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The Effect of Yoga and Stabilization Exercises in Individuals With Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Yoga
Spinal Stabilization Exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring spinal stabilization exercise, yoga, low back pain

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic non-specific low back pain diagnosis
  • Having pain that persists for at least 12 weeks
  • 25-65 age range

Exclusion Criteria:

  • Scoliosis with a cobb angle of more than 20º
  • History of previous surgery for the lumbal region
  • Having an additional diagnosis such as spondylolisthesis, spinal stenosis, spondylolysis
  • Presence of neurological deficits
  • Metastatic state presence
  • Presence of neurological deficits due to diabetes
  • Presence of metabolic problems such as thyroid, hypertension, coronary artery disease
  • The presence of inflammatory problems involving the spine

Sites / Locations

  • Özlem Ülger

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Yoga Group

Spinal Stabilization Exercise Group

Arm Description

The sessions will begin with breathing exercises in standing, sitting, supine and prone positions, and these exercises will be applied for about 10 minutes. After the breathing exercises, the sudden relaxation technique, which will take 2-3 minutes, firstly contracting the whole body from the feet to the head and then completely relaxing it.

Spinal stabilization exercises will be applied to the individuals in this group for 8 weeks / 2 days a week, approximately 50-60 minutes a day under the supervision of a physiotherapist. Spinal stabilization exercises will be progressed in 3 phases by gradually increasing the difficulty.

Outcomes

Primary Outcome Measures

Pain Intensity
Pain intensity of participants will be evaluated with visual analog scale (VAS). Paricipants 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. VAS scored between 0-10 cm.
Disability Severity
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 travelling. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound. The Oswestry Disability Index is scored between 0-50 points. An increase in score indicates a poor result. Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.
Funcitonal Performance
Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.

Secondary Outcome Measures

Deep muscle activation
To evaluate the transversus abdominis muscle activation, the stabilizer biofeedback device is placed under the abdomen, just below the spina iliaca anterior superior, while the patient is in the prone position. The cuff of the device is inflated to 70 mmHg, the patient is asked to breathe and pull the abdomen up and in while exhaling, but the patient is warned not to make pelvis and spine movement. In the meantime, how much the pressure has changed is observed from the stabilizer device. In the test, the average of 3 repetitions will be recorded. With successful measurement, the pressure is expected to drop between 6 and 10 mm-Hg.
Kinesiophobia
Fear-Avoidance-Beliefs Questionnaire will be applied to evaluate kinesiophobia which is fear of movement due to low back pain. This questionnaire has 2 sub-sections related to physical activity and work. There are 4 questions scored in the physical activity section and 7 questions in the work section. 0-6 points are obtained for each question. The total score will be recorded. Physical Activity sub-section scored between 0-24 points. Work sub-sections scored between 0-42 points. The higher the score, the higher the kinesiophobia.
Sleep quality
The Pittsburg Sleep Quality Index will be used to evaluate sleep quality. This questionnaire evaluates sleep quality and disturbance over the past month. The scale consists of 7 subcomponents: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medication, and Daytime Dysfunction. Each component is scored between 0-3 points. The total score of the 7 components gives the total score of the scale. The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality".
Metabolic Capacity
Metabolic capacity evaluation will be performed according to 6 Minute Walk Test. Individuals are asked to walk as fast as possible for 6 minutes without running on the 30 m long corridor. The test is started, the number of rounds is recorded while the patient is walking. Heart rate, blood pressure, oxygen saturation and respiratory frequency will be evaluated and recorded at first, at the end of the test and one minute after. Walking distance is recorded in meters.

