search
Back to results

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

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
conventional physiotherapy
conventional physiotherapy plus kinesiotaping
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring chronic low back pain, kinesiotape, physiotherapy, awareness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emine Aslan Telci

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional Physiotherapy

Conventional Physiotherapy + Kinesiotaping

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Repeated 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 weeks
Hospital 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 weeks
Fear-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 weeks
Timed Up and Go Test
Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
Modified Schober Test
Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.
Roland Morris Disability Questionnaire.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2020
Last Updated
September 3, 2021
Sponsor
Pamukkale University
search

1. Study Identification

Unique Protocol Identification Number
NCT04643756
Brief Title
Investigation of the Effects of Two Different Treatment Programs on Chronic Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
chronic low back pain, kinesiotape, physiotherapy, awareness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Physiotherapy + Kinesiotaping
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
Classical electrotherapy method consisting of tens, hotpack and ultrasound.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy plus kinesiotaping
Intervention Description
Conventional physiotherapy plus kinesiotaping
Primary Outcome Measure Information:
Title
Pain assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Description
Visual Analogue Scale (VAS): The patient is asked to mark the pain felt on a 10 cm.
Time Frame
Baseline, 3 weeks, 6 weeks
Title
Awareness Assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Description
Fremantle Back Awareness Questionnaire (FreBAQ): FreBAQwill be used for awareness.
Time Frame
Baseline, 3 weeks, 6 weeks
Title
Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks
Description
Repeated Sit-to-Stand Test
Time Frame
Baseline, 3 weeks, 6 weeks
Title
Assessment of depression and anxiety level Change from baseline at 3 weeks and Change from baseline at 6 weekschanging from baseline at 6 weeks
Description
Hospital and Anxiety Depression Scale (HADS):Anxiety and depression levels will be evaluated subjectively with the Hospital Anxiety and Depression Scale.
Time Frame
Baseline, 3 weeks, 6 weeks
Title
Assessing Kinesophobia Change from baseline at 3 weeks and Change from baseline at 6 weeks
Description
Fear-Avoidance Beliefs Questionnaire (FABQ):It measures the patient's fear of movement caused by low back pain.
Time Frame
Baseline, 3 weeks, 6 weeks
Title
Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
Description
Timed Up and Go Test
Time Frame
Baseline, 3 weeks, 6 weeks
Title
Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks
Description
Modified Schober Test
Time Frame
Baseline, 3 weeks, 6 weeks
Title
Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.
Description
Roland Morris Disability Questionnaire.
Time Frame
Baseline, 3 weeks, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine PT Aslan Telci, Prof. Dr
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Emine Aslan Telci
City
Denizli
ZIP/Postal Code
20100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27634093
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.
Results Reference
background
PubMed Identifier
21430611
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.
Results Reference
background
PubMed Identifier
25202177
Citation
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.
Results Reference
background
PubMed Identifier
30526011
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: 10.1177/0269215518817804. Epub 2018 Dec 11.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs