NCT05940519

Brief Summary

Previous evidence has shown that kinesio tape application reduces pain levels and improves disability in patients with chronic low back pain due to lumbar disc herniation. However, it is not known, whether the dynamic taping can decrease back pain, improve endurance of paraspinal muscles, and improve functional capacity in patients with lumbar disk herniation. The aim of the current study is to examine the acute effects of dynamic taping on pain, pain threshold, endurance, balance, lumbar joint mobility and functionality in patients with lumbar disc herniation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 12, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

June 29, 2023

Last Update Submit

July 11, 2023

Conditions

Keywords

lumbar disc herniationdynamic tapeacute pain

Outcome Measures

Primary Outcomes (2)

  • Pain severity evaluation

    The severity of the pain will be measured with Numerical Rating Scale. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

    Up to one month

  • Pain threshold measurement

    Pain threshold will be measured Jtech Commander digital algometer

    Up to one month

Secondary Outcomes (4)

  • The evaluation of lumbar muscle endurance

    Up to one month

  • The evaluation of balance

    Up to one month

  • Lumbar joint mobility

    Up to one month

  • Functional movement level

    Up to one month

Study Arms (2)

dynamic tape group

EXPERIMENTAL

The dynamic tape group

Other: Dynamic taping techniqueOther: Sham taping

sham taping group

SHAM COMPARATOR

The sham tape group

Other: Dynamic taping techniqueOther: Sham taping

Interventions

The dynamic taping method as specified in the literature will be applied to the right and left lumbar paravertebral muscles in the dynamic taping group. Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.

dynamic tape groupsham taping group

Sham taping will be applied with a surgical patch while the patient is in a comfortable position without any technique or stretching.Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. Patients' pain will be evaluated with Numerical Rating Scale, pain threshold Jtech Commander digital algometer, lumbar muscle endurance Modified Sorenson Test, balance functional reach test, lumbar joint mobility universal goniometer and functional movement levels of patients with timed get up and go test. Evaluations will be carried out in 3 stages: before taping, 2 hours after taping and 3 days after taping. The measurements of the dynamic and sham taping applications of the 2 hours after and 3 days will be compared with the pre-taping and post taping results between two groups.

dynamic tape groupsham taping group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with diagnose of lumbar disc herniation,
  • self-reported activity pain due to lumbar disc herniation for at least the last 3 months,
  • with pain severity equal to or greater than 3 on a numerical rating scale,
  • patients with no skin irritation, sensitivities or allergies

You may not qualify if:

  • Patients with spinal pathology, lumbar surgery, motor weakness, urinary or fecal incontinence due to lumbar disc herniation, cauda equina syndrome, pregnancy, neurological or rheumatological condition, dermatitis or pre-existing skin lesion over the taping area, and having dynamic taping allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc DisplacementAcute Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

M.Fatih Adalı, Msc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will not informed about the intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor,advisor

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 11, 2023

Study Start

July 12, 2023

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07