Behavioral Medicine Treatment for Adolescents in Pain

NCT01381263 | Completed DMC

• 1 other identifier: Dnr 2010/047
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months, one year and 2 years post treatment

Study Arms (2)

Behavioural medicine

EXPERIMENTAL

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

Other: Standard treatment

Interventions

Behavioural medicine treatment BEHAVIORAL

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.

Behavioural medicine

Standard treatment OTHER

Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis

Standard treatment

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with resent trauma, ongoing treatment for any psychiatric illness or cognitive problems will be excluded.

Sponsors & Collaborators

• Uppsala University: lead
• The Swedish Research Council: collaborator
• Uppsala County Council, Sweden: collaborator

Study Sites (1)

Samariterhemmet

Uppsala, 75125, Sweden

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Söderlund, Professor

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: June 27, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 25, 2018

Record last verified: 2018-05

Locations

SE (1)