NCT05722457

Brief Summary

Postural control methods are impaired in people with chronic low back pain. While the person maintains balance with pain relief, fear of movement and pain increase with loss of balance. It was found that externally focused exercises are more effective than internal focus exercises in terms of motor control and motor learning. To investigate the place of externally focused balance exercises in conservative treatment of target low back pain. For this purpose, approval was obtained from the clinical research ethics committee of Kırşehir Ahi Evran University, Faculty of Medicine, with the decision numbered 2022-18/163.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

March 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

December 30, 2022

Last Update Submit

October 30, 2023

Conditions

Keywords

Physical Therapylow back pain,external focus

Outcome Measures

Primary Outcomes (5)

  • Pain level Individuals are asked to indicate the degree of pain they have on the VAS scale numbered from 0 to 10 on a straight line, with "0" being no pain and "10" being the most severe pain.

    The units included in the study are the use of VAS (Visual Analog Scale) for the presence and burden of low back pain. At the beginning and end of each start-up, the presence and effect of pain is asked and taken away. The reason for preferring these variables VAS is that they have high validity and reliability. Individuals are asked to indicate the degree of pain they have on the VAS scale numbered from 0 to 10 on a straight line, with "0" being no pain and "10" being the most severe pain.

    8 weeks

  • Evaluation of Functional Status (Oswestry Disability Index) Physical functions .The result is calculated with the formula "patient's score / probable maximum score X 100". Each question has an answer rating from 0 to 5.

    Oswestry Disability Scale Evaluation of Physical Function Evaluation of Functional Status (Oswestry Disability Index) Physical functions will be evaluated with the Oswestry low back pain scale. It is a very common scale compiled to evaluate the general condition of the low back in patients with low back pain. Scoring of the answered questions is carried out by adding the numbers next to the checked box. Each question has an answer rating from 0 to 5. The maximum score can be 50 if the individual has answered each question. The result is calculated with the formula "patient's score / probable maximum score X 100"

    8 weeks

  • The Physical Performance Level

    The physical performance test battery includes the following tests: lumbar flexion range of motion, walking fifty steps, walking for 5 minutes, sitting and standing with 5 repetitions, trunk flexion with 10 repetitions, and reaching forward with weight.

    8 weeks

  • Balance

    The Biodex stability system (Biodex Medical System Inc., NY, USA, Model SW4530DE6N, SD 950304) was used to assess static and dynamic balance, fall risk, and the limit of stability

    8 weeks

  • Assessment of Posture, Spinal Mobility, and Postural Endurance Spinal Mobilite

    Spinal posture, spinal mobility, and postural competence were measured with a computer-assisted wireless Spinal Mouse device (the Spinal Mouse System, Idiag, Fehraltorf, Switzerland). By moving the Spinal Mouse device on the spine with its wheel, it measures the length of the spine, posture, and joint movements and transfers this sequence to the computer environment. Trunk flexion posture was recorded for spinal mobility. Upright posture was measured for the postural endurance (competence) values, and then, after holding a weight of 5% of the person's body weight between the hands parallel to the shoulder level for 30 seconds, the upright posture was re-measured while the weight was still in the person's hand.

    8 weeks

Study Arms (2)

Investigation of the Effects of External Focused Ex. on Functionality in Individuals

OTHER

Sub-branches of the study are planned as Investigation of the Effects of External Focused Dynamic Balance Training on Functionality in Individuals with Chronic Low Back Pain. Sub-branches of the study are planned as Investigation of the Effects of External Focused Dynamic Balance Training on Functionality in Individuals with Chronic Low Back Pain.

Other: external focus task focus in addition to physiotherapy and rehabilitation exercises

Investigation of the Effects of İnternal Focused Ex. on Functionality in Individuals

OTHER

Sub-branches of the study are planned as Investigation of the Effects of internal Focused Dynamic Balance Training on Functionality in Individuals with Chronic Low Back Pain. Sub-branches of the study are planned as Investigation of the Effects of İnternal Focused Dynamic Balance Training on Functionality in Individuals with Chronic Low Back Pain.

Other: internal focus task focus in addition to physiotherapy and rehabilitation exercises

Interventions

The first study on the external focus was made in 1998 by Wulf, Ho ¨ß, \& Prinz, (1998). Focusing on the inside of the body while performing a movement is called "internal (internal focus)", focusing on the outside of the body is called "external (external focus)". Previous studies have shown that external focus is substantially more effective than internal focus in the performance of a movement.

Also known as: ext focus
Investigation of the Effects of External Focused Ex. on Functionality in Individuals

he first study on the external focus was made in 1998 by Wulf, Ho ¨ß, \& Prinz, (1998). Focusing on the inside of the body while performing a movement is called "internal (internal focus)", focusing on the outside of the body is called "external (external focus)". Previous studies have shown that external focus is substantially more effective than internal focus in the performance of a movement.

Also known as: internal focus
Investigation of the Effects of İnternal Focused Ex. on Functionality in Individuals

Eligibility Criteria

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

You may qualify if:

  • Those with ongoing low back pain symptoms in the last three months (diagnosed with chronic low back pain),
  • Individuals between the ages of 18-65
  • Pain level 3 or more according to VAS
  • Individuals who volunteer to participate in the study will be included.

You may not qualify if:

  • Individuals with lower extremity and spine orthopedic and neurological disorders,
  • Having a musculoskeletal injury in the last 9 months,
  • Surgery, injection, etc. for low back pain in the last 3 months. with a history of treatment
  • Those who are doing any sports activity,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirşehir Ahi Evran Univercity

Kırşehir, Kirşehi̇r, Turkey (Türkiye)

Location

Related Publications (1)

  • Wulf G, Lauterbach B, Toole T. The learning advantages of an external focus of attention in golf. Res Q Exerc Sport. 1999 Jun;70(2):120-6. doi: 10.1080/02701367.1999.10608029.

    PMID: 10380243BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • anıl özüdoğru

    Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitationaozudogru@hotmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the participant and evaluator do not know who the groups are
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups will be formed using the random randomization model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant/Araştırma Görevlisi

Study Record Dates

First Submitted

December 30, 2022

First Posted

February 10, 2023

Study Start

March 5, 2023

Primary Completion

June 15, 2023

Study Completion

July 20, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

ıpd Decision will be made after ipd data is collected.

Locations