Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain

Universidade Cidade de Sao Paulo

Status: Unknown

Conditions: Chronic Pain

Treatments: Other: Online Booklet; Other: Internet-Based Pain Education and Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04274439

02892918.0.0000.8084

2016/24217-7 (Other Grant/Funding Number)

Details and patient eligibility

About

The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.

Full description

Chronic pain is a major burden on the individual and society. It is estimated that about one third of the adult population worldwide suffer from chronic pain, with higher prevalence rates reported for low-income countries. Internet-based self-management programs have grown with the development of new technologies and have been extensively used for delivering healthcare in many areas. However, there is still little research on the development and testing of remotely-delivered programs for the management of chronic musculoskeletal pain, especially in low and mid-income countries. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 18 and 60 years

• Seeking treatment for any chronic musculoskeletal pain of at least 3 points in a 0 to 10 Pain Numerical Rating Scale

• Able to read and understand Portuguese

• With internet access.

  • Chronic Pain will be defined as pain lasting more than 12 weeks.

Exclusion criteria

• Present neurological symptoms (nerve root compromise, or sensation deficits)

• Present serious spinal pathologies (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases)

• Present serious cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes)

• Recent orthopaedic surgery (over the last 12 months)

• Scheduled to undergo surgery in the next 6 months, or pregnancy

• If have any contraindication to exercise

  • We will perform a pre-screening for physical activity participation at baseline using the Physical Activity Readiness Questionnaire (PAR-Q) Portuguese version to rule out any contraindication to participate in physical activity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Internet-Based Pain Education and Exercise

Experimental group

Description:

Patients allocated to the intervention group will receive a login and password for individual access to the website designed for the study. The content of this intervention will include videos and animations based on pain education, physical activity promotion and general exercises. The pain education component will be based on the E-pain intervention developed by Reis et al (2017), which includes nine main features: (1) acceptance, (2 and 3) education about pain, (4) sleep hygiene, (5) recognizing stress and negative emotions, (6) increasing positive coping in lifestyle, (7) exercises, (8) communication and (9) relapse prevention. The exercise component will include general exercises aiming to improve strength, flexibility, control and coordination. Patients in this group will also receive weekly text messages and a health coaching over the telephone. The text messages will include information on the benefits of exercises, motivation, and positive messages about dealing with pain.

Treatment:

Other: Internet-Based Pain Education and Exercise

Online Booklet

Active Comparator group

Description:

The patients allocated to the control group will have access to an online booklet containing general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. They will also receive one phone call at week 4 and text messages once a week during the study period.

Treatment:

Other: Online Booklet