Low Back PainNCT07061743
Activity Management Training in Low Back Pain
A study testing activity management training in people with Low Back Pain, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
The individuals participating in the study will be asked to fill in the Body Awareness Scale, Canadian Activity Performance Measure, Pain Activity Patterns Scale, Cognitive Status Scale, and Fatigue Severity Scale. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- activity management training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: literate individuals who have been complaining of low back pain for at least 3-6 months, who are willing to participate in the study -
Exclusion Criteria: Those with complaints of musculoskeletal pain due to cancer, fracture, or surgery in the last 6 months, those with serious psychiatric disorders such as panic disorder or major depression, and those who did not volunteer to participate in the study
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Çankırı Karatekin University
Çankırı, Uluyazı, 18100
Nilay Şahan, 05054671090, nilaysahan@karatekin.edu.tr
About this study
Official title: The Effect of Activity Management Training on Body Awareness, Cognitive Functions and Fatigue in Individuals With Chronic Low Back Pain
The individuals participating in the study will be asked to fill in the Body Awareness Scale, Canadian Activity Performance Measure, Pain Activity Patterns Scale, Cognitive Status Scale, and Fatigue Severity Scale. Afterwards, colour block design, puzzle making, and picture sorting subtests of the Loewenstein Occupational Therapy Cognitive Assessment will be applied to the individuals. After the initial assessments, activity management training will be provided to the patients. In the activity management training, first week awareness training, second week ergonomics training, third week activity stepping training, fourth week joint-energy conservation training, and fifth week relaxation training will be given. In the sixth and last week, the goals set will be reviewed. All pre-treatment tests will be re-administered at 6 weeks post-treatment. All applications will be carried out within Çankırı Karatekin University.
- Conditions
- Low Back Pain
- Being tested
- activity management training
- Keywords
- Low back Pain, activity management training, cognitive function, fatique
- 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.
activity management trainingBehavioural
In activity management training, first week awareness training, second week ergonomics training, third week activity stepping training, fourth week joint-energy conservation training, and fifth week relaxation training will be given.
| Study group | Role | What they receive |
|---|---|---|
| low back pain group | Experimental | Not described Receives: Behavioral: activity management training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
The COPM is used to assess individuals' activity performance and satisfaction levels. In this assessment scale, the problems encountered by individuals in the field of activity performance are determined through a semi-structured interview. Individuals evaluate their activity performance problems with their own performance and satisfaction scores. In the first step, individuals are asked to identify the problems in the areas of self-care, productivity and leisure time that they do, want to do or have difficulty in doing in their routine. In the second step, individuals are asked to assign an importance value between 1 and 10 to each of these activities. In the third step, individuals are asked to select up to 5 activities that are most important for them and to give performance and satisfaction scores between 1 and 10 for each activity. The performance and satisfaction scores are totalled and divided by the number of activities to obtain performance and satisfaction scores.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (6)
Body Awareness Questionnaire
The body awareness of the participants will be evaluated with the Body Awareness Questionnaire (BAQ) developed by Shields (31). The Turkish validity and reliability of the questionnaire was conducted by Karaca (2017). The questionnaire consists of four subscales (Note Changes in Response or Body Process, Predict Body Response, Onset of Illness, and Sleep-Wake Cycle) and 18 questions in total. The questionnaire is scored on a 7-point Likert scale ranging from 'Not true for me' (1) to 'Completely true for me' (7).
Measured: From enrollment to the end of treatment at 6 weeks"
Pain Activity Patterns Scale (PAPS)
The PAPS is a scale that determines the changing activity patterns in individuals with chronic pain in 3 subgroups as avoidance, excessive avoidance and regularisation. It was developed by Cane et al. in Canada. The AAPS consists of 3 subgroups, including avoidance, excessive avoidance, and regularisation, and a total of 30 questions, 10 for each subgroup. In the scale, individuals with chronic pain are asked to answer questions about how they perform activities of daily living. In answering the questions in the scale, a 5-point Likert scoring system is used, 0-never, 2-sometimes, 4-always. In the calculation of the scale score, separate score calculations are made for the subgroups of avoidance, overdoing, and regularisation. The total scores calculated for the subgroups vary between 0-40 points separately. Within these 3 subgroups, the subgroup with the highest score by the patient is determined and it is determined which subgroup the participant adopts in activities of daily living
Measured: From enrollment to the end of treatment at 6 weeks
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
The Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) will be used in the study to evaluate the basic cognitive skills of individuals. The test consists of 22 items, including 2 items of orientation, 6 items of visual-spatial perception, 7 items of visual-motor organisation, 6 items of thinking skills, and 1 item of attention. The content of the test (36): Orientation: 1. Time orientation 2. Place orientation Visual perception: 1. object recognition 2. shape recognition 3. overlapping figures 4. object invariance 5. spatial perception 6. praxis Visual-motor organisation: 1. Geometric shape copying 2. Two-dimensional model 3. Pegboard construction 4. Coloured block design 5. Plain block design 35 6. Jigsaw puzzle 7. Clock drawing Thinking Skills: 1. Categorisation 2. Risca Object Classification I - structured (Risca Object Classification- ROC I) 3. Riska Object Classification II - unstructured (ROC II) 4. Picture Sorting A 5. Picture Sorting B 6. Geometric Sorting Attention
Measured: From enrollment to the end of treatment at 6 weeks
Stroop test
The Stroop Test is a neuropsychological test that reflects frontal region activity. It measures the brain's ability to direct attention, conceptual flexibility and mental processing speed. In the first stage of the Stroop attention test, people are presented with the names of colours and asked to read these colours quickly. For example, no matter what colour the font is, it will be read as 'red'. In the second step, they are asked to quickly say what colour the dot clusters printed through ink are. For example, if the word 'red' is written in yellow font, they should say "yellow" instead of 'red'. In the final stage of the test, the third stage, the participants are asked to say the words written in a different colour than the name of the colour as fast as possible in a loud voice. For example, the word 'blue' is written in red or black. As a result of these experiments, the Stroop effect occurs. When it was investigated with imaging techniques where the Stroop effect affects the hum
Measured: From enrollment to the end of treatment at 6 weeks
Cognitive Status Scale
It was developed by Broadbent et al. to assess cognitive failures that occur in daily life. Failures in perception, memory, and motor functions are assessed with 25 questions. Each question is scored between 0 (never) and 4 (very often) in the scale consisting of questions such as 'Do you ever find yourself accidentally hiding what you should throw away and throwing away what you should keep?', 'Do you ever forget people's names?', 'Do you drop things?'. The total score ranges from 0-100, with a higher score indicating an increased level of cognitive failure. The validity and reliability study of the Turkish version of the scale was conducted by Ekici et al.
