Chronic PainNCT07491549
The Effect of Pain Education Group Therapy and Its Impact on Chronic Pain, Kinesiophobia, and Physical Activity
A study testing pain education in people with Chronic Pain, run by University of Tartu at 1 site in Estonia.
Trial summary
The goal of this clinical trial is to learn if pain knowledge group intervention among chronic pain patients would influence their level of physical activity, pain intensity, depression, kinesiophobia and central sensitization. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- pain education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Apr 2026to 30 Dec 2030
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pain lasting longer than 3 months,
- Consequences resulting from long-term pain (such as decreased physical activity, sleep disturbances, fatigue, low mood, etc.)
Who cannot join
- Surgery that occurred less than 3 months prior
- Fracture or limb trauma that occurred less than 3 months prior
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mati Arendi, PhD contact
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, Tartu, 50406
Hanna Kalajas-Tilga, PhD, 372 58361041, hanna.kalajas-tilga@ut.ee
About this study
Official title: Physical Activity in Patients With Chronic Pain, Its Adherence to WHO Physical Activity Recommendations, and Its Associations With Kinesiophobia, Central Sensitization, Depression, and Pain Intensity
The goal of this clinical trial is to learn if pain knowledge group intervention among chronic pain patients would influence their level of physical activity, pain intensity, depression, kinesiophobia and central sensitization. The main question it aims to answer is:
Primary hypothesis: pain education will decrease participants' depression and pain intensity and increase their physical activity.
There is no comparison group.
Participants will participate in a 6-week pain knowledge intervention where they will be learning about sleep, stress models, physical activity benefits, pain neurobiology, mindfulness, pain medication.
- Conditions
- Chronic Pain
- Being tested
- pain education
- Keywords
- chronic pain, depression, pain education, physical activity, kinesiophobia
- Medical subject headings
- Chronic Pain, Depression, Motor Activity, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain educationBehavioural
Also called pain neuroscience education, pain management education
In one group there will be 8-12 participants who will meet once a week during 6 -weeks time. The educational sessions will be 2-hours long including sometimes some exercises and also reflection of the participants.
| Study group | Role | What they receive |
|---|---|---|
| Pain education intervention | Experimental | The participants will receive a 6-week pain education in groups. In addition, they are asked to wear an Actigraph to measure their actual physical activity. The topics in the pain education group are as follows:
1. The pain management team - the patient as the supportive leader of the team
2. Contemporary understanding of the biopsychosocial nature of pain
3. Stress and its impact on pain
4. Use of medications in the treatment of chronic pain
5. Physical activity and its impact on pain
6. Negative thoughts and their impact on pain
7. Use of relaxation and mindfulness techniques in pain management
8. Sleep and sleep hygiene
9. Setbacks and coping with them Receives: Behavioral: pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain intensity from baseline to 6-weeks
Pain is measured using Graded Chronic Pain Scale -Revised where the lowest value is 0 and the highest is 100. The higher the score, the more pain the subject feels.
Measured: from enrollment to the end of treatment at 6 weeks
Change of pain intensity from baseline to 6-weeks
Pain is measured using Brief Pain Inventory Short form where the lowest value is 0 and the highest value is 10. The higher the score, the more pain the subject feels.
Measured: from enrollment to the end of treatment at 6 weeks
Secondary outcomes (1)
Change in depression from baseline to 6-weeks
Depression is measured using Emotional well-being questionnaire where the lowest value is 0 and the highest value is 100. Lower score indicates worse health condition.
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 posted24 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Kalajas-Tilga, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491549
- Sponsor's protocol ID
- ChronicPain
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We might share the data of the participants on OpenScience Platform
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Patients With Chronic Pain, Its Adherence to WHO Physical Activity Recommendations, and Its Associations With Kinesiophobia, Central Sensitization, Depression, and Pain Intensity
- ClinicalTrials.gov ID
- NCT07491549
- Acronym / sponsor ID
- ChronicPain
- Conditions
- Chronic Pain
- Keywords
- chronic pain, depression, pain education, physical activity, kinesiophobia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 24 Mar 2026 (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 goal of this clinical trial is to learn if pain knowledge group intervention among chronic pain patients would influence their level of physical activity, pain intensity, depression, kinesiophobia and central sensitization. The main question it aims to answer is:
Primary hypothesis: pain education will decrease participants' depression and pain intensity and increase their physical activity.
There is no comparison group.
Participants will participate in a 6-week pain knowledge intervention where they will be learning about sleep, stress models, physical activity benefits, pain neurobiology, mindfulness, pain medication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain education intervention | Experimental | Behavioral: pain educationThe participants will receive a 6-week pain education in groups. In addition, they are asked to wear an Actigraph to measure their actual physical activity. The topics in the pain education group are as follows: 1. The pain management team - the patient as the supportive leader of the team 2. Contemporary understanding of the biopsychosocial nature of pain 3. Stress and its impact on pain 4. Use of medications in the treatment of chronic pain 5. Physical activity and its impact on pain 6. Negative thoughts and their impact on pain 7. Use of relaxation and mindfulness techniques in pain management 8. Sleep and sleep hygiene 9. Setbacks and coping with them |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pain lasting longer than 3 months,
- Consequences resulting from long-term pain (such as decreased physical activity, sleep disturbances, fatigue, low mood, etc.)
Key exclusion criteria (2 listed)
- Surgery that occurred less than 3 months prior
- Fracture or limb trauma that occurred less than 3 months prior
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 |
|---|---|---|
| pain educationAlso: pain neuroscience education, pain management educationIn one group there will be 8-12 participants who will meet once a week during 6 -weeks time. The educational sessions will be 2-hours long including sometimes some exercises and also reflection of the participants. | Behavioural | Pain education intervention |
Primary outcome
Change of pain intensity from baseline to 6-weeks
Time frame: from enrollment to the end of treatment at 6 weeks
Pain is measured using Graded Chronic Pain Scale -Revised where the lowest value is 0 and the highest is 100. The higher the score, the more pain the subject feels.
Change of pain intensity from baseline to 6-weeks
Time frame: from enrollment to the end of treatment at 6 weeks
Pain is measured using Brief Pain Inventory Short form where the lowest value is 0 and the highest value is 10. The higher the score, the more pain the subject feels.
1 secondary outcome
Change in depression from baseline to 6-weeks
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 30 Mar 2026.
- Individual participant dataSharing planned: No. We might share the data of the participants on OpenScience Platform
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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.
Mati Arendi, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain education in people with Chronic Pain, run by University of Tartu at 1 site in Estonia.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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 Estonia. 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 Hanna Kalajas-Tilga, PhD (+372 5816 1041, hanna.kalajas-tilga@ut.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain intensity from baseline to 6-weeks (time frame: from enrollment to the end of treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.