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

September 3, 2021 updated by: Özgür Nadiye Karaman, Pamukkale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20100
        • Emine Aslan Telci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Physiotherapy
Classical electrotherapy method consisting of tens, hotpack and ultrasound. Procedure/Device: Conventional Physiotherapy Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm2 and duration of 5 minute. TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
Other: conventional physiotherapy
Classical electrotherapy method consisting of tens, hotpack and ultrasound.
ACTIVE_COMPARATOR: Conventional Physiotherapy + Kinesiotaping
Kinesiotaping application in addition to classical electrotherapy method consisting of tens, hotpack and ultrasound.It will be applied to reduce pain, increase proprioception and awareness. Kinesiotaping will be re-applicated every day. Space taping will be applied to the waist area. Space taping creates a vacuum effect on the skin, loosening the adhesions in the tissue layers. With this lifting effect, it creates a space under the skin, causing an increase in circulation and a decrease in pain. Four pieces of I-tape will be used for taping. The middle point of the first tape will be attached with maximum tension. The ends of the tape will be tensionless. The second tape will also be applied at a 90 degree angle. The third and fourth tapes will be taped at an angle of 45 degrees.
Other: conventional physiotherapy plus kinesiotaping
Conventional physiotherapy plus kinesiotaping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 weeks, 6 weeks
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.
Baseline, 3 weeks, 6 weeks
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
Baseline, 3 weeks, 6 weeks
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.
Baseline, 3 weeks, 6 weeks
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.
Baseline, 3 weeks, 6 weeks
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
Baseline, 3 weeks, 6 weeks
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
Baseline, 3 weeks, 6 weeks
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.
Baseline, 3 weeks, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Study Director: Emine PT Aslan Telci, Prof. Dr, Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

February 1, 2021

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (ACTUAL)

November 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60116787-020/62195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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