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

NCT04787094 | Completed

• 1 other identifier: KA-20031
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

spinal stabilization exercise; yoga; low back pain

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Deep muscle activation

  5 minutes, through study completion, an average of 8 weeks, Change from deep muscle activation

• Kinesiophobia

  5 minutes, through study completion, an average of 8 weeks, Change from kinesiophobia

• Sleep quality

  5 minutes, through study completion, an average of 8 weeks, Change from Baseline sleep quality

• Metabolic Capacity

  15 minutes, through study completion, an average of 8 weeks, Change from Baseline metabolic capacity.

Study Arms (2)

Yoga Group

EXPERIMENTAL

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.

Other: Yoga

Spinal Stabilization Exercise Group

EXPERIMENTAL

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.

Other: Spinal Stabilization Exercise

Interventions

Yoga OTHER

Yoga

Yoga Group

Spinal Stabilization Exercise OTHER

Spinal Stabilization Exercise

Spinal Stabilization Exercise Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Özlem Ülger

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Özlem Ülger, Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Physiotherapist

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 8, 2021
• Study Start: February 15, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)