Development of a Tele-Physiotherapy Tool for the Early Management of Muskuloskeletal Pain in People With Visual Impairement (TeleEDxPhysio) (TeleEDxPhysio)

February 19, 2024 updated by: Juan Andrés Martín Gonzalo, Escuela Universitaria de Fisioterapia de la Once
Chronic NonSpecific Low Back Pain (CNSLBP) is a common musculoskeletal condition often resulting in physical inactivity and disability. CNSLBP is associated with a large number of social and health costs, being one of the most important health problems worldwide. Although Therapeutical Exercise (TE) has been shown to be effective in increasing physical activity tolerance, physical fitness, strength, self perceived quality of live, pain tolerance, and overall physical activity participation levels in persons with CNSLBP, pain-release-passive therapy modalities are significantly more commonly used in clinical settings at present. On the other hand, the use of tele-assistance platforms PTAs has been gaining importance in the treatment of CNSLBP patients, especially in the use of semi-directed TE programs. However, current PTAs are not accessible for the visually impaired, a group that is at greater risk of suffering from sedentary lifestyles, restricted mobility and musculoskeletal pain due to postural or gait changes. The main hypothesis of these study is that a semi-directed TE and health education programm, in people with and without visual impairment, achieves better results in movement capacity, functional recovery, strength and compared to passive analgesic treatment in patients with CNSLBP. In a second objective, we will assess the efficacy and usability of a new PTA accesible tool for the follow-up of patients with CNSLBP who are visually impaired.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION Chronic non-specific low back pain (CNSLBP) is self-defining, as it is a long-lasting low back pain for which the exact cause is unknown in most cases. CLBP is a disease that causes pain and disability). It has a high social impact, as it often causes unemployment and early retirement, representing a major threat and burden to health, society and the economy. CNSLBP is associated with a high burden of direct costs, such as treatment costs (consultations, hospitalisation, medication, diagnosis, and emergency services) as well as indirect costs (lost or reduced productivity, etc. It is estimated that 5% of chronic patients consume 75% of the total cost of care for this disease and it is one of the main causes of temporary disability and permanent disability. The total number of DALYs (number of years lost due to illness, disability) associated with CNSLBP in Europe amounts to 10,731,256.71 according to the 2019 global burden of disease study, and is expected to increase, especially in Western Europe. Currently, CNSLBP is considered a health priority, which does not directly impact on the risk of death but has a high impact on quality of life.

There are a myriad of therapeutic options for the treatment of CNSLBP. Undoubtedly, those that have demonstrated the best results are all active modalities. Therapy modalities with a more passive character also have a proven analgesic efficacy, but their effect does not last over time. Studies reveal similar effects when different active therapy modalities are compared, such as walking, Pilates, abdominal exercises, analytical or functional strength exercises, stretching, among others. However, to date, we have not found a protocol that integrates the best exercises of the different modalities in the optimal workloads.

HYPOTHESIS The hypothesis put forward in this project is that a programme based on semi-directed therapeutic exercise and health education, in people with and without visual impairment, achieves better results in movement capacity, functional capacity, strength and body constitution, compared to a treatment based on passive analgesic techniques, in patients with CNSLBP.

GENERAL AND SPECIFIC OBJECTIVES The overall objective of this project is to compare the impact of a semi-directed therapeutic exercise and health education programme in CLBP patients, with and without visual impairment, compared to passive analgesic treatment.

The specific objectives to be achieved are:

  1. To quantify the difference in scores on the OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE (ODI), between the group of patients receiving the exercise programme (group A) and the passive analgesic treatment (group B).

    The degree of disability generated by the CLBP will be compared in both groups at the beginning and at the end of the intervention. This will allow us to create a structured recommendation on the best intervention model for the treatment of these patients.

  2. Quantify what are the main differences in the movement pattern of the subjects in the active group (A) and the passive group (B).

    Significant differences, which we aim to objectify, are expected in terms of movement patterns, measured by sensors, after two opposite interventions.

  3. To identify differences in the results obtained with the different intervention modalities in subjects (participants) with and without visual impairment.

    It will be interesting to identify in each of the groups whether there are differences in terms of results in subjects with and without visual impairment, thus being able to establish visual impairment as a conditioning factor in the treatment process of these patients.

  4. To analyse adherence to treatment in both groups. Comparing the number of drop-outs in both groups, as well as the degree of compliance with the homework tasks (group A), would allow us to identify adherence to two totally opposite treatment modalities.
  5. To find the percentage of homework completion in the active group. As this is a semi-directed exercise programme, intervention group A, part of the tasks will be carried out without the presence of the physiotherapist. It will be interesting to understand what percentage of the subjects do or do not complete the home tasks, by means of activity monitoring devices.
  6. To identify difficulties in the understanding and execution of home sessions by visually impaired people. We know that even for people without visual impairment, the correct understanding of tasks at home can be extremely difficult. In this case, it will be possible to identify how the visual impairment interferes with this process by monitoring the patient on a weekly basis.

  7. To find out the individual effectiveness of the exercises selected in the programme.

    There is little evidence regarding the movements selected for strength work in CLBP patients. Some authors have successfully employed whole body functional work, abdominal stabilisation exercises, extensor chain strengthening exercises, gait; however, there is still a lack of work experimenting with these exercise modalities.

  8. Analyse the tools used in the study for the visually impaired user.

The patient with CNSLBP and visual impairment faces some challenges in accessing digital content. It will be important to understand whether or not the elements used are effective for this population.

All these objectives seek as a common interest the contribution of scientific evidence that supports the use of intelligent sensors in musculoskeletal pathology and that, integrated in telecare PTAs and through the use of artificial intelligence, allow the physiotherapist to be able to establish with greater precision a personalised diagnosis, as well as to serve patients as a feedback system that allows them to be an active part of their diagnosis and treatment.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: João Mota, MSc
  • Phone Number: (+34) 91 589 45 00
  • Email: jmde@once.es

Study Contact Backup

  • Name: Juan Andrés Gonzalo, PhD
  • Phone Number: (+34) 91 589 45 00
  • Email: jumago@once.es

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Recruiting
        • Escuela Unviersitaria de Fisioterapia de la ONCE
        • Contact:
          • Joao Mota, msc
          • Phone Number: 104388 915894500
          • Email: jmde@once.es
        • Contact:
          • Juan ANdrés Martín, PhD
          • Phone Number: 104400 915894500
          • Email: jumago@once.es
    • Aragón
      • Zaragoza, Aragón, Spain, 50018
        • Recruiting
        • Universidad de Zaragoza (Clínica Valdespartera y CS Seminario)
        • Contact:
        • Contact:
          • Pablo Herrero, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Suffer CNSLBP of 12 weeks or more evolution, whose pain location is mainly from T12 to the gluteal folds, with or without referred pain to the lower extremities.
  • Pain that is provoked and relieved by different positions, movements and activities. In other words, mechanical behaviour.
  • Low back pain whose movement behaviours have a clear association with their pain disorder.

Exclusion Criteria:

  • Presence of 1 or more red flags (any sign or symptom that warns of the possible presence of a serious medical condition that may cause irreversible disability or death if not treated appropriately).
  • Presence of non-specific low back pain of less than 12 weeks' duration.
  • Diagnosis of specific low back pain by a physician (radicular pain, herniated disc, spondylolisthesis, stenosis, etc.), any lower limb or lumbar spine surgery within the last 3 months, pregnancy, pain without clear mechanical behaviour, active rheumatological disease, progressive neurological disease, severe cardiac or other systemic medical condition, malignant disease, acute osteoarticular trauma, fractures, infections or acute vascular problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semi-directed Therapeutical Exercise and pain education program
Patients will receive physical exercise, combined with pain education and healthy lifestyle habits: an intervention programme consisting of 3 sessions per week for 12 weeks (total of 36 sessions). Each week there will be one face-to-face session, followed by 2 home sessions, (12 face-to-face and 24 home sessions). The sessions will include cardiovascular exercises, 2 days a week we will work on strength 13 and 1 day a week we will work on mobility and exercises to improve movement control, both before the cardiovascular effort14 . Each session will include a light warm-up (at the beginning of the session) and a cool down (at the end).
Behavioral: physical exercise
Group A (physical exercise, combined with pain education and healthy lifestyle habits), will receive an intervention programme consisting of 3 sessions per week for 12 weeks (total of 36 sessions). Each week there will be one face-to-face session, followed by 2 home sessions, (12 face-to-face and 24 home sessions). The sessions will include cardiovascular exercises, 2 days a week we will work on strength13 and 1 day a week we will work on mobility and exercises to improve movement control, both before the cardiovascular effort14 . Each session will include a light warm-up (at the beginning of the session) and a cool down (at the end).
Other Names:
  • education
Active Comparator: Pain release passive therapy based on manual therapy, thermotherapy and electroanalgesia

Patients will receive 35-40 minutes of passive analgesic techniques sessions (2 per week, over 8 weeks). The following treatment will be applied:

15 minutes of massage on the lumbopelvic musculature, lower lumbar segments and sacroiliac joints rhytmic-passive mobilization. The hip may also be mobilised at physiotherapist's discretion, 10 minutes of electrotherapy (interferential current in the lumbar region) Medium frequency current, interrupted alternating sinusoidal pulse with a frequency of up to 250 Hz and thermotherapy (10-15 minutes local in the lumbar region) with antenna electrodes placed at a distance of 20 cm from the patient's skin, at an intensity of 70 to 120 watts.
Other: Manual therapy
Group B will receive a treatment based on passive analgesic techniques consisting of manual therapy, electrotherapy (interferential currents) and thermotherapy (microwaves). This treatment will be carried out in two weekly sessions (over eight weeks) of 40 minutes each, consisting of 15 minutes of manual therapy (of the lumbopelvic musculature), 10 minutes of electrotherapy (interferential current in the lumbar region) and thermotherapy (10 minutes local in the lumbar region).
Other Names:
  • electrotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Low Back Disability Questionnaire
Time Frame: immediately after the intervention
ODI: this questionnaire has been designed to give information as to how the back pain has affected the ability to manage everyday life. The patient should choose between several options on a 10 questions questionnaire.
immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 seconds sit to stand
Time Frame: immediately after the intervention
This consists of sitting down and getting up from a chair (the same movement that we will analyse with the sensors), the maximum number of times during 30 seconds. This is a marker of general strength status.
immediately after the intervention
Movement analysis with sensors
Time Frame: immediately after the intervention
Ability to move during the simple gesture of getting up and sitting down five times from a chair as quickly as possible and leaning forward without bending the knees
immediately after the intervention
Body build (approximate percentage of fat mass and muscle mass)
Time Frame: immediately after the intervention
Bioimpedance analysis: a safe, inexpensive, accurate and non-invasive method that provides data on body composition (muscle mass, fat mass and water percentage). It consists of a very low intensity electric current that collects body tissues.
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escuela Universitaria de Fisioterapia de la Once

Collaborators

Universidad de Zaragoza

Investigators

  • Principal Investigator: João Sousa, MSc, Escuela Universitaria de Fisioterapia de la ONCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Estimated)

October 6, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain

Clinical Trials on physical exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe