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Completed

NCT Number: NCT04643756

Investigation of the Effects of Two Different Treatment Programs on Chronic Low Back Pain

This study was planned to examine the effects of two different treatment programs on pain intensity, back awareness, functional and psychosocial factors in patients with chronic low back pain.

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Key information

Conditions

Chronic Low-back Pain

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emine Aslan Telci

Denizli, 20100, Turkey (Türkiye)

About this study

Recent study will be carried out on volunteer patients who applied to the Physical Therapy Clinic of "Mugla Sitki Kocman University" Training and Research Hospital, who were diagnosed with chronic non-specific low back pain and who comply with the study criteria.

The sample size has been calculated that 80% power can be obtained at 95% confidence level. It was found that at least 21 cases, a total of 44 cases, were required for each group.

Volunteers will be divided into 2 groups by randomization. Conventional physiotherapy applications will be applied to the control group. In addition to conventional physiotherapy methods, kinesio-taping (KT) will be applied to the study group. Patients in both groups will be treated 5 days a week for a total of 10 sessions for 2 weeks. KT will be renewed in each session on weekdays.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients aged 18 to 60 years with chronic low back pain
  • Those who have complained of low back pain for at least 3 months
  • Individuals whose pain intensity is above 3.5 cm according to VAS
  • Pain and numbness that does not spread to the legs

Exclusion criteria

  • Situations that prevent the evaluation or communication with the individual
  • Illiterate individuals
  • Individuals who have undergone surgical operations on the spine and / or extremities
  • Conditions where specific pathological conditions are proven such as malignant condition, fracture, systemic rheumatoid disease
  • Orthopedic and neurological problems that prevent evaluation and / or treatment
  • Complaints of pain and numbness spreading to the lower extremities
  • Individuals with a diagnosed psychiatric illness
  • Individuals who have received physiotherapy in the last 6 months
  • Individuals who use another treatment method during the study
  • Individuals with musculoskeletal pain in any other part of the body during work
  • Pregnant

Treatment and study plan

Conventional Physiotherapy

Other

Classical electrotherapy method consisting of tens, hotpack and ultrasound.

conventional physiotherapy plus kinesiotaping

Other

Conventional physiotherapy plus kinesiotaping

Primary outcomes

  1. Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Time frame: Baseline, 3 weeks, 6 weeks

    Visual Analogue Scale (VAS): The patient is asked to mark the pain felt on a 10 cm.

  2. Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Time frame: Baseline, 3 weeks, 6 weeks

    Fremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness.

  3. Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Time frame: Baseline, 3 weeks, 6 weeks

    Repeated Sit-to-Stand Test

  4. Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks

    Time frame: Baseline, 3 weeks, 6 weeks

    Hospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale.

  5. Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Time frame: Baseline, 3 weeks, 6 weeks

    Fear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain.

  6. Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Time frame: Baseline, 3 weeks, 6 weeks

    Timed Up and Go Test

  7. Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Time frame: Baseline, 3 weeks, 6 weeks

    Modified Schober Test

  8. Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.

    Time frame: Baseline, 3 weeks, 6 weeks

    Roland Morris Disability Questionnaire.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Investigation of the Effects of Two Different Treatment Programs on Pain Severity, Low Back Awareness, Functional and Psychosocial Factors in Patients With Chronic Low Back Pain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Sep 13, 2021

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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