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NCT Number: NCT03676062

The Effect of Yoga and Stabilization Exercise in Patients With Chronic Low Back Pain

Identification of the effects of yoga, stabilization exercise and home exercise approaches on pain, function,stress and quality of life in individuals with low back pain.

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Key information

Conditions

Chronic Low Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University, Health Sciences Faculty

Ankara, Altındag, 06100, Turkey (Türkiye)

About this study

44 patients participating in the study were divided three groups. The patients in the stabilization exercise group were instructed to perform hotpack, Trans-cutaneous Electric Nerve Stimulation (TENS) and spinal stabilization exercises, the patients in the yoga group were instructed to perform yoga program consisting of breathing, relaxation and flexibility exercises. The patients in the home exercise group were instructed to perform stabilization exercise. The severity of the pain evaluated through visual analog scale, functional status and quality of life evaluated through Oswestry Disability Index(ODI), Nottingham Health Profile (NHP), respectively. Assessments were repeated before and after the treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 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

Treatment and study plan

Exercise

Other

All exercises programs applied three sessions per week, totally six week.

Primary outcomes

  1. Changes in pain severity

    Time frame: change from baseline in pain severity at 6 weeks.

    Patients' average resting and activity pain intensities assessed by Visual Analog Scale.

    The visual analog scale is an 11-point scale ranging from 0 to 10, in which 0 defines absence of pain and 10 describes unbearable pain. Participants asked to rate the average pain levels a horizontal 10 cm straight line on a white sheet from, before and after treatment.

Secondary outcomes

  1. Changes in quality of life

    Time frame: Change from baseline in life quality levels at 6 weeks.

    Health-related quality of life assessed by Nottingham Health Profile (NHP). The NSP 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 subarea adds up to 100. Lower scores denoting a better quality of life.

  2. Changes of functional status

    Time frame: change from baseline in functional status at 6 weeks

    Patient's permanent functional disability 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.

  3. Changes of stress level

    Time frame: change from baseline in stress level at 6 weeks

    Patients' stress levels were measured with State Trait Anxiety Inventory. State anxiety scale questions how does a person feel in a given moment and situation, mean while trait anxiety scale questions how does a person usually feel without depending on situation and moment. Scale contain 40 questions, minimum and maximum score 20-80, respectively. Scores below 36 accepted as "no-anxiety", between 37-42 accepted as "low-anxiety", 42 and above accepted as "high-anxiety.

  4. Changes of stress related biomarkers

    Time frame: change from baseline in serum level at 6 weeks

    Venous blood samples were taken from antecubital area between 08.30-09.00 am and stress related markers (DHEA(S) and cortisol) were analyzed. All analyses were performed in the same laboratory.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Kronik Bel Ağrılı Bireylerde Yoga ve Spinal Stabilizasyon Egzersizlerinin Ağrı, Fonksiyon ve Stres Üzerine Etkisinin Karşılaştırılması

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2018
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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