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CompletedNCT04643756Updated Sep 13, 2021

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

An interventional study of conventional physiotherapy and conventional physiotherapy plus kinesiotaping in Chronic Low-back Pain, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2020, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Low-back Pain

Keywords

  • chronic low back pain, kinesiotape, physiotherapy, awareness
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 52 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherconventional physiotherapy

    Classical electrotherapy method consisting of tens, hotpack and ultrasound.

  • Otherconventional physiotherapy plus kinesiotaping

    Conventional physiotherapy plus kinesiotaping

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 3 weeks, 6 weeks

  2. 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.

    Time frame: Baseline, 3 weeks, 6 weeks

  3. Functional assessment Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Repeated Sit-to-Stand Test

    Time frame: Baseline, 3 weeks, 6 weeks

  4. 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.

    Time frame: Baseline, 3 weeks, 6 weeks

  5. 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.

    Time frame: Baseline, 3 weeks, 6 weeks

  6. Timed Up and Go Test Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Timed Up and Go Test

    Time frame: Baseline, 3 weeks, 6 weeks

  7. Modified Schober Test Change from baseline at 3 weeks and Change from baseline at 6 weeks

    Modified Schober Test

    Time frame: Baseline, 3 weeks, 6 weeks

  8. Disability level Change from baseline at 3 weeks and Change from baseline at 6 weeks.

    Roland Morris Disability Questionnaire.

    Time frame: Baseline, 3 weeks, 6 weeks

07

Study locations

1 site
  • Emine Aslan Telci
    Denizli, 20100, Turkey
08

References and documents

Publications

  • 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. PubMed 27634093 ↗
  • 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. PubMed 21430611 ↗
  • 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. PubMed 25202177 ↗
  • 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. PubMed 30526011 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04643756
Lead sponsor
Pamukkale University
Responsible party
Özgür Nadiye Karaman (Physiotherapist, MSc, Pamukkale University) — Principal investigator
First posted
Nov 25, 2020
Start date
Jan 1, 2020
Primary completion
Feb 1, 2021
Completion
Aug 1, 2021
Last update
Sep 13, 2021

Study contacts

Emine PT Aslan Telci, Prof. Dr
study director · Pamukkale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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