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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06212011
Other study ID # 204574
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date March 15, 2025

Study information

Verified date February 2024
Source Hacettepe University
Contact Duygu Yilmaz, PT, M.Sc.
Phone +905547936726
Email duygu.dylmz@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomized controlled trial, is to investigate the effect of superimposed 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 superimposed 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date March 15, 2025
Est. primary completion date January 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - History of chronic low back pain (12 weeks<) - Pain in the lumbar and/or hip area (VAS>3) - Volunteering to participate in the study Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Superimposed Neuromuscular Electrical Stimulation
The superimposed technique involves the application of electrical stimulation during voluntary muscle contraction. In our study, in the superimposed 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.
Conventional Neuromuscular Electrical Stimulation
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Hip and Lumbar spine range of motion Hip and Lumbar spine range of motion will be evaluated using goniometer and recorded in degrees. Baseline and first week after 8-week intervention
Secondary Shortness of the hip flexor, knee flexor and plantar flexor muscles Shortness of the hip flexor, knee flexor and plantar flexor muscles will be evaluated by Thomas test, popliteal angle hamstring test and ankle dorsiflexion ROM measurements, respectively. Results will be recorded in degrees. Baseline and first week after 8-week intervention
Secondary Beighton test The Beighton test is a screening technique for hypermobility. The test is a nine-point scale and requires the performance of 5 maneuvers. Baseline and first week after 8-week intervention
Secondary Visual analogue scale Visual analog scale will be used to evaluate pain. The visual analog scale consists of a single 10 cm line used to evaluate pain intensity. Patients will be asked to mark the severity of their pain at rest, during activity and during night. Baseline and first week after 8-week intervention
Secondary Oswestry Disability Index Oswestry Disability Index will be used to evaluate the degree of loss of function. Higher values represent greater disability. Baseline and first week after 8-week intervention
Secondary Roland-Morris Disability Questionnaire Roland-Morris Disability Questionnaire will be used to evaluate functional disabilities. Higher values represent greater disability. Baseline and first week after 8-week intervention
Secondary Tampa Kinesiophobia Scale Tampa Kinesiophobia Scale will be used to evaluate fear of movement/reinjury. Higher values represent greater kinesiophobia. Baseline and first week after 8-week intervention
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