NCT06837753

Brief Summary

Low back pain is one of the most common complaints in the world and can be considered a universal health problem for humanity. Low back pain is a multifactorial disease with multiple etiologies. Risk factors are difficult to identify. It is reported in the literature that 70-80% of the world's population has low back pain at some point in their lives, and 95% of this pain is mechanical. Mechanical low back pain (MBA) can be described as a clinical picture that develops as a result of overuse, strain, traumatization or deformation of the structures that make up the spine. In order to define low back pain mechanically, all organic causes such as inflammatory, infectious, tumoral, metabolic causes, fractures and pain reflected from internal organs must be excluded. The most common diseases that cause low back pain are; They are caused by mechanical factors and degenerative diseases. Mechanical and static stresses can lead to joint blockage, restricting the range of motion of the joint along with pain. Non-Specific many factors affect low back pain. Kim and Shin reported that asymmetry of hip extension range of motion of both hip joints was associated with nonspecific low back pain rather than simple hip extension range of motion, and they found that limiting hip extension was compensatory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable low-back-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

20 days

First QC Date

December 13, 2023

Last Update Submit

February 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain status

    Pain status Patients pain status were evaluated with VAS between 0 and 10 for low back pain during movement. (No pain at 0 points, severe pain at 10 points)

    0-8 week

  • Flexibility assessment

    During Single Leg Raise, subjects were asked to indicate (by pushing a button) the beginning of pain or an unpleasant tension sensation in the dorsal part of the thigh off the knee. This first sensation of pain was recorded as a function of the pelvic-femoral angle. Subjects were also instructed to push the button and to say "stop" when they could no longer tolerate more movement or stretch; at that point, the leg raise was stopped. The stretch tolerance was defined by the extensibility of the hamstrings. Note that the subjects stopped the leg raise.

    0-8 week

Secondary Outcomes (2)

  • Functionality index

    0-8 week

  • FUNCTIONAL STATUS

    0-8 week

Study Arms (2)

exercise group

EXPERIMENTAL

Exercise program and 3 way hamstring strech will be applied.

Other: Exercise

control group

OTHER

Just Exercise program will be applied.

Other: Exercise

Interventions

It consist of traditional exercises.

control groupexercise group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with complaints of low back pain,
  • NLBP for at least 12 weeks,
  • finger-to-ground distance greater than 0 cm; a passive straight-leg raising -(SLR) angle of less than 80°, measured with a hand-held goniometer;
  • normal mobility of the hip;
  • passive knee extension ≥25°,
  • VAS score between 3 and 7 will be included.

You may not qualify if:

  • People with a history of hamstring injury in the last two years,
  • fractures in the spine or lower extremities,
  • pregnancy,
  • leg length difference of more than 2 cm,
  • and obesity will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eylül Pınar Kısa

Istanbul, Istanbul, 34720, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Investigators

Study Record Dates

First Submitted

December 13, 2023

First Posted

February 20, 2025

Study Start

December 12, 2023

Primary Completion

January 1, 2024

Study Completion

August 10, 2024

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations