NCT06961903

Brief Summary

This study aimed to compare the effects of functional taping, manual therapy, and stereodynamic interference current applications on pain, functional capacity, sleep quality, and kinesiophobia in individuals with chronic low back pain (LBP). Conducted with 88 participants, the study divided them into four groups: a control group (standard physiotherapy), a functional taping group, a manual therapy group, and a stereodynamic interference current group. All groups received 10 sessions of treatment, 3 days a week. The study evaluated pain intensity (VAS), fear of movement (FOM), functional disability (ODI), and sleep quality (PSQI) at three points: before treatment, after treatment, and one month later. Results showed that manual therapy significantly improved pain levels (p\<0.05), while stereodynamic interference current also reduced pain. Functional taping was most effective in reducing kinesiophobia (p\<0.05). No significant differences were observed between the groups in terms of the Oswestry Disability Index and Pittsburgh Sleep Quality Index scores (p\>0.05). The study concluded that manual therapy was the most effective for pain control, and functional taping was superior for managing kinesiophobia, emphasizing the need for individualized and multidisciplinary approaches in treating musculoskeletal health issues.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
Last Updated

May 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 29, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

Chronic low back painmanual therapyfunctional tapingelectrotherapykinesiophobia

Outcome Measures

Primary Outcomes (4)

  • pain intensity

    The VAS is a measurement tool that allows individuals to subjectively assess the intensity of pain they perceive. The VAS is usually located on a 10 cm long horizontal line between two extremes ranging from 'no pain' to 'unbearable pain'. Participants are asked to mark their current pain level on this line and the measurement is made by evaluating the distance from the marked point to the starting point in centimetres (cm). The VAS is a simple and reliable tool that is frequently preferred to quantitatively measure the severity of pain, especially in clinical research.

    through study completion, an average of one month.

  • kinesiophobia level

    The Tampa Kinesiophobia Scale (TSK) is a self-report form developed to measure the fear of movement that individuals develop due to pain. The TSK consists of a total of 17 items and each item is scored from 'strongly disagree' to 'strongly agree' on a 4-point Likert-type scale. High scores indicate a high level of movement avoidance and pain-related fear of movement. Especially in individuals with chronic pain, it is an important tool in terms of evaluating the fear of movement related to pain and making plans for treatment.

    through study completion, an average of one month.

  • Low Back Disability Index

    The Oswestry Low Back Disability Index (ODI) is a comprehensive scale developed to assess the level of functional disability in individuals with low back pain and measures the impact of low back pain on activities of daily living. This index, which consists of a total of 10 items, evaluates daily activities such as pain intensity, personal care, lifting, walking, sitting, sitting, standing, sleeping, social life, travelling and sex life. Each item is scored between 0 and 5 and the level of disability is determined by converting the total score into a percentage. Higher scores mean more disability. The ODI is one of the most widely used tools worldwide to measure functional status in individuals with chronic low back pain.

    through study completion, an average of one month.

  • Sleep Quality Index

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report scale developed to assess the sleep quality of individuals in the last month. The PSQI consists of a total of 19 items and assesses seven different components, including sleep duration, sleep latency, sleep efficiency, sleep disturbances, sleep medication use, and daytime sleepiness. The scores obtained from each component are included in the total scoring to determine the overall sleep quality. The total score obtained varies between 0 and 21; high scores indicate poor sleep quality. PSQI is a reliable measurement tool to detect sleep quality deterioration especially in chronic pain patients.

    through study completion, an average of one month.

Study Arms (4)

physiotherapy

EXPERIMENTAL

A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.

Other: physiotherapy programme

Functional Taping

EXPERIMENTAL

A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. In addition, the taping method applied in this study can be defined as a "Function-Oriented Taping Application to Preserve Extension: Lumbar Extension Taping," which was specifically designed to maintain lumbar extension.

Other: physiotherapy programmeOther: Functional Taping

Manual Therapy

EXPERIMENTAL

A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.Manual Therapy (MT), which literally means "hands-on treatment," is an evidence-based therapeutic approach consisting of skilled hand movements and maneuvers applied to produce therapeutic effects and to treat musculoskeletal dysfunctions and pain. In addition to the standard program, manual therapy was also administered in this study.

Other: physiotherapy programmeOther: Manual Therapy

Stereodynamic Interference Current

EXPERIMENTAL

A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.In addition, the stereodynamic interference current method was applied in this study. A 'Y' electrode was used during the application. Due to the rapid development of accommodation, the current intensity was frequently increased during the session. The average treatment duration was 15 minutes, and a frequency of 50-100 Hz was used to achieve analgesic effects.

Other: physiotherapy programmeOther: Stereodynamic Interference Current

Interventions

A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.

Functional TapingManual TherapyStereodynamic Interference Currentphysiotherapy

A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention. In addition, the taping method applied in this study can be defined as a "Function-Oriented Taping Application to Preserve Extension: Lumbar Extension Taping," which was specifically designed to maintain lumbar extension.

Functional Taping

A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.Manual Therapy (MT), which literally means "hands-on treatment," is an evidence-based therapeutic approach consisting of skilled hand movements and maneuvers applied to produce therapeutic effects and to treat musculoskeletal dysfunctions and pain. In addition to the standard program, manual therapy was also administered in this study.

Manual Therapy

A program consisting of therapeutic ultrasound, hot pack, massage, and McKenzie exercises was administered as the intervention.In addition, the stereodynamic interference current method was applied in this study. A 'Y' electrode was used during the application. Due to the rapid development of accommodation, the current intensity was frequently increased during the session. The average treatment duration was 15 minutes, and a frequency of 50-100 Hz was used to achieve analgesic effects.

Stereodynamic Interference Current

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • participants had to be aged between 20 and 50 years,
  • have a diagnosis of chronic low back pain (low back pain persisting for more than 12 weeks),
  • have a Visual Analogue Scale (VAS) score of at least 4/10,
  • be suitable for physical therapy, and sign a written informed consent form by voluntarily agreeing to participate in the study.

You may not qualify if:

  • with a history of lumbar surgery,
  • acute inflammatory diseases or signs of infection, rheumatological, neurological or cardiovascular system diseases,
  • pregnancy status,
  • history of invasive intervention in the lumbar region within the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

acibadem Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study was conducted with single-blind masking, where the participants were blinded to the group allocation. Participants were not informed about the specific physiotherapy technique or intervention they received (e.g., whether they received functional taping, manual therapy, or stereodynamic interference current) to minimize expectation bias. However, due to the nature of the interventions, therapists administering the treatment were not blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 8, 2025

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 31, 2023

Last Updated

May 8, 2025

Record last verified: 2025-04

Locations