Dry Needling With And Without Kinesio Taping® in The Non-Specific Chronic Low Back Pain

Comparing Dry Needling With And Without Kinesio Taping® in The Treatment of Non-Specific Chronic Low Back Pain

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).

Study Overview

• Status: Unknown
• Conditions: Non-Spesific Chronic Low Back Pain
• Intervention / Treatment: Device: Dry needling

Detailed Description

A total of 60 patients will be included in the study. 30 patients will be in the treatment group and 30 patients will be in the control group. Both groups will be underwent 3 sessions with 1-week intervals on active myofascial trigger points in lumbar multifidus, quadratus lumborum and gluteus medius muscles in DN therapy. KT application will be performed after every DN session in the study group. Pain will evaluate with visual analog scale, functionality was evaluated with Oswestry Disability Index and the status of depression will be evaluated with Beck Depression Index before the treatment and at the first month.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DN plus KT group; 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 and KT therapy will be applied 3 sessions in 1-week intervals; Other Names: Kinesiotape
Active Comparator: DN group; 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; DN and KT therapy will be applied 3 sessions in 1-week intervals; Other Names: Kinesiotape

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kars State Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Dry needling; Kinesiotape; Low-back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 80576354-050-99/167

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No