---
title: Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain
nct_id: NCT04274439
overall_status: UNKNOWN
phase: NA
sponsor: Universidade Cidade de Sao Paulo
study_type: INTERVENTIONAL
primary_condition: Chronic Pain
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04274439.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04274439"
ct_last_update_post_date: 2020-03-26
last_seen_at: "2026-05-12T07:14:03.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain

**NCT ID:** [NCT04274439](https://clinicaltrials.gov/study/NCT04274439)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 160
- **Lead Sponsor:** Universidade Cidade de Sao Paulo
- **Collaborators:** Fundação de Amparo à Pesquisa do Estado de São Paulo
- **Conditions:** Chronic Pain
- **Start Date:** 2020-03-03
- **Completion Date:** 2022-03-10
- **CT.gov Last Update:** 2020-03-26

## Brief Summary

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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Internet-Based Pain Education and Exercise** (EXPERIMENTAL) — 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.
- **Online Booklet** (ACTIVE_COMPARATOR) — 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.

## Interventions

- **Internet-Based Pain Education and Exercise** (OTHER) — Telerehabilitation is defined as providing techniques for therapeutic rehabilitation remotely or off-site using telecommunication technologies. Thus, our intervention will be based on the use of a website created and registered especially for the study that will have the shooting of 1 video of pain education and 1 video of exercises for the subjects of the study, totaling 8 videos of pain education and 8 exercise videos. We will provide complimentary materials along with the triggered videos and a booklet of chronic pain information. We will also make weekly calls for a health coaching service and the sending of smartphone messages for the motivation and accountability of the subjects.
- **Online Booklet** (OTHER) — An online booklet containing information about chronic pain and suggestions for lifestyle modifications and behavior will be delivered, as well as an incentive to perform physical exercises.

## Primary Outcomes

- **Pain Intensity at post-treatment follow-up** _(time frame: Post-treatment follow-up (8 weeks))_ — The primary outcome will be pain intensity measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.

## Secondary Outcomes

- **Pain intensity at 6 months and 12 months follow-up** _(time frame: 6 months and 12 months follow-up)_
- **Function** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_
- **Health-Related Quality of Life** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_
- **Kinesiophobia** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_
- **Global Perceived Effect** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_
- **Anxiety and Depression** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_
- **Pain Catastrophisation** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_
- **Pain-related Attitudes and Beliefs** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_
- **Self-efficacy** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_
- **Adverse Effects** _(time frame: The outcome will be evaluated after the treatment period (8 weeks), after 6 months of randomization and after 12 months of randomization of each subject.)_

## Locations (1)

- Rua Cesário Galeno, 448/475, São Paulo, Brazil — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.rua cesário galeno, 448/475|são paulo||brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04274439.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04274439*  
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