NCT06212011

Brief Summary

The goal of this randomized controlled trial, is to investigate the effect of functional NMES and conventional NMES applied to the lumbar multifidus muscle on body kinematic and kinetic values during the sit-to-stand in individuals with non-specific low back pain. Our study will include 24 participants between the ages of 18-65. Which physiotherapy intervention will be applied to the participants will be determined by the block randomization method, using a table of random numbers. After randomization; NMES to the participants' lumbar multifidus muscle during physiotherapy intervention will be applied in two groups; In the first group, NMES will be applied with the conventional technique during prone position and in the second group, NMES will be applied with the functional technique during the sit-to-stand activity. Evaluations will be made twice for each participant- before and after the intervention. During the evaluation, data regarding the change in body kinetics and kinematics of individuals during the sit-to-stand activity will be recorded with a Vicon camera system. For secondary outcome measures, a visual analog scale will be used to evaluate pain, the Roland Morris Disability Questionnaire and the Oswestry Disability Index will be used to evaluate functional status, and the Tampa Kinesiophobia Scale will be used to evaluate fear-avoidance behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2024

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

July 2, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

December 24, 2023

Last Update Submit

June 28, 2025

Conditions

Keywords

low back painelectric stimulationsit to standkinetickinematic

Outcome Measures

Primary Outcomes (2)

  • Changes in kinematics of the Lumbar Spine and Hip During sit-to-stand activity

    With kinematic analysis, the mean, minimum and maximum range of motion of the lumbar spine and hip joint during the sit-to-stand activity will be evaluated and recorded in degrees using the vicon motion capture system (Vicon, 6xVantage 5 Cameras 5MP@420FPS, 2xVue Video Cameras).

    Baseline and first week after 8-week intervention

  • Changes in ground reaction force during sit-to-stand activity

    Ground reaction force will be evaluated using force plates (2xAMTI force plates).

    Baseline and first week after 8-week intervention

Secondary Outcomes (7)

  • Hip and Lumbar spine range of motion

    Baseline and first week after 8-week intervention

  • Shortness of the hip flexor, knee flexor and plantar flexor muscles

    Baseline and first week after 8-week intervention

  • Beighton test

    Baseline and first week after 8-week intervention

  • Visual analogue scale

    Baseline and first week after 8-week intervention

  • Oswestry Disability Index

    Baseline and first week after 8-week intervention

  • +2 more secondary outcomes

Study Arms (2)

Functional Neuromuscular Electrical Stimulation Group

EXPERIMENTAL

Functional NMES involves stimulating the lumbar multifidus muscle while the individual performs a sit-to-stand activity.

Other: Functional Neuromuscular Electrical Stimulation

Conventional Neuromuscular Electrical Stimulation Group

EXPERIMENTAL

Conventional NMES intervention involves only stimulating the lumbar multifidus muscle while the individual is in the prone position, and the individual will not reveal any voluntary contraction during stimulation.

Other: Conventional Neuromuscular Electrical Stimulation

Interventions

The functional NMES technique involves the application of electrical stimulation during functional activity. In our study, in the functional neuromuscular electrical simulation group, neuromuscular electrical stimulation will be applied to the lumbar multifidus muscle while individuals perform the activity of standing up from sitting.

Functional Neuromuscular Electrical Stimulation Group

The conventional neuromuscular electrical simulation technique, electrical stimulation is applied without the individual performing voluntary contractions. In our study, conventional NMES will be applied to the lumbar multifidus muscle with the individual lying in the prone position and the individual will not elicit any voluntary contractions during the simulation.

Conventional Neuromuscular Electrical Stimulation Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of chronic low back pain (12 weeks\<)
  • Pain in the lumbar and/or hip area (VAS\>3)
  • Volunteering to participate in the study

You may not qualify if:

  • History of neurological, metabolic, cardiovascular disease
  • Having had spinal surgery, specific lumbar pathology, scoliosis, pregnancy, history of systemic or degenerative disease
  • Musculoskeletal system pathology in the last year
  • Body mass index being over 30 kg/m2
  • Continuing any exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 24, 2023

First Posted

January 18, 2024

Study Start

May 1, 2024

Primary Completion

June 10, 2025

Study Completion

June 15, 2025

Last Updated

July 2, 2025

Record last verified: 2025-04

Locations