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

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787094
• Other study ID #: KA-20031
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: October 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Yoga
Yoga
• Spinal Stabilization Exercise
Spinal Stabilization Exercise

Locations

Country	Name	City	State
Turkey	Özlem Ülger	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes, through study completion, an average of 8 weeks, Change from pain intensity
Primary	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.	5 minutes, through study completion, an average of 8 weeks, Change from disability
Primary	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.	10 minutes, through study completion, an average of 8 weeks, Change from Functional status and performance
Secondary	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.	5 minutes, through study completion, an average of 8 weeks, Change from deep muscle activation
Secondary	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.	5 minutes, through study completion, an average of 8 weeks, Change from kinesiophobia
Secondary	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".	5 minutes, through study completion, an average of 8 weeks, Change from Baseline sleep quality
Secondary	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.	15 minutes, through study completion, an average of 8 weeks, Change from Baseline metabolic capacity.