NCT06227767

Brief Summary

Chronic low back pain, which individuals have difficulty coping with in the modern age and is one of the most common reasons for applying to health institutions, has important consequences for individuals and society. Approximately 80% of individuals experience low back pain throughout their lives, and 10-20% become chronic. Low back pain causes varying degrees of restrictions in individuals' daily living activities, modification or reduction of movements due to pain. This situation causes the pain to continue and causes the functional level to decrease in individuals with low back pain. There are many approaches to the treatment of chronic low back pain, and among these, exercise treatments have been shown to be effective in reducing pain and improving functionality. Spinal stabilization exercises, which have an important place among current exercise approaches for chronic low back pain, ensure the formation of a neutral position in the spine by activating the core muscles consisting of multifidus, transversus abdominis, diaphragm and pelvic floor muscles. Perception of neutral position is provided and applied in daily living activities. In this way, pain is reduced and functionality increases by providing appropriate loading. What kind of changes occur in the core muscles due to the strengthening of the core muscles as a result of spinal stabilization exercises is an important question that needs to be clarified scientifically. It is possible to observe the mechanical changes occurring in the core muscles with shear wave elastography, which has been frequently used in clinical research and practice in recent years. However, in the detailed literature review, no scientific studies were found that evaluated what level of exercise intensity produces optimal changes in the muscle and the correlation of these changes with pain and functional improvement. In this study, where different intensities of exercise will be applied, the mechanical changes occurring in the core muscles before and after exercise will be evaluated with shear wave elastography and the aim is to evaluate the correlation of these changes with pain and pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

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

January 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2025

Completed
Last Updated

August 7, 2025

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

January 18, 2024

Last Update Submit

August 3, 2025

Conditions

Keywords

low back paincore stabilityultrasonographydisabilityelasticity

Outcome Measures

Primary Outcomes (1)

  • Evaluation of muscle elasticity with elastography

    The mechanical properties of the transversus abdominis, one of the core muscles, will be evaluated by the shear wave elastography method.

    before treatment and 12nd (end of treatment) week of treatment

Secondary Outcomes (3)

  • visual analog scale

    before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment

  • oswestry disability index

    before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment

  • evaluation of pain sensitivity

    before treatment, 6th week of treatment and 12nd (end of treatment) week of treatment

Study Arms (3)

exercise group twice a week

ACTIVE COMPARATOR

Spinal stabilization exercises determined by the authors will be applied 2 days a week for 40 minutes.

Other: spinal stabilization exercise

exercise group four times a week

ACTIVE COMPARATOR

Spinal stabilization exercises determined by the authors will be applied 4 days a week for 40 minutes.

Other: spinal stabilization exercise

control group

NO INTERVENTION

Patients will be followed with a home exercise program

Interventions

The exercise program will be implemented in the hospital under the supervision of a physiotherapist for 6 weeks, and the next 6 weeks will be followed as a home program. The first group will be given an exercise program 2 days a week, the second group will be given an exercise program 4 days a week. The exercise program is planned to be 40 minutes and the first 5 minutes of the program will be warm-up and the last 5 minutes will be cool-down exercises.

exercise group four times a weekexercise group twice a week

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic low back pain for at least 3 months.
  • Not having participated in any physiotherapy or exercise program in the last month.
  • Patients with informed consent

You may not qualify if:

  • Malignancy
  • Severe osteoporosis
  • Arthritis
  • Bone diseases
  • Pregnancy
  • Diabetics
  • Lumbar or lower limb surgery
  • Rheumatological and inflammatory problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hasan Kalyoncu University

Gaziantep, Gaziantep, 27000, Turkey (Türkiye)

Location

Adıyaman training and research hospital

Adıyaman, 02000, Turkey (Türkiye)

Location

Related Publications (1)

  • Akbas E, Ozdemir M, Akbas A, Usgu S, Bulut HT. Investigation of the effect of different intensity stabilization exercises on core muscle stiffness and pain in chronic low back pain: a single-blind, randomized controlled trial. Rheumatol Int. 2025 Aug 19;45(9):201. doi: 10.1007/s00296-025-05964-7.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • abuzer akbas

    hasan kalyoncu university faculty of health science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups of exercise and a control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 29, 2024

Study Start

April 22, 2024

Primary Completion

February 26, 2025

Study Completion

March 13, 2025

Last Updated

August 7, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations