Physical Therapy TechniquesNCT05722457
Comparison of the Effects of External Focus and Internal Focus Instructions Applied Chronic Low Back Pain: RCT
A study testing external focus task focus in addition to physiotherapy and rehabilitation exercises and internal focus task focus in addition to physiotherapy and rehabilitation exercises in people with Physical Therapy Techniques, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physical Therapy Techniques
- What is being tested?
- external focus task focus in addition to physiotherapy and rehabilitation exercises and internal focus task focus in addition to physiotherapy and rehabilitation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2023to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirşehir Ahi Evran Univercity
Kırşehir, Kirşehi̇r
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Physical Therapy Techniques
- Being tested
- external focus task focus in addition to physiotherapy and rehabilitation exercises, internal focus task focus in addition to physiotherapy and rehabilitation exercises
- Keywords
- Physical Therapy, low back pain,, external focus
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external focus task focus in addition to physiotherapy and rehabilitation exercisesOther
Also called ext focus
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.
internal focus task focus in addition to physiotherapy and rehabilitation exercisesOther
Also called internal focus
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: internal focus task focus in addition to physiotherapy and rehabilitation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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"
Measured: 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.
Measured: 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
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start5 Mar 2023
- Primary completion15 Jun 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical Therapy TechniquesStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups will be formed using the random randomization model
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safak Kuzu, Kirsehir Ahi Evran Universitesi
- Investigators
- anıl özüdoğru, Principal investigator, Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitationaozudogru@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722457
- Sponsor's protocol ID
- 0000-0003-0145-3565
- Status last verified
- Oct 2023
- First submitted
- 30 Dec 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ıpd Decision will be made after ipd data is collected.
Publications
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.
PubMed 10380243
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05722457
- Acronym / sponsor ID
- 0000-0003-0145-3565
- Conditions
- Physical Therapy Techniques
- Keywords
- Physical Therapy, low back pain,, external focus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups will be formed using the random randomization model
| Arm | Type | Receives |
|---|---|---|
| Investigation of the Effects of External Focused Ex. on Functionality in Individuals | Other | Other: external focus task focus in addition to physiotherapy and rehabilitation exercisesSub-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. |
| Investigation of the Effects of İnternal Focused Ex. on Functionality in Individuals | Other | Other: internal focus task focus in addition to physiotherapy and rehabilitation exercisesSub-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external focus task focus in addition to physiotherapy and rehabilitation exercisesAlso: ext focusThe 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 | Investigation of the Effects of External Focused Ex. on Functionality in Individuals |
| internal focus task focus in addition to physiotherapy and rehabilitation exercisesAlso: internal focushe 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 | Investigation of the Effects of İnternal Focused Ex. on Functionality in Individuals |
Primary outcome
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
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.
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
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"
The Physical Performance Level
Time frame: 8 weeks
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.
Balance
Time frame: 8 weeks
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
Assessment of Posture, Spinal Mobility, and Postural Endurance Spinal Mobilite
Time frame: 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 10380243Wulf 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.
- Individual participant dataSharing planned: No. ıpd Decision will be made after ipd data is collected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
anıl özüdoğru principal investigator
Kırşehir Ahi Evran University School of Physical Therapy and Rehabilitationaozudogru@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external focus task focus in addition to physiotherapy and rehabilitation exercises and internal focus task focus in addition to physiotherapy and rehabilitation exercises in people with Physical Therapy Techniques, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05722457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.