Full Information

First Posted
February 8, 2021
Last Updated
October 19, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04787094
Brief Title
The Effect of Yoga and Stabilization Exercises in Individuals With Chronic Low Back Pain
Official Title
The Effect of Yoga and Stabilization Exercises on Pain, Functional Status, Metabolic Capacity and Sleep Quality in Individuals With Chronic Low Back Pain: A Randomized, Crossover Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
August 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Although exercise has been shown to be effective in low back pain in the literature, there is no conclusion about which exercise is superior to the other. Although there are studies showing positive effects of spinal stabilization exercises and yoga approach on pain level, disability level and quality of life in patients with chronic low back pain, studies evaluating the effectiveness in many other aspects are insufficient. Therefore, this study aimed to investigate the effects of spinal stabilization and yoga exercises on pain, functional status, metabolic capacity, kinesophobia and sleep quality in patients with chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
spinal stabilization exercise, yoga, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
The sessions will begin with breathing exercises in standing, sitting, supine and prone positions, and these exercises will be applied for about 10 minutes. After the breathing exercises, the sudden relaxation technique, which will take 2-3 minutes, firstly contracting the whole body from the feet to the head and then completely relaxing it.
Arm Title
Spinal Stabilization Exercise Group
Arm Type
Experimental
Arm Description
Spinal stabilization exercises will be applied to the individuals in this group for 8 weeks / 2 days a week, approximately 50-60 minutes a day under the supervision of a physiotherapist. Spinal stabilization exercises will be progressed in 3 phases by gradually increasing the difficulty.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
Yoga
Intervention Type
Other
Intervention Name(s)
Spinal Stabilization Exercise
Intervention Description
Spinal Stabilization Exercise
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity of participants will be evaluated with visual analog scale (VAS). Paricipants 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. VAS scored between 0-10 cm.
Time Frame
15 minutes, through study completion, an average of 8 weeks, Change from pain intensity
Title
Disability Severity
Description
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 travelling. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound. The Oswestry Disability Index is scored between 0-50 points. An increase in score indicates a poor result. Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from disability
Title
Funcitonal Performance
Description
Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.
Time Frame
10 minutes, through study completion, an average of 8 weeks, Change from Functional status and performance
Secondary Outcome Measure Information:
Title
Deep muscle activation
Description
To evaluate the transversus abdominis muscle activation, the stabilizer biofeedback device is placed under the abdomen, just below the spina iliaca anterior superior, while the patient is in the prone position. The cuff of the device is inflated to 70 mmHg, the patient is asked to breathe and pull the abdomen up and in while exhaling, but the patient is warned not to make pelvis and spine movement. In the meantime, how much the pressure has changed is observed from the stabilizer device. In the test, the average of 3 repetitions will be recorded. With successful measurement, the pressure is expected to drop between 6 and 10 mm-Hg.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from deep muscle activation
Title
Kinesiophobia
Description
Fear-Avoidance-Beliefs Questionnaire will be applied to evaluate kinesiophobia which is fear of movement due to low back pain. This questionnaire has 2 sub-sections related to physical activity and work. There are 4 questions scored in the physical activity section and 7 questions in the work section. 0-6 points are obtained for each question. The total score will be recorded. Physical Activity sub-section scored between 0-24 points. Work sub-sections scored between 0-42 points. The higher the score, the higher the kinesiophobia.
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from kinesiophobia
Title
Sleep quality
Description
The Pittsburg Sleep Quality Index will be used to evaluate sleep quality. This questionnaire evaluates sleep quality and disturbance over the past month. The scale consists of 7 subcomponents: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medication, and Daytime Dysfunction. Each component is scored between 0-3 points. The total score of the 7 components gives the total score of the scale. The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality".
Time Frame
5 minutes, through study completion, an average of 8 weeks, Change from Baseline sleep quality
Title
Metabolic Capacity
Description
Metabolic capacity evaluation will be performed according to 6 Minute Walk Test. Individuals are asked to walk as fast as possible for 6 minutes without running on the 30 m long corridor. The test is started, the number of rounds is recorded while the patient is walking. Heart rate, blood pressure, oxygen saturation and respiratory frequency will be evaluated and recorded at first, at the end of the test and one minute after. Walking distance is recorded in meters.
Time Frame
15 minutes, through study completion, an average of 8 weeks, Change from Baseline metabolic capacity.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic non-specific low back pain diagnosis Having pain that persists for at least 12 weeks 25-65 age range Exclusion Criteria: Scoliosis with a cobb angle of more than 20º History of previous surgery for the lumbal region Having an additional diagnosis such as spondylolisthesis, spinal stenosis, spondylolysis Presence of neurological deficits Metastatic state presence Presence of neurological deficits due to diabetes Presence of metabolic problems such as thyroid, hypertension, coronary artery disease The presence of inflammatory problems involving the spine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özlem Ülger, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Özlem Ülger
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No.

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The Effect of Yoga and Stabilization Exercises in Individuals With Chronic Low Back Pain

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