NCT06875180

Brief Summary

The aim of this study was to investigate the effect of telerehabilitation on pain, disability, kinesiophobia and normal range of motion in patients with chronic non-specific low back pain. The study included 100 patients aged 18-64 years with chronic non-specific low back pain. In our study, McKenzie extension exercises were applied to 50 patients online via the zoom platform and to 50 patients face-to-face in the clinical environment under the supervision of a physiotherapist in charge. In our study, pain was assessed with the VAS, disability was assessed with the ODI, kinesiophobia was assessed with the TKS, and ROM was assessed with a goniometer. As a result of our study, there was no statistically significant difference in VAS values between both groups, a statistically significant difference was observed in both groups according to the measurement times and the pain level decreased in both groups. As a result of our study, there was no statistically significant difference in ODI values between both groups, a statistically significant difference was observed in both groups according to the measurement times and the level of disability decreased in both groups. As a result of our study, there was no statistically significant difference between the two groups in TKS values and no difference was observed according to the measurement times in both groups. As a result of our study, there was no statistically significant difference in ROM values between both groups, a statistically significant difference was observed in both groups according to the measurement times and ROM values increased. In conclusion, telerehabilitation in patients with chronic non-specific low back pain is as effective as face-to-face exercise training in improving pain, disability and range of motion levels, but the effect of telerehabilitation on improving kinesiophobia has not been found.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

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

December 10, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

January 29, 2025

Last Update Submit

August 2, 2025

Conditions

Keywords

Chronic non-specific low back paintelerehabilitationMcKenziedisabilitykinesiophobiapainrange of motion

Outcome Measures

Primary Outcomes (3)

  • Disability

    In our study, disability has assessed with the Oswestry Disability Index (ODI).

    18 months

  • Pain intensity

    In our study, pain has assessed with the Visual Analogue Scale (VAS). Scores range from 0 to 10

    18 months

  • Kinesiophobia

    In our study, kinesiophobia has assessed with the Tampa Kinesiophobia Scale (TKS). Scores range from 17 to 68 points.

    18 months

Secondary Outcomes (1)

  • Range of motion

    18 months

Study Arms (2)

Tele-rehabilitation group

EXPERIMENTAL

Tele-rehabilitation exercise was applied to this group.

Other: Tele-rehabilitation exercise

Face-to-face group

ACTIVE COMPARATOR

This group underwent conventional face-to-face exercise.

Other: Face-to-face exercise

Interventions

For this group, McKenzie extension exercises were applied to 50 patients online via the zoom platform.

Tele-rehabilitation group

For this group, 50 patients face-to-face in the clinical environment under the supervision of a physiotherapist in charge.

Face-to-face group

Eligibility Criteria

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

You may qualify if:

  • Being between 18-64 years of age,
  • Having non-specific low back pain for ≥3 months,
  • Not having radicular symptoms related to low back pain

You may not qualify if:

  • History of surgery on the spine and/or extremities,
  • Diagnosis of malignancy,
  • Orthopaedic and neurological disorders affecting the evaluation and treatment, - Psychiatric illness,
  • Physical therapy for low back pain in the last six months,
  • Being pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko University

Gaziantep, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KinesiophobiaPain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arzu Demirguc, PhD, Professor

    Sanko University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pınar Kuyulu Haksal, PhD(c)

Study Record Dates

First Submitted

January 29, 2025

First Posted

March 13, 2025

Study Start

December 10, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

August 5, 2025

Record last verified: 2025-08

Locations