Internet-based Cognitive Behavioral Therapy and Physiotherapy in Persons With Chronic Widespread Pain

NCT04624139 | Completed

• 1 other identifier: Painstress2020
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 4

Brief Summary

Objectives: To investigate the effect on pain of a stress reducing treatment that combine Internet based cognitive behavioral therapy (I-CBT) and physiotherapy in persons with chronic widespread pain (CWP) and to examine factors predicting potential improvement. Methods: 200 persons with CWP will be recruited from different parts of Region Västra Götaland (VGR) in Sweden, and randomized into two groups. Group 1: Combined intervention of stress reducing I-CBT and Physiotherapy. Group 2: Physiotherapy only. The participants complete a battery of questionnaires of symptoms and health related aspects at baseline, 6, 12 and 24 months. Interventions will take place at local rehabilitation centers in VGR.

Conditions

Pain, Chronic; Widespread Chronic Pain

Keywords

cognitive behavioral therapy; physiotherapy; widespread chronic pain; internet-based intervention

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  The subscale for pain intensity included in the Fibromyalgia Impact Questionnaire (FIQ) is used. The subscale is a visual analogue scale (VAS) (0-100 mm) on which the participant rate their pain intensity during the previous week, ranging from 0 (No pain) to 100 (Very severe pain). The outcome is assessed both on group level as change in pain intensity over time between the groups and on an individual level as proportions of participants in each group who have achieved moderate (≥30%) and major (≥50%) change in pain intensity.

  Change from baseline to 6 months, 12 months and 24 months.

• Pain spread

  The participants will state their painful areas in a pain drawing with 18 predefined body areas. The score range from 0 to 18.

  Change from baseline to 6 months, 12 months and 24 months.

Secondary Outcomes (6)

• The Stress and Crisis Inventory (SCI-93)

  Change from baseline to 6 months, 12 months and 24 months.

• The Leisure Time Physical Therapy Instrument (LTPAI)

  Change from baseline to 6 months, 12 months and 24 months.

• Fatigue

  Change from baseline to 6 months, 12 months and 24 months.

• Research and development (RAND)-36

  Change from baseline to 6 months, 12 months and 24 months.

• The Hospital Anxiety and Depression Scale (HADS)

  Change from baseline to 6 months, 12 months and 24 months.

Study Arms (2)

Intervention, group 1

EXPERIMENTAL

Combined intervention of stress reducing I-CBT and physiotherapy.

Behavioral: Internet-based cognitive behavioral therapy + physiotherapy

Active control group, group 2

ACTIVE COMPARATOR

Physiotherapy only

Behavioral: Physiotherapy only

Interventions

Internet-based cognitive behavioral therapy + physiotherapy BEHAVIORAL

Combined intervention of stress reducing I-CBT and physiotherapy. The intervention consists of two components; I-CBT and physiotherapy aiming to reduce symptoms of stress. I-CBT: Designed to reduce stress, during 8 weeks. Physiotherapy: A total of three visits with a physiotherapist (at start, after 4 weeks and after 12 weeks). Visit 1 (at start): The participant and the physiotherapist design together an individual plan of physical activity, based on the recommendations for stress as suggested in the Physical Activity in the Prevention and Treatment of Disease (FYSS in Swedish): Physical activity on moderate intensity 150 min/week and a strengthening exercise program performed at twice a week. The physical activity is performed outside health care - in the participant´s home or in other exercise premises outside health care Visit 2 and 3 (after 4 and 12 weeks): Follow up and revision of the Physical activity plan.

Intervention, group 1

Physiotherapy only BEHAVIORAL

A total of three visits with a physiotherapist (at start, after 4 weeks and after 12 weeks). Visit 1 (at start): The participant and the physiotherapist design together an individual plan of physical activity, based on the recommendations for stress as suggested in the Physical Activity in the Prevention and Treatment of Disease (FYSS in Swedish): Physical activity on moderate intensity 150 min/week and a strengthening exercise program performed at twice a week. The physical activity is performed outside health care - in the participant´s home or in other exercise premises outside health care Visit 2 and 3 (after 4 and 12 weeks): Follow up and revision of the Physical activity plan.

Active control group, group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men 18-70 years of age in VGR, fulfilling the criteria for CWP according to American College of Rheumatology 1990 criteria.
• Sufficient knowledge of Swedish language

You may not qualify if:

• Specific reasons for the pain, e g fracture or surgery in relation to the pain during the last 6 months.
• Not having a smart phone or computer
• Serious physical or psychological disease, such as Schizophrenia, stroke, ongoing cancer or other condition with restrictions of physical activity.
• Score \>15 on the subscale for anxiety or depression in the Hospital anxiety and depression scale (HADS): the participant will be advised to make an appointment with a psychologist.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (4)

Närhälsan Eriksberg Rehabmottagning

Gothenburg, Sweden

Location

Närhälsan Sannegården Rehabmottagning

Gothenburg, Sweden

Location

Närhälsan Lidköping Rehabmottagning

Lidköping, Sweden

Location

Närhälsan Uddevalla Rehabmottagning

Uddevalla, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Anna Bergenheim, PhD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: November 4, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

SE (4)