PainNCT01381263
Behavioral Medicine Treatment for Adolescents in Pain
A study testing Behavioural medicine treatment and Standard treatment in people with Pain, run by Uppsala University at 1 site in Sweden.
Trial summary
Recurrent pain, such as headache, stomach pain and musculoskeletal pain is common in children and adolescents. Children and adolescents are reported to have restrictions in daily life activities, social contacts, and school attendance, and to have poorer academic skills and as well as an increased utilization of heath… Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Pain
- What is being tested?
- Behavioural medicine treatment and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Dec 2013
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescents with pain and interference of daily activities due to pain, referred to paediatric physiotherapy in a primary health setting will be included.
- Participants must understand written and oral Swedish and have had persistent pain for more than 6 weeks or recurrent pain more than once a week for over three months.
- The adolescents´ parents will be included in a brief intervention.
Who cannot join
- Subjects with resent trauma, ongoing treatment for any psychiatric illness or cognitive problems will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Evaluation and Cost Effectiveness of a Treatment Program With a Behavioural Medicine Approach for Adolescents With Persistent Pain.
Recurrent pain, such as headache, stomach pain and musculoskeletal pain is common in children and adolescents. Children and adolescents are reported to have restrictions in daily life activities, social contacts, and school attendance, and to have poorer academic skills and as well as an increased utilization of heath care services due to pain problems. The treatment approaches available today for teenagers with pain are often biological/physiological and little evidence for their effectiveness has been shown. It is urgent to try new interventions for pain problems in early ages in order to prevent disability, development of maladaptive coping strategies and to avoid negative impact on daily activities.
The optimal treatment regime for paediatric pain patients has been suggested to be cognitive behavioural approach integrated with physical therapy The aim of this project is to develop and evaluate in a randomized controlled trial a treatment program with a behavioural medicine approach (suitable to use in primary care or school based health care context) compared with standard treatment for adolescents with persistent pain problems. The aim is also to compare short and long-term costs for patients and for the health care system related to the two interventions, in order to determine strategies for future cost-effective care of children and adolescents experiencing recurrent pain.
Read the detailed description
Chronic or recurrent pain symptoms are widely studied and generally regarded as an important public health concern in adults. The prevalence of pain symptoms are reported to be as high as 25-30 % in children and adolescents. Children and adolescents are reported to have restrictions in daily life activities, social contacts, and school attendance, and to have poorer academic skills and as well as an increased utilization of heath care services due to pain problems. These patients suffer from a wide variety of problems, for example sports injuries, persistent postoperative pain, musculoskeletal pains, headaches or multiple recurrent pain problems. The treatments given today to adolescents are dealing with symptoms in a physical manner.
In this study participants will be recruited among adolescents referred to paediatric physiotherapy. The participants will be randomly allocated to either physiotherapy including standard treatment or a behavioural medicine treatment program. Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis.
The behavioural medicine treatment program will include the same components as the standard treatment with the addition of age appropriate interventions aimed to address the emotional and behavioural processes of pain. The treatment is based on earlier intervention programs and includes the following phases;
- Individual functional behavioural analysis The adolescents lists specific important and frequent activities and situations they have problems to master due to pain and target activities are then chosen. Individual capabilities (both physical and psychological), behavioural responses, and their short and long-term consequences are identified. Parental responses and their impact on adolescent's pain behaviours are noted. Target activity related treatment goals as well goals for engagement in the treatment are defined from the individual functional behavioural analysis.
- Basic skill acquisition Physical abilities and cognitive skills required for improvement of behaviour in target activities are trained. For example to meet the problem of fear of movement, graded activity, or exposure will be provided. When negative thoughts are recognized the adolescents are taught and trained on how to replace these thoughts, self-efficacy for target activities are increased by carefully selected activities witch allows the adolescent to succeed and by repeated feedback from the physiotherapists. Adequate coping strategies for restoring and sustaining activities are taught and trained. Parents are trained on how to support new behaviours.
- Applied skill acquisition The basic capabilities are put together in order to shape the more complex skills required when applying in target activities. Self- efficacy is reinforced by feedback from both the physiotherapists and parents.
- Generalisation This phase includes the generalisation of new, both physical and psychological skills to other, for the adolescent important, activities.
- Maintenance and relapse prevention This phase includes the identification of "risk situations", and recognition of how adolescents and parents can support positive behaviours further.
Patient follow-ups takes place immediately after completed intervention, after 6 months and after one year and two years after intervention in order to evaluate the long-term effect.
- Parents The treatment is based on earlier intervention program and includes; Information on pain and pain behaviours and parental impact on adolescent's pain behaviours. An individual intervention plan according to each teenager's problems is made. All parents will be trained on how to support new positive health behaviours.
- Conditions
- Pain
- Being tested
- Behavioural medicine treatment, Standard treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural medicine treatmentBehavioural
The behavioural medicine treatment program will include muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis and age appropriate interventions aimed to address the emotional and behavioural processes of pain.
Standard treatmentOther
Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis
| Study group | Role | What they receive |
|---|---|---|
| Behavioural medicine | Experimental | Not described Receives: Behavioral: Behavioural medicine treatment |
| Standard treatment | Active comparator | Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Disability Inventory
Functional Disability Inventory assesses children's self reported difficulties in physical and psychosocial functioning due to the child's physical health. FDI consists of 15 items describing limitations of activities during the past two weeks. Each item is scored on a 5-point (0-4) where a higher score indicates greater disability. The FDI has been reported to have a high validity and reliability and can be used for children and adolescents with recurrent and chronic pain.
Measured: 6 months, one year and 2 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Uppsala County Council, Sweden
- Investigators
- Anne Söderlund, Professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381263
- Sponsor's protocol ID
- Dnr 2010/047
- Status last verified
- May 2018
- First submitted
- 20 Dec 2010
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Evaluation and Cost Effectiveness of a Treatment Program With a Behavioural Medicine Approach for Adolescents With Persistent Pain.
- ClinicalTrials.gov ID
- NCT01381263
- Acronym / sponsor ID
- Dnr 2010/047
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Uppsala County Council, Sweden
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jun 2011 (estimated)
- 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.
Recurrent pain, such as headache, stomach pain and musculoskeletal pain is common in children and adolescents. Children and adolescents are reported to have restrictions in daily life activities, social contacts, and school attendance, and to have poorer academic skills and as well as an increased utilization of heath care services due to pain problems. The treatment approaches available today for teenagers with pain are often biological/physiological and little evidence for their effectiveness has been shown. It is urgent to try new interventions for pain problems in early ages in order to prevent disability, development of maladaptive coping strategies and to avoid negative impact on daily activities.
The optimal treatment regime for paediatric pain patients has been suggested to be cognitive behavioural approach integrated with physical therapy The aim of this project is to develop and evaluate in a randomized controlled trial a treatment program with a behavioural medicine approach (suitable to use in primary care or school based health care context) compared with standard treatment for adolescents with persistent pain problems. The aim is also to compare short and long-term costs for patients and for the health care system related to the two interventions, in order to determine strategies for future cost-effective care of children and adolescents experiencing recurrent pain.
Detailed description
Chronic or recurrent pain symptoms are widely studied and generally regarded as an important public health concern in adults. The prevalence of pain symptoms are reported to be as high as 25-30 % in children and adolescents. Children and adolescents are reported to have restrictions in daily life activities, social contacts, and school attendance, and to have poorer academic skills and as well as an increased utilization of heath care services due to pain problems. These patients suffer from a wide variety of problems, for example sports injuries, persistent postoperative pain, musculoskeletal pains, headaches or multiple recurrent pain problems. The treatments given today to adolescents are dealing with symptoms in a physical manner.
In this study participants will be recruited among adolescents referred to paediatric physiotherapy. The participants will be randomly allocated to either physiotherapy including standard treatment or a behavioural medicine treatment program. Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis.
The behavioural medicine treatment program will include the same components as the standard treatment with the addition of age appropriate interventions aimed to address the emotional and behavioural processes of pain. The treatment is based on earlier intervention programs and includes the following phases;
- Individual functional behavioural analysis The adolescents lists specific important and frequent activities and situations they have problems to master due to pain and target activities are then chosen. Individual capabilities (both physical and psychological), behavioural responses, and their short and long-term consequences are identified. Parental responses and their impact on adolescent's pain behaviours are noted. Target activity related treatment goals as well goals for engagement in the treatment are defined from the individual functional behavioural analysis.
- Basic skill acquisition Physical abilities and cognitive skills required for improvement of behaviour in target activities are trained. For example to meet the problem of fear of movement, graded activity, or exposure will be provided. When negative thoughts are recognized the adolescents are taught and trained on how to replace these thoughts, self-efficacy for target activities are increased by carefully selected activities witch allows the adolescent to succeed and by repeated feedback from the physiotherapists. Adequate coping strategies for restoring and sustaining activities are taught and trained. Parents are trained on how to support new behaviours.
- Applied skill acquisition The basic capabilities are put together in order to shape the more complex skills required when applying in target activities. Self- efficacy is reinforced by feedback from both the physiotherapists and parents.
- Generalisation This phase includes the generalisation of new, both physical and psychological skills to other, for the adolescent important, activities.
- Maintenance and relapse prevention This phase includes the identification of "risk situations", and recognition of how adolescents and parents can support positive behaviours further.
Patient follow-ups takes place immediately after completed intervention, after 6 months and after one year and two years after intervention in order to evaluate the long-term effect.
- Parents The treatment is based on earlier intervention program and includes; Information on pain and pain behaviours and parental impact on adolescent's pain behaviours. An individual intervention plan according to each teenager's problems is made. All parents will be trained on how to support new positive health behaviours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioural medicine | Experimental | Behavioral: Behavioural medicine treatment |
| Standard treatment | Active comparator | Other: Standard treatmentStandard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Adolescents with pain and interference of daily activities due to pain, referred to paediatric physiotherapy in a primary health setting will be included.
- Participants must understand written and oral Swedish and have had persistent pain for more than 6 weeks or recurrent pain more than once a week for over three months.
- The adolescents´ parents will be included in a brief intervention.
Key exclusion criteria (1 listed)
- Subjects with resent trauma, ongoing treatment for any psychiatric illness or cognitive problems will be excluded.
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 |
|---|---|---|
| Behavioural medicine treatmentThe behavioural medicine treatment program will include muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis and age appropriate interventions aimed to address the emotional and behavioural processes of pain. | Behavioural | Behavioural medicine |
| Standard treatmentStandard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis | Other | Standard treatment |
Primary outcome
Change in Functional Disability Inventory
Time frame: 6 months, one year and 2 years post treatment
Functional Disability Inventory assesses children's self reported difficulties in physical and psychosocial functioning due to the child's physical health. FDI consists of 15 items describing limitations of activities during the past two weeks. Each item is scored on a 5-point (0-4) where a higher score indicates greater disability. The FDI has been reported to have a high validity and reliability and can be used for children and adolescents with recurrent and chronic pain.
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 25 May 2018.
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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.
Anne Söderlund, Professor principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural medicine treatment and Standard treatment in people with Pain, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 1 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 25 May 2018. 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 Sweden. 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?
Change in Functional Disability Inventory (time frame: 6 months, one year and 2 years post treatment). 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 25 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.