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

19 oktober 2021 bijgewerkt door: Ozlem Ulger, Hacettepe University

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.

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

28

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Kalkoen
    • Altındağ
      • Ankara, Altındağ, Kalkoen, 06100
        • Özlem Ülger

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Yoga Group
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.
Ander: Yoga
Yoga
Experimenteel: Spinal Stabilization Exercise Group

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.
Ander: Spinal Stabilization Exercise
Spinal Stabilization Exercise

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Intensity
Tijdsspanne: 15 minutes, through study completion, an average of 8 weeks, Change from 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
Tijdsspanne: 5 minutes, through study completion, an average of 8 weeks, Change from disability

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
Tijdsspanne: 10 minutes, through study completion, an average of 8 weeks, Change from Functional status and 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Deep muscle activation
Tijdsspanne: 5 minutes, through study completion, an average of 8 weeks, Change from 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
Kinesiophobia
Tijdsspanne: 5 minutes, through study completion, an average of 8 weeks, Change from 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
Sleep quality
Tijdsspanne: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline 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
Metabolic Capacity
Tijdsspanne: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hacettepe University

Onderzoekers

  • Hoofdonderzoeker: Ozlem Ulger, Prof, Hacettepe University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 februari 2021

Primaire voltooiing (Werkelijk)

15 augustus 2021

Studie voltooiing (Werkelijk)

15 augustus 2021

Studieregistratiedata

Eerst ingediend

8 februari 2021

Eerst ingediend dat voldeed aan de QC-criteria

5 maart 2021

Eerst geplaatst (Werkelijk)

8 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 oktober 2021

Laatste update ingediend die voldeed aan QC-criteria

19 oktober 2021

Laatst geverifieerd

1 oktober 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KA-20031

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

No.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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