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

NCT04643756 | Completed

• 1 other identifier: 60116787-020/62195
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

chronic low back pain, kinesiotape, physiotherapy, awareness

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 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.

  Roland Morris Disability Questionnaire.

  Baseline, 3 weeks, 6 weeks

Study Arms (2)

Conventional Physiotherapy

ACTIVE COMPARATOR

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

Conventional Physiotherapy + Kinesiotaping

ACTIVE COMPARATOR

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

Interventions

conventional physiotherapy OTHER

Classical electrotherapy method consisting of tens, hotpack and ultrasound.

Conventional Physiotherapy

conventional physiotherapy plus kinesiotaping OTHER

Conventional physiotherapy plus kinesiotaping

Conventional Physiotherapy + Kinesiotaping

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Emine Aslan Telci

Denizli, 20100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 27634093 BACKGROUND

• 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.

  PMID: 21430611 BACKGROUND

• 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.

  PMID: 25202177 BACKGROUND

• 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.

  PMID: 30526011 RESULT

Study Officials

• Emine PT Aslan Telci, Prof. Dr

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 25, 2020
• Study Start: January 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)