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Completed

NCT Number: NCT04824547

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

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

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Key information

Conditions

Chronic Low-back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Altindag, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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

Primary outcomes

  1. Changes in pain severity

    Time frame: 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.

  2. Changes of functional status

    Time frame: 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 outcomes

  1. Changes in quality of life

    Time frame: 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.

  2. Changes in Exercise Compliance

    Time frame: 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.

  3. Changes in the gait

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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