NCT05319184

Brief Summary

Chronic low back pain (LBP) is one of the leading causes of activity limitation and disability. The prevalence of chronic CBA among young adults is known to increase, and a recent epidemiological study reported a rate of 42.4% per year among young adults. Studies show that changes in the paravertebral muscles have an important relationship with the formation of Chronic LBP, and therefore, evaluation of the mechanical properties of the paravertebral muscles is of great importance for the clinical diagnosis and treatment of Chronic LBP. Mechanical properties of the muscle, such as muscle stiffness and tone, are considered essential for maintaining efficient muscle contraction. Abnormally high muscle tone blocks blood flow, leading to faster muscle fatigue and slower muscle recovery. When there is abnormally high muscle stiffness, stretching the stiffened antagonist muscles requires more effort, resulting in lower exercise efficiency. Muscle stiffness is one of the critical indicators of energy storage of the muscle-tendon unit, which has a significant effect on the control of joint movement. Altered tone and stiffness in the lumbar myofascial region have been described in association with underlying pathologies and symptoms in people with Chronic LBP. Rehabilitation interventions such as manual therapy or therapeutic exercises are common techniques for the treatment of chronic Chronic LBP because of their benefits in altering muscle tone and stiffness by reducing paraspinal muscle activity. Although the effectiveness of the myofascial release technique in individuals with Chronic LBP is supported in the literature, the long-term use of the therapist's hand support creates difficulties in practice in the clinical setting. The KT technique, on the other hand, seems to be a method that can be used as an alternative to myofascial release technique in the treatment of Chronic LBP, since it is an easy-to-use and time-consuming approach. When the studies conducted to date are examined, no study has been found that compares the effectiveness of myofascial release and kinesiology taping applied to individuals with Chronic LBP. The aim of our study is to compare the acute effect of myofascial release and kinesiology taping in individuals with Chronic LBP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

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 31, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

March 31, 2022

Last Update Submit

September 18, 2023

Conditions

Keywords

Low Back PainKinesio TapingMyofascial release technique

Outcome Measures

Primary Outcomes (3)

  • Muscle Tone and Stiffness

    Muscle tone and stiffness will be evaluated with a myotonometer. The myotonusometer was developed for the objective measurement of mechanical muscle properties. Myotonusometry reflects the viscoelastic properties of the muscle such as tone and stiffness by creating oscillation in the muscle fiber and is an acceptable and reliable method for measuring the mechanical properties of the muscle in young adults with chronic LBP. The device measures muscle tone as the natural oscillation frequency (Hz) calculated as Hz = 1/T; where T is the oscillation time measured in seconds. Muscle stiffness (N/m) is related to the maximum acceleration of oscillation and tissue deformation recorded by the transducer.

    4 weeks

  • Visual Analogue Scale

    The Visual Analog Scale is a simple, precise and reproducible tool that is often used to assess pain severity. Due to its easy application, it is one of the most frequently used measurement tools to measure the severity of pain in low back pain. It consists of a horizontal or vertical line ten cm long. The starting point of the line, '0', represents no pain, and the ending point, '10', represents the most severe pain imaginable. Pain intensity increases as you go from 0 to 10. The patient is asked to mark the severity of the pain on the line, the point marked by the patient is recorded in cm.

    4 weeks

  • Joint Range of Motion

    Lumbar region flexion, extension, lateral flexion and rotation movements will be measured bilaterally with a digital goniometer. Measurements will be repeated 3 times and the average value will be recorded in degrees.

    4 weeks

Secondary Outcomes (3)

  • Mobility

    4 weeks

  • Progressive İsoinartial Lifting Evaluation

    4 weeks

  • 1 Minute Stepping Test

    4 weeks

Study Arms (3)

Myofascial Release Group

EXPERIMENTAL

The application will be made with the patient in the prone position. By applying a few grams of constant force to the lumbar paravertebral muscles bilaterally with the hand of the physiotherapist in the direction of restriction for 3-5 minutes, the fascia will be stretched and allow the tissue to relax on its own. Thus, it is aimed to decrease the tone and stiffness of the paravertebral muscles.

Other: Myofascial Release Technique and Kinesiology Taping

Kinesiology Taping Group

EXPERIMENTAL

During the application, the participants will be positioned standing and facing backwards due to the ease of application. While taping the lumbar region, the kinesiology tape cut as a long strip (I tape) will be applied paravertebrally to the right and left sides of the spine. Rounded corners will be created to prevent premature loosening and unwanted bends in the belt. The patient will be asked to perform maximum trunk flexion and 2 I-shaped pieces will be taped with 10-15% tension from the lumbar region to the thoracic region. The tape will remain on the patient's skin for 30 minutes.

Other: Myofascial Release Technique and Kinesiology Taping

Control Group

NO INTERVENTION

No intervention.

Interventions

Myofascial release is a manual release technique that increases the elasticity and glide between soft tissue layers, reduces this increased muscle activity and pain intensity. Myofascial release is usually characterized by prolonged mechanical forces exerted directly or indirectly on the limited fascial layers with low load. Following the direction of the fascial restraint, the therapist's hands slowly maintain the stretch and allow the fascia to relax on its own. Kinesio Taping is a non-invasive, painless and less time consuming method with fewer side effects. It is an elastic-cotton adhesive tape that is latex-free and can be used on any joint or muscle. It can stretch significantly (130-140% of its original length), which reduces mechanical movement limitations and mimics skin in thickness and elasticity. It is used in the treatment of LBP to reduce muscle tone and stiffness as a rehabilitative taping technique designed to support the body's natural healing process.

Kinesiology Taping GroupMyofascial Release Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-45
  • Being diagnosed with nonspecific chronic low back pain (lasting longer than 3 months)
  • Volunteering to participate in the study

You may not qualify if:

  • Those who have had major surgery or trauma related to the musculoskeletal system, especially the lumbar region
  • Those with neurological disease
  • Those with rheumatic disease in the active period
  • Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
  • Those with serious psychological problems (BDI score of 30 and above)
  • Those with kinesiology tape allergies
  • Those with contraindications to myofascial release therapy (acute inflammations, viral and bacterial infections, infectious diseases, fever, deep vein thrombosis, active malignant disease, aneurysms)
  • Those who received physiotherapeutic intervention to the lumbar region in the last 6 months
  • Obesity (BMI≥30 kg/m2)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul university Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 8, 2022

Study Start

June 30, 2023

Primary Completion

September 1, 2023

Study Completion

September 15, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations