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

Chronic Low-back Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643756
• Other study ID #: 60116787-020/62195
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: August 1, 2021

Study information

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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• conventional physiotherapy
Classical electrotherapy method consisting of tens, hotpack and ultrasound.
• conventional physiotherapy plus kinesiotaping
Conventional physiotherapy plus kinesiotaping

Locations

Country	Name	City	State
Turkey	Emine Aslan Telci	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30. — View Citation

Li Y, Yin Y, Jia G, Chen H, Yu L, Wu D. Effects of kinesiotape on pain and disability in individuals with chronic low back pain: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2019 Apr;33(4):596-606. doi: 10.1177/0269 — View Citation

Nelson NL. Kinesio taping for chronic low back pain: A systematic review. J Bodyw Mov Ther. 2016 Jul;20(3):672-81. doi: 10.1016/j.jbmt.2016.04.018. Epub 2016 Apr 27. Review. — View Citation

Paoloni M, Bernetti A, Fratocchi G, Mangone M, Parrinello L, Del Pilar Cooper M, Sesto L, Di Sante L, Santilli V. Kinesio Taping applied to lumbar muscles influences clinical and electromyographic characteristics in chronic low back pain patients. Eur J Phys Rehabil Med. 2011 Jun;47(2):237-44. Epub 2011 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks	Visual Analogue Scale (VAS): The patient is asked to mark the pain felt on a 10 cm.	Baseline, 3 weeks, 6 weeks
Primary	Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks	Fremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness.	Baseline, 3 weeks, 6 weeks
Primary	Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks	Repeated Sit-to-Stand Test	Baseline, 3 weeks, 6 weeks
Primary	Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks	Hospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale.	Baseline, 3 weeks, 6 weeks
Primary	Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks	Fear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain.	Baseline, 3 weeks, 6 weeks
Primary	Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks	Timed Up and Go Test	Baseline, 3 weeks, 6 weeks
Primary	Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks	Modified Schober Test	Baseline, 3 weeks, 6 weeks
Primary	Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.	Roland Morris Disability Questionnaire.	Baseline, 3 weeks, 6 weeks