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

Low Back Pain Clinical Trial

— TeleEDxPhysio  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478200
• Other study ID #: 2
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: Escuela Universitaria de Fisioterapia de la Once
• Contact: João Mota, MSc
• Phone: (+34) 91 589 45 00
• Email: jmde[@]once.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 15, 2024
• Est. primary completion date: October 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Low Back Pain
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

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:
• 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).

Locations

Country	Name	City	State
Spain	Escuela Unviersitaria de Fisioterapia de la ONCE	Madrid
Spain	Universidad de Zaragoza (Clínica Valdespartera y CS Seminario)	Zaragoza	Aragón

Sponsors (2)

Lead Sponsor	Collaborator
Escuela Universitaria de Fisioterapia de la Once	Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

References & Publications (33)

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

Boren K, Conrey C, Le Coguic J, Paprocki L, Voight M, Robinson TK. Electromyographic analysis of gluteus medius and gluteus maximus during rehabilitation exercises. Int J Sports Phys Ther. 2011 Sep;6(3):206-23. — View Citation

Calatayud J, Colado JC, Martin F, Casana J, Jakobsen MD, Andersen LL. CORE MUSCLE ACTIVITY DURING THE CLEAN AND JERK LIFT WITH BARBELL VERSUS SANDBAGS AND WATER BAGS. Int J Sports Phys Ther. 2015 Nov;10(6):803-10. — View Citation

Clark DR, Lambert MI, Hunter AM. Muscle activation in the loaded free barbell squat: a brief review. J Strength Cond Res. 2012 Apr;26(4):1169-78. doi: 10.1519/JSC.0b013e31822d533d. — View Citation

Cochrane SK, Chen SH, Fitzgerald JD, Dodson JA, Fielding RA, King AC, McDermott MM, Manini TM, Marsh AP, Newman AB, Pahor M, Tudor-Locke C, Ambrosius WT, Buford TW; LIFE Study Research Group. Association of Accelerometry-Measured Physical Activity and Cardiovascular Events in Mobility-Limited Older Adults: The LIFE (Lifestyle Interventions and Independence for Elders) Study. J Am Heart Assoc. 2017 Dec 2;6(12):e007215. doi: 10.1161/JAHA.117.007215. — View Citation

Collins FS, Varmus H. A new initiative on precision medicine. N Engl J Med. 2015 Feb 26;372(9):793-5. doi: 10.1056/NEJMp1500523. Epub 2015 Jan 30. — View Citation

Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12. — View Citation

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. — View Citation

Dhahbi W, Chaabene H, Chaouachi A, Padulo J, G Behm D, Cochrane J, Burnett A, Chamari K. Kinetic analysis of push-up exercises: a systematic review with practical recommendations. Sports Biomech. 2022 Jan;21(1):1-40. doi: 10.1080/14763141.2018.1512149. Epub 2018 Oct 4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Freitas SR, Mendes B, Le Sant G, Andrade RJ, Nordez A, Milanovic Z. Can chronic stretching change the muscle-tendon mechanical properties? A review. Scand J Med Sci Sports. 2018 Mar;28(3):794-806. doi: 10.1111/sms.12957. Epub 2017 Oct 9. — View Citation

Garcia-Hermoso A, Cerrillo-Urbina AJ, Herrera-Valenzuela T, Cristi-Montero C, Saavedra JM, Martinez-Vizcaino V. Is high-intensity interval training more effective on improving cardiometabolic risk and aerobic capacity than other forms of exercise in overweight and obese youth? A meta-analysis. Obes Rev. 2016 Jun;17(6):531-40. doi: 10.1111/obr.12395. Epub 2016 Mar 7. — View Citation

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. — View Citation

Kahraman T, Ozcan Kahraman B, Salik Sengul Y, Kalemci O. Assessment of sit-to-stand movement in nonspecific low back pain: a comparison study for psychometric properties of field-based and laboratory-based methods. Int J Rehabil Res. 2016 Jun;39(2):165-70. doi: 10.1097/MRR.0000000000000164. — View Citation

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. — View Citation

Lorenzetti S, Ostermann M, Zeidler F, Zimmer P, Jentsch L, List R, Taylor WR, Schellenberg F. How to squat? Effects of various stance widths, foot placement angles and level of experience on knee, hip and trunk motion and loading. BMC Sports Sci Med Rehabil. 2018 Jul 17;10:14. doi: 10.1186/s13102-018-0103-7. eCollection 2018. Erratum In: BMC Sports Sci Med Rehabil. 2020 Jan 29;12:7. — View Citation

McGill SM, Cannon J, Andersen JT. Muscle activity and spine load during pulling exercises: influence of stable and labile contact surfaces and technique coaching. J Electromyogr Kinesiol. 2014 Oct;24(5):652-65. doi: 10.1016/j.jelekin.2014.06.002. Epub 2014 Jun 25. — View Citation

Morin JB, Samozino P. Interpreting Power-Force-Velocity Profiles for Individualized and Specific Training. Int J Sports Physiol Perform. 2016 Mar;11(2):267-72. doi: 10.1123/ijspp.2015-0638. Epub 2015 Dec 17. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ramos JS, Dalleck LC, Tjonna AE, Beetham KS, Coombes JS. The impact of high-intensity interval training versus moderate-intensity continuous training on vascular function: a systematic review and meta-analysis. Sports Med. 2015 May;45(5):679-92. doi: 10.1007/s40279-015-0321-z. — View Citation

Sahrmann S. THE HOW AND WHY OF THE MOVEMENT SYSTEM AS THE IDENTITY OF PHYSICAL THERAPY. Int J Sports Phys Ther. 2017 Nov;12(6):862-869. — View Citation

Smith BE, Hendrick P, Smith TO, Bateman M, Moffatt F, Rathleff MS, Selfe J, Logan P. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(23):1679-1687. doi: 10.1136/bjsports-2016-097383. Epub 2017 Jun 8. — View Citation

Snarr RL, Hallmark AV, Casey JC, Esco MR. Electromyographical Comparison of a Traditional, Suspension Device, and Towel Pull-Up. J Hum Kinet. 2017 Aug 1;58:5-13. doi: 10.1515/hukin-2017-0068. eCollection 2017 Sep. — View Citation

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. — View Citation

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. — View Citation

Tataryn N, Simas V, Catterall T, Furness J, Keogh JWL. Posterior-Chain Resistance Training Compared to General Exercise and Walking Programmes for the Treatment of Chronic Low Back Pain in the General Population: A Systematic Review and Meta-Analysis. Sports Med Open. 2021 Mar 8;7(1):17. doi: 10.1186/s40798-021-00306-w. — View Citation

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. — View Citation

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. Erratum In: Spine J. Aug 1;14(8):a18. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	immediately after the intervention
Secondary	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	immediately after the intervention
Secondary	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.	immediately after the intervention