain who will participate in the study will be divided into two groups. In the stabilization exercise group will be instructed to perform spinal stabilization exercises and in the yoga group will be instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The intensity of the pain will be evaluated through visual analog scale, functional status and quality of life will be evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. The exercise adherence will evaluated Exercise Adherence Rating Scale (EARS). The time-distance characteristics of the gait will be evaluated by the OPTOGAIT photoelectric cell (OPTOGait, Microgate, Italy, 2010) and the treadmill system. Assessments will be repeated before, after the treatment, 6 and 12 month follow-up. Also,the number of back pain attacks of the individuals will be questioned and recorded.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi

Actual Study Start Date :

Sep 30, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stabilization exercise group Spinal stabilization exercise will be applied all patients accompanied by physiotherapist. Sessions will be included selected exercises according to motor learning phases.	Other: exercise All exercises programs will applied two sessions per week, totally eight week..
Active Comparator: yoga group Yoga program will be applied all patients in this group accompanied by physiotherapist. Sessions will be included selected breathing exercises, warm up, asana and relaxation.	Other: exercise All exercises programs will applied two sessions per week, totally eight week..

Arm

Intervention/Treatment

Active Comparator: Stabilization exercise group

Spinal stabilization exercise will be applied all patients accompanied by physiotherapist. Sessions will be included selected exercises according to motor learning phases.

Other: exercise

All exercises programs will applied two sessions per week, totally eight week..

Active Comparator: yoga group

Yoga program will be applied all patients in this group accompanied by physiotherapist. Sessions will be included selected breathing exercises, warm up, asana and relaxation.

Other: exercise

All exercises programs will applied two sessions per week, totally eight week..

Outcome Measures

Primary Outcome Measures

Changes in pain severity [change from baseline in pain intensity at 8 weeks, 6 and 12 month follow-up.]
Patients' average pain intensities will be assessed by Visual Analog Scale (VAS). Participants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right.
Changes of functional status [change from baseline in functional status at 8 weeks, 6 and 12 month follow-up.]
Patient's pain related functional status will be measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The total score is between 0 and 100. The higher the score, the higher the level of disability.

Secondary Outcome Measures

Changes in quality of life [Change from baseline in life quality levels at 8 weeks, 6 and 12 month follow-up.]
Health-related quality of life will be assessed by Nottingham Health Profile (NHP). The NHP contain 38 questions in 6 subareas: pain, physical abilities, energy level, sleep, social isolation and emotional reaction. The scores range from 0 to 100, with each question assigned a weighted value; the sum of all weighted values in a given sub-area adds up to 100. Lower scores denoting a better quality of life.
Changes in Exercise Compliance [Change from baseline in exercise compliance at 8 weeks, 6 and 12 month follow-up.]
Exercise Adherence Rating Scale (EARS) will be used to evaluate the exercise compliance of individuals. The result score of the questionnaire is between 0 and 64. A higher score indicates greater compliance with exercise.
Changes in the gait [Change from baseline in gait at 8 weeks, 6 and 12 month follow-up.]
The gait of individuals will be evaluated by the valid and reliable OPTOGait photoelectric cell and the treadmill system. The gait of individuals on flat ground at their own pace will be recorded for 1 minute. The effects of the exercises on gait will be determined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be low back pain at least 3 months
Must be visual analog scale rating 3 or more

Exclusion Criteria:

History of any lumbar spine surgery
Severe/progressive scoliosis
Spinal stenosis
Spondylolisthesis
Cancer
Diabetes
Metabolic syndrome
History of exercise programs or yoga at least 12 weeks before the onset of study