NCT04170816

Brief Summary

We wiil evaluate the efficiency of adding kinesio taping (KT) therapy to dry needling (DN) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nCLBP).

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

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

September 15, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

September 15, 2019

Last Update Submit

November 18, 2019

Conditions

Keywords

Dry needlingKinesiotapeLow-back pain

Outcome Measures

Primary Outcomes (4)

  • Pain pressure threshold

    Amount of pressure (Kg/cm2) applied at the lomber multifidus muscle, quadratus lumborum and gluteus medius muscle myofascial trigger point site that elicit pain for the patient will be reported

    3 week

  • Pain by visual analog scale (VAS)

    Visual analog scale (VAS,0-10) will be used to assess resting, activity and night pain.

    3 week

  • Oswestry disability Index (ODI)

    Changes from the Baseline, ODI is an effective tool to provide information on the extent of backache affecting the patient ability to cope with tasks of everyday life. Ten sections are included in the ODI tool with a total possible score of 5 for each section. The first statement carries a score of 0, and the last has a score of 5.

    3 week

  • Beck Depression Inventory

    This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.

    3 week

Study Arms (2)

DN plus KT group

ACTIVE COMPARATOR

DN plus KT therapy is going to be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy is going to be applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles. Kinesio Taping Application: Tapes is going to be left on the patient's body for 5 days.

Device: Dry needling

DN group

ACTIVE COMPARATOR

DN will be applied 3 sessions in 1-week intervals. Dry Needling Theraphy: DN therapy was applied on active myofascial trigger points (MTrP) in quadratus lumborum, gluteus medius and lumbar multifidus muscles.

Device: Dry needling

Interventions

DN and KT therapy will be applied 3 sessions in 1-week intervals

Also known as: Kinesiotape
DN groupDN plus KT group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having no abnormal results in routine blood tests
  • having no known acute or chronic inflammatory disease
  • an education level required for understanding the applied treatment, interventions

You may not qualify if:

  • malignancies
  • active infection
  • history of common inflammatory rheumatic disease
  • trauma in spinal area, skin lesion, presence of infection or open wounds
  • radiculopathy
  • peripheral circulation disorder
  • use of warfarin due to coagulopathy
  • arthropathy
  • congenital or acquired spinal pathology
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry NeedlingAthletic Tape

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesBandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2019

First Posted

November 20, 2019

Study Start

December 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

November 20, 2019

Record last verified: 2019-11