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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04643756
Enrollment
52
Registered
2020-11-25
Start date
2020-01-01
Completion date
2021-08-01
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain

Keywords

chronic low back pain, kinesiotape, physiotherapy, awareness

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.

Interventions

OTHERconventional physiotherapy

Classical electrotherapy method consisting of tens, hotpack and ultrasound.

OTHERconventional physiotherapy plus kinesiotaping

Conventional physiotherapy plus kinesiotaping

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeksBaseline, 3 weeks, 6 weeksVisual 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 weeksBaseline, 3 weeks, 6 weeksFremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness.
Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeksBaseline, 3 weeks, 6 weeksRepeated Sit-to-Stand Test
Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeksBaseline, 3 weeks, 6 weeksHospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale.
Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeksBaseline, 3 weeks, 6 weeksFear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain.
Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeksBaseline, 3 weeks, 6 weeksTimed Up and Go Test
Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeksBaseline, 3 weeks, 6 weeksModified Schober Test
Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.Baseline, 3 weeks, 6 weeksRoland Morris Disability Questionnaire.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026