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

Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04824547
Enrollment
104
Registered
2021-04-01
Start date
2021-09-30
Completion date
2024-03-01
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain

Keywords

exercise, pain, yoga, function

Brief summary

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

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.

Interventions

OTHERexercise

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

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in pain severitychange 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 statuschange 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

MeasureTime frameDescription
Changes in quality of lifeChange 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 ComplianceChange 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 gaitChange 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026