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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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

Other trials in Turkey (Türkiye)

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 groups in NCT07061743
Study groupRoleWhat they receive
low back pain groupExperimentalNot described
Receives: Behavioral: activity management training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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"

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted11 Jul 2025
  2. Study start3 Jul 2025 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion30 Oct 2025 (estimated)

Resources

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)
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

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.

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