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

NCT04824547 | Completed

• 1 other identifier: GO 19/602
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Low-back Pain

Keywords

exercise; pain; yoga; function

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (3)

• Changes in quality of life

  Change from baseline in life quality levels at 8 weeks, 6 and 12 month follow-up.

• Changes in Exercise Compliance

  Change from baseline in exercise compliance at 8 weeks, 6 and 12 month follow-up.

• Changes in the gait

  Change from baseline in gait at 8 weeks, 6 and 12 month follow-up.

Study Arms (2)

Stabilization exercise group

ACTIVE COMPARATOR

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

Other: exercise

yoga group

ACTIVE COMPARATOR

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

Interventions

exercise OTHER

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

Stabilization exercise group; yoga group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Altindag, 06100, Turkey (Türkiye)

Location

Related 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.

  PMID: 29067082 BACKGROUND

• 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.

  PMID: 28631003 BACKGROUND

• 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.

  PMID: 32870936 BACKGROUND

• 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.

  PMID: 31666220 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Muzeyyen OZ, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ozlem ULGER, Proffessor

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: April 1, 2021
• Study Start: September 30, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)