- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722457
Comparison of the Effects of External Focus and Internal Focus Instructions Applied Chronic Low Back Pain: RCT
Comparison of the Effects of External Focus and Internal Focus Instructions Applied in Balance Training on Individuals With Chronic Low Back Pain: Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
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)". Many previous studies have shown that external focus is substantially more effective than internal focus in the performance of a movement.In our randomized controlled study, there were two groups and 22 people were treated in each group. Volunteers between the ages of 18-65 who had low back pain for the last 3 months and had no musculoskeletal problems were included. Balances were evaluated with Biodex Balance Device, pain with Visual Analog Scale, performance with Physical Performance Test Battery, functional level with osvewstry disability index, posture, spinal mobility,postural endurance with spinal mouse device. 8 weeks of treatment were applied to both groups as external focus and control groups. Basically similar exercises were applied to both groups, and there were tasks in the exercises in the external focus group, and the focus were on the task other than the exercise.
The results of the study show that externally focused balance exercises are effective on dynamic balance, fall risk, stability limits, physical performance, posture, spinal mobility, and postural endurance in individuals with CLBP.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kirşehi̇r
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Kırşehir, Kirşehi̇r, Turkey
- Kirşehir Ahi Evran Univercity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- Subjects who do not cooperate well will not be included in the study. Inclusion and exclusion criteria will be the same for control group participants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Investigation of the Effects of External Focused Ex. on Functionality in Individuals
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.
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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.
Other Names:
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|
Other: Investigation of the Effects of İnternal Focused Ex. on Functionality in Individuals
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 8 weeks
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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.
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8 weeks
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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.
Time Frame: 8 weeks
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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"
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8 weeks
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The Physical Performance Level
Time Frame: 8 weeks
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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.
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8 weeks
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Balance
Time Frame: 8 weeks
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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
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8 weeks
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Assessment of Posture, Spinal Mobility, and Postural Endurance Spinal Mobilite
Time Frame: 8 weeks
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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.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: anıl özüdoğru, Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitationaozudogru@hotmail.com
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-0003-0145-3565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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