NCT06952205

Brief Summary

Purpose of this study is to determine the efficiency of functional tape application to patients with acute or subacute low back pain. 40 patients with acute-subacute low back pain were divided into two groups: control and experimental group. To control group, McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied. To experimental group, functional taping were applied in addition of these treatments. Range of Motion (ROM), Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia (TSK) and The Oswestry Disability Index (ODI) were evaluated preand post-treatment and datas were analyzed with statistical methods. In analysis; p value was accepted p\<0,05 for t test and Mann Whitney U test process. In the measurements that compared the improvement of both groups, based on pre- and post-treatment evaluations; improvement in the experimental group was significantly higher in all of these parameters of ROM, VAS, TSK and ODI than in the control group (p\<0,05). The use of functional rigid taping in patients with acute and subacute low back pain provided a statistically significant improvement in all measured values of patients and provide better results than the control group. However, there is a need for comparative new studies in order to measure the effectiveness of rigid taping in a more accurate way.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2017

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 17, 2025

Last Update Submit

April 28, 2025

Conditions

Keywords

Rigid tapingFunctional taping

Outcome Measures

Primary Outcomes (4)

  • Range of Motion

    The flexion, extension, rotation, and lateral flexion range of motion of the lumbar region will be measured using a goniometer

    through study completion, an average of 2 weeks.

  • Pain intensity

    The Visual Analog Scale (VAS) will evaluate low back pain by asking participants to mark their pain level on a 10 cm scale, where 0 indicates no pain and 10 indicates severe pain, based on their experience over the past week.

    through study completion, an average of 2 weeks.

  • Degree of kinesiophobia

    The Tampa Kinesiophobia Scale measures an individual's level of fear related to movement. Participants complete a 17-item questionnaire, indicating their fear and anxiety levels towards specific physical activities or movements. The scale uses a scoring system from 1 to 4 for each item, with a total score of up to 68. Higher scores indicate a higher level of kinesiophobia, while lower scores indicate less fear.

    through study completion, an average of 2 weeks

  • Disability Index

    The Oswestry Disability Index (ODI) measures functional limitations in daily activities due to low back pain. The questionnaire consists of 10 sections, each assessing difficulties experienced by the participant due to pain. Participants rate each section from 0 to 5. The total score indicates the level of disability, with higher scores reflecting greater limitations in the individual's quality of life.

    through study completion, an average of 2 weeks

Study Arms (2)

functional taping

EXPERIMENTAL

McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied.To experimental group, functional taping were applied in addition of these treatments.

Other: Experimental groupOther: only exercises

control group with only exercises

ACTIVE COMPARATOR

McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments

Other: only exercises

Interventions

McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments were applied.To experimental group, functional taping were applied in addition of these treatments.

functional taping

McKenzie exercises, Transcutaneous Electrical Nerve Stimulation (TENS), Hot Pack (HP) and pulsed ultrasound treatments

control group with only exercisesfunctional taping

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 20 and 65
  • Being literate in Turkish
  • Having lower back pain for less than 3 months
  • Informed Consent Form for taping application to have been signed

You may not qualify if:

  • Allergic reaction on the skin
  • Hypertension, Type 2 diabetes mellitus (DM) and Presence of accompanying systemic disease other than hypercholesterolemia
  • Not being able to communicate
  • Using corsets and similar supports
  • Having a body mass index \> 30
  • Use of antidepressant and myorelexan medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar Üniversity Physiotherapy and Rehabilitation Department

Istanbul, Ümraniye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainKinesiophobia

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 17, 2025

First Posted

April 30, 2025

Study Start

February 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 23, 2017

Last Updated

April 30, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations