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Low Back PainTeleEDxPhysioNCT05478200

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

A study testing physical exercise and Manual therapy in people with Low Back Pain and Visual Impairment, run by Escuela Universitaria de Fisioterapia de la Once at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain, Visual Impairment
What is being tested?
physical exercise and Manual therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
2 sitesSpain
Study dates
14 Nov 2022to 15 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

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

Spain2 sites, 2 recruiting
  • Escuela Unviersitaria de Fisioterapia de la ONCE

    Madrid, 28034

    Joao Mota, msc, 915894500 ext. 104388, jmde@once.es

    Juan ANdrés Martín, PhD, 915894500 ext. 104400, jumago@once.es

    Recruiting
  • Universidad de Zaragoza (Clínica Valdespartera y CS Seminario)

    Zaragoza, Aragon, 50018

    Pablo Herrero, PhD, ph.herrero@unizar.es

    Pablo Herrero, PhD

    Recruiting

Other trials in Spain

About this study

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.

Read the 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.

Being tested
physical exercise, Manual therapy
Keywords
therapeutical exercise, Tele-assistance plattforms, Clinical Trial
Medical subject headings
Low Back Pain, Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physical exerciseBehavioural

    Also called education

    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).

  • Manual therapyOther

    Also called electrotherapy

    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).

Study groups in NCT05478200
Study groupRoleWhat they receive
Semi-directed Therapeutical Exercise and pain education programExperimentalPatients 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).
Receives: Behavioral: physical exercise
Pain release passive therapy based on manual therapy, thermotherapy and electroanalgesiaActive comparatorPatients 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.
Receives: Other: Manual therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: immediately after the intervention

Secondary outcomes (3)
  1. 30 seconds sit to stand

    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.

    Measured: immediately after the intervention

  2. Movement analysis with sensors

    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

    Measured: immediately after the intervention

  3. Body build (approximate percentage of fat mass and muscle mass)

    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.

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start14 Nov 2022
  3. Primary completion6 Oct 2024 (estimated)
  4. Study completion15 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478200
Sponsor's protocol ID
2
Acronym
TeleEDxPhysio
Status last verified
Feb 2024
First submitted
20 Jul 2022
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • O'Sullivan P, Caneiro JP, O'Keeffe M, O'Sullivan K. Unraveling the Complexity of Low Back Pain. J Orthop Sports Phys Ther. 2016 Nov;46(11):932-937. doi: 10.2519/jospt.2016.0609.

    PubMed 27802794
  • Wertli MM, Rasmussen-Barr E, Weiser S, Bachmann LM, Brunner F. The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J. 2014 May 1;14(5):816-36.e4. doi: 10.1016/j.spinee.2013.09.036. Epub 2013 Oct 18.

    PubMed 24412032
  • Jonsdottir S, Ahmed H, Tomasson K, Carter B. Factors associated with chronic and acute back pain in Wales, a cross-sectional study. BMC Musculoskelet Disord. 2019 May 15;20(1):215. doi: 10.1186/s12891-019-2477-4.

    PubMed 31092222
  • Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010 Jun;10(6):514-29. doi: 10.1016/j.spinee.2010.03.032.

    PubMed 20494814
  • Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976). 2002 Mar 1;27(5):E109-20. doi: 10.1097/00007632-200203010-00017.

    PubMed 11880847
  • Farioli A, Mattioli S, Quaglieri A, Curti S, Violante FS, Coggon D. Musculoskeletal pain in Europe: the role of personal, occupational, and social risk factors. Scand J Work Environ Health. 2014 Jan;40(1):36-46. doi: 10.5271/sjweh.3381. Epub 2013 Sep 5.

    PubMed 24009006
  • Adams MA. Biomechanics of back pain. Acupunct Med. 2004 Dec;22(4):178-88. doi: 10.1136/aim.22.4.178.

    PubMed 15628775
  • Fayad F, Lefevre-Colau MM, Poiraudeau S, Fermanian J, Rannou F, Wlodyka Demaille S, Benyahya R, Revel M. [Chronicity, recurrence, and return to work in low back pain: common prognostic factors]. Ann Readapt Med Phys. 2004 May;47(4):179-89. doi: 10.1016/j.annrmp.2004.01.005. French.

    PubMed 15130717
  • Stevans JM, Delitto A, Khoja SS, Patterson CG, Smith CN, Schneider MJ, Freburger JK, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Friedman M, Beneciuk JM, George SZ, Saper RB. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021 Feb 1;4(2):e2037371. doi: 10.1001/jamanetworkopen.2020.37371.

    PubMed 33591367
  • Rahimi A, Arab AM, Nourbakhsh MR, Hosseini SM, Forghany S. Lower limb kinematics in individuals with chronic low back pain during walking. J Electromyogr Kinesiol. 2020 Apr;51:102404. doi: 10.1016/j.jelekin.2020.102404. Epub 2020 Feb 17.

    PubMed 32120055
  • O'Sullivan P. It's time for change with the management of non-specific chronic low back pain. Br J Sports Med. 2012 Mar;46(4):224-7. doi: 10.1136/bjsm.2010.081638. Epub 2011 Aug 4. No abstract available.

    PubMed 21821612
  • Kim B, Yim J. Core Stability and Hip Exercises Improve Physical Function and Activity in Patients with Non-Specific Low Back Pain: A Randomized Controlled Trial. Tohoku J Exp Med. 2020 Jul;251(3):193-206. doi: 10.1620/tjem.251.193.

    PubMed 32669487
  • Fischer SC, Calley DQ, Hollman JH. Effect of an Exercise Program That Includes Deadlifts on Low Back Pain. J Sport Rehabil. 2021 Feb 24;30(4):672-675. doi: 10.1123/jsr.2020-0324.

    PubMed 33626500
  • Tjosvoll SO, Mork PJ, Iversen VM, Rise MB, Fimland MS. Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study. BMC Sports Sci Med Rehabil. 2020 May 8;12:30. doi: 10.1186/s13102-020-00181-0. eCollection 2020.

    PubMed 32411374
  • Suh JH, Kim H, Jung GP, Ko JY, Ryu JS. The effect of lumbar stabilization and walking exercises on chronic low back pain: A randomized controlled trial. Medicine (Baltimore). 2019 Jun;98(26):e16173. doi: 10.1097/MD.0000000000016173.

    PubMed 31261549

Questions about this trial

What is this clinical trial studying?

A study testing physical exercise and Manual therapy in people with Low Back Pain and Visual Impairment, run by Escuela Universitaria de Fisioterapia de la Once at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact João Mota, MSc ((+34) 91 589 45 00, jmde@once.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Low Back Disability Questionnaire (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478200, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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