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

Chronic Low-back Pain Clinical Trial

Official title:

Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824547
• Other study ID #: GO 19/602
• Status: Completed
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• exercise
All exercises programs will applied two sessions per week, totally eight week..

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Physical Therapy and Rehabilitation	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664. — View Citation

Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30. — View Citation

Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20. — View Citation

Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Sep 1;15(9):e0238544. doi: 10.1371/journal.pone.0238544. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pain severity	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.	change from baseline in pain intensity at 8 weeks, 6 and 12 month follow-up.
Primary	Changes of functional status	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.	change from baseline in functional status at 8 weeks, 6 and 12 month follow-up.
Secondary	Changes in quality of life	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.	Change from baseline in life quality levels at 8 weeks, 6 and 12 month follow-up.
Secondary	Changes in Exercise Compliance	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.	Change from baseline in exercise compliance at 8 weeks, 6 and 12 month follow-up.
Secondary	Changes in the gait	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.	Change from baseline in gait at 8 weeks, 6 and 12 month follow-up.