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

NCT ID: NCT05478200

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2024-12-15

Brief Summary

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.

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.

Conditions

Low Back Pain; Visual Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

physical exercise

Intervention Type: BEHAVIORAL

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).

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.

Group Type: ACTIVE_COMPARATOR

Manual therapy

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: BEHAVIORAL

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).

Intervention Type: OTHER

Other Intervention Names

education; electrotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Escuela Universitaria de Fisioterapia de la Once

OTHER

Sponsor Role: lead

Responsible Party

Juan Andrés Martín Gonzalo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

João Sousa, MSc

Role: PRINCIPAL_INVESTIGATOR

Escuela Universitaria de Fisioterapia de la Once

Locations

Universidad de Zaragoza (Clínica Valdespartera y CS Seminario)

Zaragoza, Aragon, Spain

Site Status: RECRUITING

Escuela Unviersitaria de Fisioterapia de la ONCE

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

João Mota, MSc

Role: CONTACT

jmde@once.es

(+34) 91 589 45 00

Juan Andrés Gonzalo, PhD

Role: CONTACT

jumago@once.es

(+34) 91 589 45 00

Facility Contacts

Pablo Herrero, PhD

Role: primary

ph.herrero@unizar.es

Pablo Herrero, PhD

Role: backup

Joao Mota, msc

Role: primary

jmde@once.es

915894500 ext. 104388

Juan ANdrés Martín, PhD

Role: backup

jumago@once.es

915894500 ext. 104400

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Other Identifiers

2

Identifier Type: -

Identifier Source: org_study_id