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

March 1, 2024 updated by: Muzeyyen Oz, Hacettepe University

Bel Ağrılı Bireylerde Egzersizlerin Uzun Dönem Devamlılığının Değerlendirilmesi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey, 06100
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: exercise
All exercises programs will applied two sessions per week, totally eight week..
Active Comparator: 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.
Other: exercise
All exercises programs will applied two sessions per week, totally eight week..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline in pain intensity at 8 weeks, 6 and 12 month follow-up.
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.
change from baseline in functional status at 8 weeks, 6 and 12 month follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline in life quality levels at 8 weeks, 6 and 12 month follow-up.
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.
Change from baseline in exercise compliance at 8 weeks, 6 and 12 month follow-up.
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.
Change from baseline in gait at 8 weeks, 6 and 12 month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: Ozlem ULGER, Proffessor, Hacettepe University
  • Principal Investigator: Muzeyyen OZ, MSc, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

March 21, 2021

First Submitted That Met QC Criteria

March 27, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 19/602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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