NCT03895307

Brief Summary

Low back pain can be seen in every period of life. More than 80 percent of the society complain of low back pain at any time of life. Although the frequency of applying to a health institution due to low back pain varies from one society to the other, it takes place in the first three places in each community. Low back pain should be differentiated as new (acute) and long-term (chronic). In the treatment of chronic low back pain, rest, education, pharmacological treatment, physical therapy, painful point injections, surgical interventions, kinesio taping can be applied. The most frequently used physical therapy modalities for treatment of chronic low back pain are superficial and deep heat modalities (hot pack, infrared, ultrasound, microwave diathermy radar) and analgesic effective electrotherapy (TENS, interferential flows) modalities. One of the most important treatments is exercise therapy. In cases where conventional treatment of chronic low back pain is insufficient, that is, the patient's pain is still ongoing and functional recovery is insufficient, some alternative methods are also applied. These treatments include ozone, prolotherapy injection applications, dry needling, acupuncture, phytotherapy, balneotherapy, kinesio taping and so on. The aim of this study is to compare the efficacy of painful point injection and kinesio taping treatments in lumbar region in patients with chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 28, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 2, 2020

Completed
Last Updated

April 13, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 28, 2019

Results QC Date

May 30, 2020

Last Update Submit

March 20, 2021

Conditions

Keywords

chronic low back painkinesio tapinginjectionlocal anesthetic

Outcome Measures

Primary Outcomes (4)

  • Pain Severity: Visual Analog Scale

    visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

    day 0 (before intervention)

  • Pain Severity: Visual Analog Scale

    visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

    day 16 (after 6th application)

  • Pain Severity: Visual Analog Scale

    visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

    1 month after intervention

  • Pain Severity: Visual Analog Scale

    visual analog scale: minimum score: 0 maximum score: 10. Higher scores reflect more severe pain

    3 months after intervention

Secondary Outcomes (16)

  • Disability Severity: Oswestry Disabiliy Index

    day 0 (before intervention)

  • Disability Severity: Oswestry Disability Index

    day 16 (after 6th application)

  • Disability Severity: Oswestry Disability Index

    1 month after intervention

  • Disability Severity: Oswestry Disability Index

    3 months after intervention

  • Patient Reported Quality of Life: Short Form 36 Physical Functioning

    day 0 (before intervention)

  • +11 more secondary outcomes

Study Arms (4)

kinesio taping

EXPERIMENTAL

two 15 cm I type kinesio tape applied longitudinally

Other: kinesio tape

sham kinesio taping

PLACEBO COMPARATOR

two 15 cm I type kinesio tape applied longitudinally but without stretching

Other: kinesio tape

local anesthetic

EXPERIMENTAL

18-20 cc %0.5 lidocaine subcutaneous injection

Other: local anesthetic

local serum physiologic

PLACEBO COMPARATOR

18-20 cc % 0.09 NaCl subcutaneous injection

Other: local serum physiologic

Interventions

two 15 cm I type kinesio tape applied longitudinally

kinesio tapingsham kinesio taping

local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection

local anesthetic

serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection

local serum physiologic

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Under 18 years of age under 75 years
  • Chronic mechanic (decreased with resting and resting) for at least 3 months
  • Visual Analogue Scale score of at least 60-

You may not qualify if:

  • Having mental problems
  • Having the disease affecting the peripheral and central nervous system
  • Have received physical therapy in the lumbar region within the last 3 months
  • Injection into the lumbar region within the last 3 months
  • Having a history of waist region surgery
  • Low motor dysfunction in lower extremity in physical examination
  • Needle phobia
  • Is allergic to lidocaine
  • Kinesio tape allergy
  • Wound, infection, burn, allergic lesions in the application area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sultan 2.Abdülhamid Han Training and Research Hospital

Istanbul, Eyalet/Yerleşke, 34000, Turkey (Türkiye)

Location

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Eyalet/Yerleşke, 34000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Athletic TapeAnesthetics, Local

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Results Point of Contact

Title
Adem Erbirol
Organization
SultanAbdulhamid

Study Officials

  • ADEM ERBİROL

    sultan abdulhamid han

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

March 29, 2019

Study Start

April 1, 2019

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

April 13, 2021

Results First Posted

July 2, 2020

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

other researchers would get information from the main researcher. therefore it was not shared.

Locations