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

Not Applicable

Completed

• Conditions: Chronic Low-back Pain

• Registration Number: NCT04643756
• Lead Sponsor: Pamukkale University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Primary Completion: 2021-02-01
• Study Completion: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Emine Aslan Telci; 🇹🇷 Denizli, Turkey