NCT06417255

Brief Summary

Low back pain is an important health problem that is common worldwide, with a lifetime prevalence of up to 80%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

May 11, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

May 11, 2024

Last Update Submit

January 28, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Pressure Pain Measurement with Algometer

    The algometer, an effective way of measuring pressure pain threshold (PPT), is used to measure soft tissue pain associated with trigger points. Pittsburgh Sleep Quality Scale The Pittsburgh Sleep Quality Index is the most commonly used general measure in clinical and research settings to assess sleep quality and quantity. The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 19 questions and 7 components to assess sleep quality during the last month. The total score had a value between 0-21 Schober Flexibility Test With the patient standing, the examiner marks the spinous process of the first sacral vertebra and 10 cm above this point. The patient is then asked to flex forwards as if trying to touch their toes while keeping their knees straight. If the distance between the two points does not increase by at least 5 cm, this is considered a sign of restriction in lumbar flexion.

    6 weeks

  • Pittsburgh Sleep Quality Scale

    The Pittsburgh Sleep Quality Index is the most commonly used general measure in clinical and research settings to assess sleep quality and quantity. The Pittsburgh Sleep Quality Index (PSQI) consists of a total of 19 questions and 7 components to assess sleep quality during the last month. The total score had a value between 0-21

    6 weeks

  • Schober Flexibility Test

    With the patient standing, the examiner marks the spinous process of the first sacral vertebra and 10 cm above this point. The patient is then asked to flex forwards as if trying to touch their toes while keeping their knees straight. If the distance between the two points does not increase by at least 5 cm, this is considered a sign of restriction in lumbar flexion.

    6 weeks

  • The finger-to-floor distance

    The finger-to-floor distance test is a test that measures specific physical disability. This test is performed with the person standing upright with feet together. The patient is asked to lean as far forward as possible with knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the floor is measured with a flexible tape measure.

    6 weeks

  • Tampa Kinesiophobia Fatigue Scale

    The Tampa Kinesiophobia Scale measures fear of movement and fear of (re)injury during movement. High fear of movement and/or (re)injury, as measured by the Tampa Kinesiophobia Scale, has been found to be associated with poor performance on a number of physical tests. The minimum and maximum values of the Tampa Kinesiophobia Fatigue Scale are between 17 and 68. The total score range of this scale is between 0 and 68.

    6 weeks

  • Oswestry Scale

    The Oswestry Disability Index, first introduced by Fairbank et al. in 1980, is considered close to the gold standard for measuring the severity of disability due to low back pain. The Oswestry scale is a self-administered, free, easy-to-use and easy-to-score questionnaire containing 10 questions on different functional domains. The Oswestry Disability Index (ODI) is a widely used tool to assess disability related to low back pain. It consists of 10 sections addressing various daily activities, each scored on a scale of 0 to 5. The minimum score is 0, indicating no disability, while the maximum score is 50, indicating severe disability.

    6 weeks

Study Arms (2)

kinesiotape application

EXPERIMENTAL
Other: kinesiotape application

foam roller application

ACTIVE COMPARATOR
Other: foam roller application

Interventions

The strips used for kinesiological taping can be applied by giving different shapes. These shapes are I, Y, X, ring (donut), rake and net

kinesiotape application

In the foam roller group, "Actifoam" brand non-serrated foam rollers with a size of "15x90" cm were used.

foam roller application

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with chronic low back pain
  • Individuals aged 18-60 years
  • Patients without verbal communication barriers
  • Patients without cognitive impairment (delirium, dementia, amnesia)

You may not qualify if:

  • Exercise contraindication (uncontrolled medical conditions)
  • Patients with previous spinal surgery
  • Patients who develop an allergic reaction to the kinesiotape tape to be applied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hazal GENÇ

Istanbul, None Selected, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

May 11, 2024

First Posted

May 16, 2024

Study Start

May 11, 2024

Primary Completion

July 26, 2024

Study Completion

September 21, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations