Assessment of efficacy and safety of FIRTECH patch for treatment of acute mild-to-moderate low back pain: A phase 3 randomized clinical trial

Introduction

Low back pain (LBP) has the highest prevalence among musculoskeletal conditions affecting approximately 619 million people worldwide and stands as the primary cause of disability on a global scale¹. Non-pharmacological therapies are recommended as the first line of treatment for LBP², various guidelines including Danish, US and UK support the use of exercise as monotherapy or as multimodal approach in combination with other non-pharmacological therapies^3,4. FIRTECH is a non-pharmacological infrared (IR) patch containing bioceramic particles that harness the body’s natural heat and re-emit the IR energy. This energy can penetrate the skin and provide beneficial effects, such as antioxidative, anti-inflammatory, and tissue vasodilatory effects^5,6. This trial investigated the efficacy and safety of FIRTECH patch in the management of acute mild-to-moderate LBP.

Methods

In this open-label trial (NCT05137041), patients with acute mild-to-moderate LBP (<1M duration, intensity ≤6 on 0-10 Numerical Rating Scale [ NRS ]) were randomized to either FIRTECH patch or no-patch control arm (Fig 1). The patch was applied on Day1 (baseline) and removed on Day5. Primary endpoint: NRS responder rate at Day 5 by no difference (between group) hypothesis using Fisher’s exact test. Secondary endpoints: Normalized Sum of Pain Intensity Difference over 5 days (SPID_0-5); change from baseline to Day 5 in Roland-Morris Disability Questionnaire (RMDQ) score, mobility evaluation (Schöber’s Test), time to reach acceptable pain (TTAP), time to reach no pain (TTNP), time course of pain intensity difference (PID) and time course of pain relief; normalized sum of total pain relief over 5 days (TOTPAR_0-5) and safety. Descriptive and inferential analyses were used.

Results

Among 221 randomized subjects (FIRTECH, n=113; no patch, n=108) of mean (SD) age 45.2 (12.97) years, 54.8% were female. NRS-responder rate was significantly higher in FIRTECH (72.5%) vs no-patch arm (49.4%; p=0.002) (Fig 2). Among non-responders, 3 (3.3%) subjects in FIRTECH and 14 (15.7%) in no-patch arms used rescue medication. The FIRTECH arm showed significant decrease in normalized SPID_0-5 vs no-patch arm (LSM difference [95% CI]: −0.5 [−0.82, −1.14]; p=0.015) (Fig 3). Mobility was improved in the FIRTECH arm for Schöber’s Test (1.0 [0.511, 1.581]; p<0.001). Change in RMDQ score, TTAP and TTNP were not significant. Time course of PID, time course of pain relief and TOTPAR_0-5 (LSM 1.5 vs 0.8) over 5 days demonstrated better pain relief for FIRTECH vs no-patch starting from Day1-evening. Treatment emergent adverse events were reported in 18 subjects in FIRTECH vs 7 in no-patch arm. 

Discussion and Conclusion

The phase 3 trial data demonstrated promising evidence on the effectiveness of FIRTECH patch in relieving pain and improving mobility in patients with LBP up to 5 days. Additionally, the FIRTECH patch demonstrated a favourable safety profile and was well-tolerated. These IR patches can be a potential non-pharmacological option in the management of musculoskeletal pain that may help physiotherapy to achieve functional improvement and avoid chronicity of pain through rapid pain relief and restoration of patient’s ability.

Funding

This study was funded by Sanofi.

REFERENCES

1. Low back pain. World Health Organization (available on Low back pain (who.int), accessed July 29, 2023).
2. McSwan J, et al. J Pain Res. 2021;14:2943–2958.
3. Shipton EA. Pain Ther. 2018;7:127–137.
4. Mobasheri A. J Pain Res. 2022;15:3479–3482.
5. Mori MM, et al. Acta Biomed. 2019;90(3):287-292.
6. Nunes RFH, et al. J Hum Kinet. 2019;70:135–144.

Rehabilitative Treatment through Telemonitoring in Patients with Facio-Scapulo-Humeral Dystrophy (FSHD)

Introduction

There is limited literature on rehabilitative treatment for facio-scapulo-humeral dystrophy (FSHD). Combined aerobic exercises with range of motion exercises have shown to be the most effective, while the outcomes of muscle strengthening exercises remain controversial [1;2]. This study aims to investigate the effectiveness and adherence of a remotely monitored rehabilitative program in patients with FSHD.

Methods

A multidisciplinary approach involving quantitative and qualitative data analysis was employed for this study. Bibliographic research was conducted on research portals such as Pubmed, Cochrane, and Google Scholar to gain comprehensive insights into the impact of rehabilitation and telemonitoring in FSHD.

Results

Patients at Policlinico Hospital of Milan, Ospedale Maggiore, Fondazione IRCCS Ca’ Granda diagnosed with FSHD, 18 years of age or older, and able to ambulate were recruited. Patients unable to ambulate and with comorbidities that might interfere with study outcomes were excluded. Recruited patients will be assessed by quality of life questionnaires and functional tests at the beginning and end of the study. Patients will be left with a card of aerobic exercises, resistance exercises and flexibility exercises to be performed 4 times a week for a total of 16 weeks. During the course of the weeks, 2 televisits will be performed to monitor exercise progress.

Discussion and Conclusion

So far eight adult patients with FSHD were recluted. The 16-week study involved remote visits to monitor exercise adherence.

Results have been collected up to the 2nd televisit. The work will be concluded with the analysis of the results.

REFERENCES

1. Tawil, R. (2018) «Facioscapulohumeral muscular dystrophy», Handbook of Clinical Neurology, 148, pagg. 541–548. doi: 10.1016/B978-0-444-64076-5.00035-1.
2. Voet, N. B. M. et al. (2019) «Strength training and aerobic exercise training for muscle disease», Cochrane Database of Systematic Reviews, 2019(12). doi: 10.1002/14651858.CD003907.pub5.

ACCEPTANCE AND COMMITMENT THERAPY (ACT) INFORMED PHYSIOTHERAPY PRACTICE IN NON-SPECIFIC CHRONIC LOW BACK PAIN (NSCLBP): A CASE-REPORT

Introduction

Non-specific chronic low back pain (NSCLBP) is a common condition and source of significant suffering, disability and healthcare costs¹.

In this case-report we show the results of a combined physiotherapy treatment with the third wave generation of Cognitive Behavioural Therapy (CBT), the Acceptance and Commitment Therapy (ACT)².

ACT has been shown to have positive effects in chronic pain³, and meta-analyses of ACT for chronic pain showed improvements in pain intensity, physical functioning, depression and anxiety, and quality of life (QoL)⁴.

Methods

48-year-old male industry worker with CLBP for one year.

Recently divorced, he lives with his young daughter.

His general health is fine and he enjoys cycling in the weekend.

One year ago at job during heavier work than usual, constant LBP (NRPS 5/10 at rest) spreading to the right buttock without legs’ irradiation. At MRI discal bulging from L3 to S1, without evidence of herniation.

He has continued to work (NRPS 8/10 at worst).

Aggravating factors: sitting and spine loading during lifting tasks.

Only rest reduces pain and no further neurological symptoms are present.

Psychosocial factors: worries and fear about job, guarding behaviours and notes of kinesiophobia. His sleep is disrupted because of pain.

PROMs (t0 – 6/12 follow-up): OMPSQ, RMDQ, FABQ, TSK, PSEQ and CPAQ as shown in the tables: [ A1 ]

Main request: “to get strategies to manage pain and to re-establish work capacity”.

Results

The diagnostic triage⁵ excluded red flags for serious pathologies⁶ and absence of neural findings tips for diagnosis of NSCLBP.

Under a dispositional framework^7,8 the clinical picture -persistent stage, pain features related to mechanical behaviour with nociceptive contribution⁹, psychosocial aspects of fear-avoidance behaviour¹⁰ about work capacity, kinesiophobia and low self-efficacy- can be depicted in a graph with arrows  showing the dispositions that tend towards manifestation and maintaining of the condition or that are preventive under a causal lens[ A2 ]

The vectorial model shows treatment goals at a glance¹¹; it lasted 6 months, in 9 sessions, with main goals:

# make sense of pain and disability¹²

# expose gradually to provocative movements¹³

# set therapeutic path in a narrative way¹⁴ through principles of ACT, to restore patient’s autonomy and foster self-management strategies[A3,4]

Discussion and Conclusion

After different and failed rehabilitation attempts, in our episode of care it has been possible to exclude serious pathologies – and through a causal dispositionalist framework that sets apart a person-centred approach – he has been able to recover his functional levels and implement a self-management^15,16 program that consent him to cope successfully with his complaint, under a shared clinical decision-making and personal empowerment lens. Further, be acquainted in ACT’s core principles, directly reduces avoidance and promotes openness, bringing the possibility to build present-focused awareness, and coordinate greater engagement in goal-oriented and values-based activities.

REFERENCES

1. Murray CJL. Lancet 2012.
2. Hayes SC. Behavior therapy 2004.
3. Hann KEJ, McCracken LM. J Context Behav Sci 2014.
4. Veehof MM. Pain 2011.
5. Bardin LD. Med J Aust 2017..
6. Finucane LM. J Orthop Sports Phys Ther 2020.
7. Anjum RL, Copeland S, Rocca E. Rethinking causality, complexity and evidence for the unique patient: A CauseHealth resource for healthcare professionals and the clinical encounter. Springer 2020.
8. Smart KM. Clin J Pain 2011.
9. Vlaeyen JWS. Pain 2016.
10. Lin I. Br J Sports Med 2020.
11. Low M. J Eval Clin Pract 2017.
12. Caneiro JP. Braz J Phys Ther 2021.
13. Caneiro JP. Phys Ther 2022.
14. Launer J. Narrative based practice in health and social care: conversations inviting change. 2018. Routledge, London.
15. Hutting N. J Orthop Sports Phys Ther 2019.
16. Hutting N. Musculoskelet Sci Pract 2022.

The efficacy of the smartphone App for the self-management of low back pain: a systematic review of randomized control trial

Introduction

Methods

Results

Discussion and Conclusion

REFERENCES

Du S, Hu L, Dong J, Xu G, Chen X, Jin S, Zhang H, Yin H. Self-management program for chronic low back pain: A systematic review and meta-analysis. Patient Educ Couns. 2017 Jan;100(1):37-49. doi:10.1016/j.pec.2016.07.029.  PMID: 27554077.

Harnessing the Mind-Body Connection: Exploring the Therapeutic Potential of Motor Imagery for Foot Pain Relie

Introduction

Motor imagery, the cognitive process of mentally simulating movements without physical execution, has been widely studied in various contexts, including rehabilitation, sports performance, and pain management. It involves activating the same neural networks as actual movement and has shown potential benefits in enhancing motor learning, motor performance, and functional recovery[ 1 ]. In the realm of pain, motor imagery has gained attention as a potential therapeutic approach for individuals experiencing foot pain[ 2 ]. Understanding the relationship between motor imagery and foot pain is crucial for developing effective rehabilitation strategies and optimizing pain management approaches.

Methods

This review examines relevant articles [3,4] that investigate motor imagery in the context of foot pain. The studies encompass participants with different foot pain conditions, including leg amputation, chronic leg pain, complex regional pain syndrome, and Achilles tendinopathy. Various methodologies were employed to assess motor imagery abilities, including motor cortical mapping, foot laterality recognition tasks, EEG recordings, and treatment interventions incorporating motor imagery.

Results

The findings reveal several important insights. Individuals with leg amputation displayed functional reorganization in upper-limb motor cortical maps, accompanied by a breakdown in the inhibitory relationship between foot and hand representations. Participants with chronic leg pain exhibited slower and less accurate performance on foot laterality recognition tasks compared to healthy controls. Complex regional pain syndrome patients demonstrated distinct motor imagery strategies and varied responses to first-person and third-person perspectives. EEG studies highlighted differences in brain activity during motor imagery tasks under pain-free and pain conditions. Treatment interventions incorporating motor imagery showed promising outcomes in improving functional outcomes and reducing pain levels.

Discussion and Conclusion

Motor imagery appears to play a significant role in foot pain conditions, although further research is needed to establish consistent evidence and understand the underlying mechanisms. The integration of motor imagery into rehabilitation and pain management approaches holds promise for optimizing treatment outcomes in individuals with foot pain. Future research should focus on standardizing motor imagery assessment protocols, identifying specific patient populations that may benefit most from motor imagery interventions, and exploring the long-term effects of motor imagery-based interventions. By advancing our understanding of motor imagery in the context of foot pain, healthcare professionals can develop targeted and effective strategies to improve functional outcomes and enhance the overall well-being of individuals with foot pain.

REFERENCES

[ 1 ]Cooper LA, Shepard RN. Mental transformations in the identification of left and right hands. J Exp Psychol Hum Percept Perform. 1975 Feb;104(1):48-56.

[ 2 ]Sekiyama K. Kinesthetic aspects of mental representations in the identification of left and right hands. Percept Psychophys. 1982 Aug;32(2):89-95.

[ 3 ]Marconi B, Koch G, Pecchioli C, Cavallari P, Caltagirone C. Breakdown of inhibitory effects induced by foot motor imagery on hand motor area in lower-limb amputees. Clin Neurophysiol. 2007 Nov;118(11):2468-78.

[ 4 ]Rio EK, Stanton TR, Wand BM, Debenham JR, Cook J, Catley MJ, Moseley GL, Butler P, Cheng K, Mallows AJ, Wilson MVB, Girdwood M. Implicit Motor Imagery of the Foot and Hand in People with Achilles Tendinopathy: A Left Right Judgement Study. Pain Med. 2021 Dec 11;22(12):2998-3007.

A case report: an individualized and “patient centered” neuromotor rehabilitation path in a context of severe disability

Introduction

Methods

Neuromotor rehabilitation consisted in treatments carried out in a therapeutic pool and gymnasium; it was based on exercises aimed to allow GF acquiring a stable upright station, strengthening the muscles of the lower limbs, and urging autonomous ambulation that would improve autonomy in performing ADLs and facilitation in social participation. Exercises offered in gymnasium stressed upright position without supports, with different podal support surfaces and walking with the tetrapod. The activities performed in the swimming pool consisted of Sit to Stand, jumping, leg beats and walking performed with unstable supports and obstacles to overcome during walking.

Results

During the year of individualized treatment, GF showed significant improvements in different motor skills. By the end of treatment, he was able to keep: the sitting position with excellent head and trunk control; in the transition from sitting to standing he required only minimal support as well as to keep standing position. The patient showed improvement in trunk control during ambulation, particularly in hydrokinesiotherapy although he needed reinforcement to improve the gait pattern and internalization of the correct sequence and coordination of moments.

Discussion and Conclusion

This case highlights that in persons with complex disability, individualized and tailored treatment proves to be the best tool for implementing an intervention that places the individual at the centre of his or her rehabilitation program in order to achieve functional motor results impacting patient’s quality of life. The neuromotor rehabilitation pathway on a bi-weekly basis is lacking to be able to achieve consolidated results in line with the set goals; certainly greater cooperation in stimulating the user’s motor autonomy by the educational figures of the Institute, with whom he spends more time, would reinforce the achievements made in the gym.

REFERENCES

“Proposte riabilitative nelle paralisi cerebrali infantili”, Adriano Ferrari, ed. Del Cerro 2003

“Elementi di riabilitazione nella disabilità plurima”, F. Marchionni et al., ed. Istituto Serafico 2006

“Riabilitazione in acqua. Esercizi terapeutici”, A. Broglio e V. Colucci, Edi. Ermes 2001

“Cerebral Palsy: An Overview”, Vitrikas, Dalton and Breis, 2020

“Sit-to-stand training for self-care and mobility in children with cerebral palsy: a randomized controlled trial”, Chaovalit et al. 2021

SHOULDER TENDINOPATHY FOR SITTING VOLLEYBALL ITALIAN NATIONAL TEAM: EFFICIENCY OF A TREATMENT COMBINED WITH TECARTHERAPY

Introduction

Shoulder tendinopathy is a pathology caused by a functional overload typical of the “overhead” athlete, indeed these sports present movements characterized by the search of a forced and repeated motion of the arms above the head (1). This problem is very frequent in Sitting Volleyball players, who also need to play in a sitting position (2). The correlated pain leads to a worsening of daily activities and a decline of sports performance (3).

There are studies in the literature that demonstrate the usefulness of Tecartherapy® for this pathology (4). The aim of this study is to verify the effectiveness of Tecartherapy® as an adjunctive therapy to classic motor rehabilitation, in order to identify a method of treating shoulder tendinopathy in players of the Sitting Volleyball national team with the aim of increase short-term results concerning the reduction of pain, the increase of the ROM of the shoulder and the improvement of the activities of daily life and sports.

Methods

10 players of the Italian men’s sitting volleyball team (2021/22 competitive season) were recruited, with lower limb amputation, clinical diagnosis of shoulder tendinopathy and with age ranging from 25 to 50 (Figure 1). The objectives of the present study is to verify the best treatment both in the short term and after two months. The players were randomly divided into two groups of 5 people. The “experimental group” underwent the physiotherapy treatment in combination with Tecartherapy®, while the “control group” underwent only the physiotherapy treatment. Both groups had 10 treatment sessions and were evaluated as follows: before starting the treatment (T0), in the middle of the treatment (T1), at the end of the treatment (T2) and finally a follow-up was carried out after two months ( T3). Outcome measures were: limb tests for the shoulder ROM measurement, the NRS scale, the SF-12 and the DASH questionnaires.

Results

In order to extend the results to a larger sample, we used the 99% confidence interval (Figure 2). The ROM results showed that both therapies had a positive response, more precisely the “experimental group” obtained a superior increase in the majority of movements (Figure 3). The results of the NRS scale showed that a decrease in pain symptoms was found in both groups. The results of the SF-12 show that the “experimental group” obtained a general improvement, while the “control group” increased the physical score but manifested a decrease in the mental component (Figure 4). The DASH results demonstrate that in both groups a lower perception of the degree of disability in the functional, occupational and sports fields was detected. Moreover, the reduction of the value in the workplace in the “experimental group” is of a notable entity.

Discussion and Conclusion

The values of the T1 and T3 evaluations were not included in the analysis as they showed no statistically significant or clinically relevant differences. It is legitimate to hypothesize, regarding the T3 values, that this can be attributed to the physical inactivity of the players in the month of August and, therefore, to the forced rest to which they were subjected. From this it can be deduced that both treatments are valid in maintaining the progress obtained. On the basis of the objectives and what is highlighted by the results, it is possible to state that the application of Tecartherapy® positively influences the reduction of pain and the increase of the ROM of the shoulder and, consequently, also the improvement of daily life and sports activities. As a future perspective, it would be recommended to expand the study population in order to verify the results obtained and to have a more defined framework for the treatment of shoulder tendinopathy.

REFERENCES

1. S. Brent Brotzman, M.D.; Kevin E. Wilk, P.T., La Riabilitazione in ortopedia, Excerpta Medica Italia Srl, S. Donato Milanese (Mi), 2004
2. Gaweł, E.; Zwierzchowska, A. Effect Of Compensatory Mechanisms On Postural Disturbances And Musculoskeletal Pain In Elite Sitting Volleyball Players: Preparation Of A Compensatory Intervention. Int. J. Environ. Res. Public Health 2021, 18, 10105. Https://Doi.Org/10.3390/Ijerph181910105
3. Zwierzchowska, A., Gawel, E., Celebanska, D. Et Al. Musculoskeletal Pain As The Effect Of Internal Compensatory Mechanisms On Structural And Functional Changes In Body Build And Posture In Elite Polish Sitting Volleyball Players. Bmc Sports Sci Med Rehabil 14, 49 (2022). Https://Doi.Org/10.1186/S13102-022-00439-9
4. Samuel Ribeiro, Bebiana Henriques, Ricardo Cardoso. The Effectiveness Of Tecar Therapy In Musculoskeletal Disorders. International Journal Of Public Health And Health Systems. Vol. 3, No. 5, 2018, Pp. 77-83.

Assessment of the spine kinematics during walking using the optoelectronics system: a pilot study in healthy people

Introduction

Today spinal disorders in children are very important and widely analyzed with several methods. However, understanding spine kinematics to improve treatment decisions and outcomes is still to be fully exploited [ 1 ]. Stereo-photogrammetric motion analysis in static and dynamic tasks is the gold standard method to assess the real functional limitation [ 2 ]. The functional evaluation of the spine during  gait is a growing research area, besides no standard protocols have been developed [ 3 ]. The aim of this study is to analyze the reliability of a new multifactorial analysis protocol of movement to assess the kinematics of   spine and its segments (lumbar spine, lower dorsal spine, upper dorsal spine) during   gait, on the three anatomical planes, in terms of intra and inter operator variability.

Methods

Healthy subjects, without a history of low back pain or spine related pathology and with age greater than 5 years were admitted to the study. The acquisition procedure use the Smart DX (BTS Bioengineering), and consisted in :

• positioning the markers (30) on the selected body landmarks,
• acquisition of Standing trial: the subject maintains the standing position for at least 5 seconds,
• acquisition of 5 Walking trials: for every trial the subject walks at his preferred speed, for 5 meters.

Every subject repeated 2 sessions with 2 different operators (20 walking trials for every subject). The data collected were elaborated to calculate the ROM of different spine segments, normalized on gait cycle. The interclass correlation coefficient (ICC) (two-way mixed effects model, absolute agreement, average measurements) was calculated, to assess the intra and inter reliability of the protocol.

Results

We assessed 4 healthy subjects: their age was 7.8 yrs, 26.1 yrs, 5.5 and 33.1 yrs (2 males and 3 females).We were able to quantify the spine angles in all the trials acquired. The normal distribution of data was confirmed (Shapiro-Wilk test p>0.5). The ICC values of the ROM of different spine segments assessed, about  intra operator and inter operator reliability, are showed in the figure 1 and figure 2. The ICC value  0.5 and 0.75 indicate moderate reliability, values between 0.75 and 0.9, indicate good reliability, and values greater than, 0.90 indicate excellent reliability [ 4 ].

Discussion and Conclusion

We were able to quantify spine angles in healthy subjects in 100% of the acquisitions. The preliminary data confirm that the protocol is reliable in term of intra and inter variability, indeed show good to excellent validation in most of the calculated angles. Further research with a large sample is required and ongoing to confirm these preliminary results. This study was supported by “5 per mille” funds for biomedical  research, in particular for the project “5×1000/2023 – Sviluppo di nuovi protocolli di valutazione funzionale multifattoriale e relativi indici per l’età pediatrica” awarded to Prof. Giuseppe Andreoni.

REFERENCES

[ 1 ]         R. Haddas, K. L. Ju, T. Belanger, and I. H. Lieberman, “The use of gait analysis in the assessment of patients afflicted with spinal disorders,” Eur. Spine J., vol. 27, no. 8, pp. 1712–1723, 2018, doi: 10.1007/s00586-018-5569-1.

[ 2 ]         A. Leardini, F. Biagi, C. Belvedere, and M. G. Benedetti, “Quantitative comparison of current models for trunk motion in human movement analysis,” Clin. Biomech., vol. 24, no. 7, pp. 542–550, 2009, doi: 10.1016/j.clinbiomech.2009.05.005.

[ 3 ]         S. Negrini et al., “Trunk motion analysis: A systematic review from a clinical and methodological perspective,” Eur. J. Phys. Rehabil. Med., vol. 52, no. 4, pp. 583–592, 2016.

[ 4 ]         T. K. Koo and M. Y. Li, “A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research,” J. Chiropr. Med., vol. 15, no. 2, pp. 155–163, Jun. 2016, doi: 10.1016/j.jcm.2016.02.012.