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

NCT05478200 | Recruiting

• 1 other identifier: 2
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain; Visual Impairment

Keywords

therapeutical exercise; Tele-assistance plattforms; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Oswestry Low Back Disability Questionnaire

  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 Outcomes (3)

• 30 seconds sit to stand

  immediately after the intervention

• Movement analysis with sensors

  immediately after the intervention

• Body build (approximate percentage of fat mass and muscle mass)

  immediately after the intervention

Study Arms (2)

Semi-directed Therapeutical Exercise and pain education program

EXPERIMENTAL

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

Pain release passive therapy based on manual therapy, thermotherapy and electroanalgesia

ACTIVE COMPARATOR

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

Interventions

physical exercise 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).

Also known as: education

Semi-directed Therapeutical Exercise and pain education program

Manual therapy 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).

Also known as: electrotherapy

Pain release passive therapy based on manual therapy, thermotherapy and electroanalgesia

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escuela Universitaria de Fisioterapia de la Once: lead
• Universidad de Zaragoza: collaborator

Study Sites (2)

Universidad de Zaragoza (Clínica Valdespartera y CS Seminario)

Zaragoza, Aragon, 50018, Spain

RECRUITING

Escuela Unviersitaria de Fisioterapia de la ONCE

Madrid, 28034, Spain

RECRUITING

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MeSH Terms

Conditions

Low Back Pain; Vision Disorders

Interventions

Exercise; Educational Status; Musculoskeletal Manipulations; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• João Sousa, MSc

  Escuela Universitaria de Fisioterapia de la Once

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Mota, MSc

CONTACT

(+34) 91 589 45 00; jmde@once.es

Juan Andrés Gonzalo, PhD

CONTACT

(+34) 91 589 45 00; jumago@once.es

Study Design

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

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 28, 2022
• Study Start: November 14, 2022
• Primary Completion: October 6, 2024
• Study Completion: December 15, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

ES (2)