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

NCT ID: NCT04824547

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2024-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type OTHER

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

Interventions

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exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Muzeyyen Oz

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muzeyyen OZ, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ozlem ULGER, Proffessor

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Altindag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29067082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28631003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32870936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31666220 (View on PubMed)

Other Identifiers

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GO 19/602

Identifier Type: -

Identifier Source: org_study_id

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