- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491549
The Effect of Pain Education Group Therapy and Its Impact on Chronic Pain, Kinesiophobia, and Physical Activity
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hanna Kalajas-Tilga, PhD
- Phone Number: +372 5816 1041
- Email: hanna.kalajas-tilga@ut.ee
Study Contact Backup
- Name: Mati Arendi, PhD
Study Locations
-
-
Tartu
-
Tartu, Tartu, Estonia, 50406
- Recruiting
- Tartu University Hospital
-
Contact:
- Hanna Kalajas-Tilga, PhD
- Phone Number: 372 58361041
- Email: hanna.kalajas-tilga@ut.ee
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pain lasting longer than 3 months,
- Consequences resulting from long-term pain (such as decreased physical activity, sleep disturbances, fatigue, low mood, etc.)
Exclusion Criteria:
- Surgery that occurred less than 3 months prior
- Fracture or limb trauma that occurred less than 3 months prior
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain education intervention
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:
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
from enrollment to the end of treatment at 6 weeks
|
|
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.
|
from enrollment to the end of treatment at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depression from baseline to 6-weeks
Time Frame: from enrollment to the end of treatment at 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.
|
from enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChronicPain
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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