Measured: From enrollment to the end of treatment at 6 weeks
Fatigue Severity Scale
The scale was developed by Krup et al. (1989), and its Turkish validity and reliability were examined by Armutlu et al. (2007). The scale has 9 questions and one dimension. The individual indicates the level of agreement with the items in the scale by choosing a number from 1 (strongly disagree) to 7 (strongly agree). A total score of 9-63 can be obtained from the scale. A total score of 36 or more indicates severe fatigue
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start3 Jul 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
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 Low Back PainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Şahan, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061743
- Sponsor's protocol ID
- 8d4b4754e30644ac
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahan N, Turkmen C, Arslan T, Sigirtmac IC, Yazici Gulay M. Changes in functional outcomes following activity management training in individuals with chronic low back pain: associations with cognitive functions, body awareness, and fatigue. Pain Manag. 2026 Oct 15:1-10. doi: 10.1080/17581869.2026.2748301. Online ahead of print.
PubMed 42876320
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Activity Management Training on Body Awareness, Cognitive Functions and Fatigue in Individuals With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07061743
- Acronym / sponsor ID
- 8d4b4754e30644ac
- Conditions
- Low Back Pain
- Keywords
- Low back Pain, activity management training, cognitive function, fatique
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 3 Jul 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 11 Jul 2025 (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.
The individuals participating in the study will be asked to fill in the Body Awareness Scale, Canadian Activity Performance Measure, Pain Activity Patterns Scale, Cognitive Status Scale, and Fatigue Severity Scale. Afterwards, colour block design, puzzle making, and picture sorting subtests of the Loewenstein Occupational Therapy Cognitive Assessment will be applied to the individuals. After the initial assessments, activity management training will be provided to the patients. In the activity management training, first week awareness training, second week ergonomics training, third week activity stepping training, fourth week joint-energy conservation training, and fifth week relaxation training will be given. In the sixth and last week, the goals set will be reviewed. All pre-treatment tests will be re-administered at 6 weeks post-treatment. All applications will be carried out within Çankırı Karatekin University.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low back pain group | Experimental | Behavioral: activity management training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| activity management trainingIn activity management training, first week awareness training, second week ergonomics training, third week activity stepping training, fourth week joint-energy conservation training, and fifth week relaxation training will be given. | Behavioural | low back pain group |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: From enrollment to the end of treatment at 6 weeks
The COPM is used to assess individuals' activity performance and satisfaction levels. In this assessment scale, the problems encountered by individuals in the field of activity performance are determined through a semi-structured interview. Individuals evaluate their activity performance problems with their own performance and satisfaction scores. In the first step, individuals are asked to identify the problems in the areas of self-care, productivity and leisure time that they do, want to do or have difficulty in doing in their routine. In the second step, individuals are asked to assign an importance value between 1 and 10 to each of these activities. In the third step, individuals are asked to select up to 5 activities that are most important for them and to give performance and satisfaction scores between 1 and 10 for each activity. The performance and satisfaction scores are totalled and divided by the number of activities to obtain performance and satisfaction scores.
6 secondary outcomes
Body Awareness Questionnaire
Time frame: From enrollment to the end of treatment at 6 weeks"
Pain Activity Patterns Scale (PAPS)
Time frame: From enrollment to the end of treatment at 6 weeks
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Time frame: From enrollment to the end of treatment at 6 weeks
Stroop test
Time frame: From enrollment to the end of treatment at 6 weeks
Cognitive Status Scale
Time frame: From enrollment to the end of treatment at 6 weeks
Fatigue Severity Scale
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Derived from this study: PubMed 42876320Sahan N, Turkmen C, Arslan T, Sigirtmac IC, Yazici Gulay M. Changes in functional outcomes following activity management training in individuals with chronic low back pain: associations with cognitive functions, body awareness, and fatigue. Pain Manag. 2026 Oct 15:1-10. doi: 10.1080/17581869.2026.2748301. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing activity management training in people with Low Back Pain, run by Çankırı Karatekin University 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?
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: opening soon, as of the sponsor's last update on 11 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilay Şahan, PhD (+905054671090, nilaysahan@karatekin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: From enrollment to the end of treatment at 6 weeks). 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 NCT07061743, 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 11 Jul 2025.