NCT04776798

Brief Summary

It is stated that abnormal lower extremity posture and biomechanics are effective in the development and progression of Low Back Pain (LBP). Exercise, electrotherapy, insoles, and orthoses are used for the prevention and treatment of low back pain.The use of orthosis, insoles, and taping techniques stands out in the correction of foot posture and dysfunctions, which are stated to cause LBP. In studies examining the application of taping to improve foot posture and biomechanics, it is stated that taping is effective in improving foot posture and biomechanics in the short term. Biomechanical taping has been used in the treatment of musculoskeletal disorders in recent years. It is aimed to correct the impaired joint biomechanics by reducing the load on the joint, supporting strength, and providing movement modification.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

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

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 27, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

February 27, 2021

Last Update Submit

August 3, 2022

Conditions

Keywords

biomechanical-tapingmechanical low back painfoot posturefunction

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale (VAS)

    It is used to evaluate the level of pain.The activity, rest and night pain levels of the patients will be question.

    4 week

  • Foot Posture Index (FPI-6)

    FPI-6 examines foot posture under 6 headings: talar head palpation, supra and infra lateral malleoli curvature, calcaneal frontal plane position, prominence in region of talonavicular joint, congruence of medial longitudinal arch, abduction/adduction of forefoot on rearfoot. Each measure is scored from -2 to 2. A total score of 0 is considered a neutral foot; a positive score is for pronated foot, whereas a supinated foot is given a negative score.

    4 week

Secondary Outcomes (4)

  • 6 Minute Walk Test (6MWT)

    4 week

  • Step-On-Stool Test

    4 week

  • PILE Lumbar Lifting Test

    4 week

  • Revised Oswestry Disability Index

    4 week

Study Arms (2)

Biomechanical Taping

EXPERIMENTAL

Anti pronation taping will apply bilaterally with Dynamic Tape®. The tape will attach to the dorsal aspect of the foot. A home-based exercise program will apply in the first session. Printouts showing the exercises will give to the patients. Exercises will be done at home for 4 weeks, 5 d/w.

Other: Taping

Placebo Taping

PLACEBO COMPARATOR

Placebo Taping will apply bilaterally to each individual in the control group by the same physiotherapist, without any effect on increased pronation. A home-based exercise program will apply in the first session. Printouts showing the exercises will give to the patients. Exercises will be done at home for 4 weeks, 5 d/w.

Other: Taping

Interventions

TapingOTHER

Tape applications will repeat twice per week, for 4 weeks.

Biomechanical TapingPlacebo Taping

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanical low back pain for at least 6 months
  • Age between 18-65 years
  • Increased, bilateral, flexible pronation of the feet (Foot Posture Index-6 score\> 0)

You may not qualify if:

  • Rigid pes planus, pes cavus, equinus deformity, hallux valgus, hallux rigid or calcaneal epin in the feet
  • Lower extremity injury or surgery in the last 6 months
  • Radicular type back pain (patients with leg pain\> low back pain)
  • Body Mass Index (BMI)\> 30,
  • Use of analgesics
  • Pregnancy
  • Presence of symptoms related to a history of spinal surgery in the last 5 years.
  • Neurological impairment or cognitive dysfunction (stroke, dementia, etc.)
  • Rheumatological diseases
  • Peripheral vascular diseases
  • Difference in length between extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Alpözgen

Küçükçekmece, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayse Zengin Alpozgen, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 2, 2021

Study Start

March 1, 2021

Primary Completion

November 1, 2022

Study Completion

February 1, 2023

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations