- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07244913
Efekty terapeutyczne mobilizacji tkanek miękkich wspomaganej instrumentem w porównaniu z mobilizacją wspomaganą dźwiękiem w przewlekłym nieswoistym bólu dolnej części pleców (IASTM VS SASTM)
Terapeutyczne efekty mobilizacji tkanek miękkich wspomaganej instrumentami w porównaniu z mobilizacją wspomaganą dźwiękiem wśród pacjentów z przewlekłym niespecyficznym bólem dolnej części pleców
Chronic low back pain (CLBP) is the most common medical problem observed among musculoskeletal pain and spinal pain problems. It can reduce the movements due to muscular imbalances, decreased activity of daily living, and effects on health-related quality of life. It is the major cause of activity limitation, work absence, and reported clinical issues. Most of the cases of low back pain remained undiagnosed and received only symptomatic management.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
There is limited literature on advanced soft tissue release techniques provided by primary healthcare practitioners specific to low back pain. Some of the studies are based on soft tissue mobilization using a mechanically assisted method, but they have limited outcomes, acute effects, and small sample sizes, which limit their generalization. Further literature is limited in the comparison of IASTM and SASTM. Further, there are limited techniques that can facilitate practitioners to identify the restrictions.
Firstly, instrument-assisted soft tissue mobilization (IASTM), due to its body contour and shape, recognizes specific tissue lesions and restriction sites while targeting specific points rather than using manual methods that cover a larger contact area. Using the mechanotransduction phenomenon, its mechanical stimuli initiate biochemical signals that trigger cellular responses and ultimately functional improvement. Biomechanically, fascial elasticity, fascial stiffness, and viscosity absorb and distribute forces. While tissue hydration level is increased, that is compromised in chronic low back pain.
Secondly, sound-assisted soft tissue mobilization could be an intervention for treating musculoskeletal disorders. The SASTM technique has the potential to be a game-changer in pain management after IASTM. The sound decreases as adhesions are broken. While breakdown of scar tissue can be a facilitator for ease of movement patterns.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Arif Memorial Teaching Hospital
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Lahore, Punjab Province, Pakistan, 54000
- Re Active Physio Clinic Lahore.
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Pain between the inferior gluteal folds and the costal margins.
- Pain with a duration of a minimum of 24 weeks.
- Moderate to severe pain (>3) was measured using the Numeric Pain Rating Scale.
- Straight Leg raise Limited (hamstring tightness)
Exclusion Criteria:
- Pain in lower back with radiating/referring but limited to proximal legs
- Pain for the last 03 months and at least half of the days in the last six months.
- Presence of neurological problem/deficit/disease (e.g., nerve root compression, motor deficit, paresthesia) and lower limb symptoms.
- Presence of disease like Infection, tumors, spondylolisthesis grade II or higher, vertebral fractures, identifiable cause like endometriosis
- Medicine like immunosuppression or steroid medication;
- Spinal deformities
- History of severe rheumatic, orthopedic, or cardiovascular disease in the last three months before study participation.
- Previously diagnosed Osteoporosis
- SIJ dysfunction is evaluated by a positive compression test.
- BMI over 35.
- Skin allergy or hypersensitivity that can lead to skin irritation due to IASTM/SASTM tools.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Group A
Group A (IASTM + Conventional therapy) |
The IASTM technique contains a protocol for treatment that contains five components: i. Examination, ii. warm-up exercises 5 min iii. IASTM treatment (e.g., 30-60 seconds per session), iv. Post treatment stretching and strengthening, v. Icing (only when sub-acute inflammation is of concern). In conventional therapy, patients will be given an exercise program that will be targeted to low back muscles. This will be include three type of exercise focusing on stretching, strengthening and postural correction exercise.(Yana et al., 2024) |
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Eksperymentalny: Group B
Group B (SASTM + Conventional) |
In conventional therapy, patients will be given an exercise program that will be targeted to low back muscles. This will be include three type of exercise focusing on stretching, strengthening and postural correction exercise.(Yana et al., 2024) The therapist will apply sound instrument-assisted soft tissue mobilization (SASTM) with a convex plastic (Ceramic) tool (Beer JA, 2019). |
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Inny: Group C
Conventional therapy |
In conventional therapy, patients will be given an exercise program that will be targeted to low back muscles. This will be include three type of exercise focusing on stretching, strengthening and postural correction exercise.(Yana et al., 2024) |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pain Intensity
Ramy czasowe: Pain intensity will be noted at baseline ,after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.
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The pain will be assessed using Chronic Pain grading Scale (CPGS). |
Pain intensity will be noted at baseline ,after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.
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Flexibility
Ramy czasowe: The lumbar flexibility will be noted at basline after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.
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Modified-Modified Schober Test will be used to measure Lumbar flexibility. |
The lumbar flexibility will be noted at basline after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Function
Ramy czasowe: The functional movement screening will be noted at baseline, after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.
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Functional movement Screen (FMS) will be used. |
The functional movement screening will be noted at baseline, after the 2nd week, 3rd week, 4th week, and follow up will be taken at 2nd month, and after the 4th month post intervention.
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Disability
Ramy czasowe: Disability will be assessed before treatment, after the 2nd month, and 4th month post-intervention.
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Roland Morris Disability Index will be used to measure disability Index. |
Disability will be assessed before treatment, after the 2nd month, and 4th month post-intervention.
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Hamstring Flexibility
Ramy czasowe: Hamstring flexibility will be measured at basline, 2nd month, and after the 4th month post intervention.
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Active knee Extension Test will be used to assess hamstring Flexibility. |
Hamstring flexibility will be measured at basline, 2nd month, and after the 4th month post intervention.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pelvic obliquity
Ramy czasowe: The pelvic obliquity will be assessed before treatment, after 2nd month and 4th month post-intervention.
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Leg length difference will be measured as an indicator of pelvic obliquity. |
The pelvic obliquity will be assessed before treatment, after 2nd month and 4th month post-intervention.
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
- Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
- Ahmed UA, Maharaj SS, Van Oosterwijck J. Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial. Scand J Pain. 2021 Feb 24;21(3):495-511. doi: 10.1515/sjpain-2020-0133. Print 2021 Jul 27.
- Yilmaz Yelvar GD, Cirak Y, Dalkilinc M, Parlak Demir Y, Guner Z, Boydak A. Is physiotherapy integrated virtual walking effective on pain, function, and kinesiophobia in patients with non-specific low-back pain? Randomised controlled trial. Eur Spine J. 2017 Feb;26(2):538-545. doi: 10.1007/s00586-016-4892-7. Epub 2016 Dec 15.
- Markman JD, Czerniecka-Foxx K, Khalsa PS, Hayek SM, Asher AL, Loeser JD, Chou R. AAPT Diagnostic Criteria for Chronic Low Back Pain. J Pain. 2020 Nov-Dec;21(11-12):1138-1148. doi: 10.1016/j.jpain.2020.01.008. Epub 2020 Feb 6.
- Yana M, Gunes M, Simsek A, Apaydin AS, Akinci C, Ozmen T. The Effect of Graston Technique on Pain, Proprioception, Flexibility, and Disability in Patients with Chronic Non-specific Low Back Pain. Altern Ther Health Med. 2024 Apr;30(4):24-30.
- Cheatham SW, Kreiswirth E, Baker R. Does a light pressure instrument assisted soft tissue mobilization technique modulate tactile discrimination and perceived pain in healthy individuals with DOMS? J Can Chiropr Assoc. 2019 Apr;63(1):18-25.
- Brandl A, Egner C, Schwarze M, Reer R, Schmidt T, Schleip R. Immediate Effects of Instrument-Assisted Soft Tissue Mobilization on Hydration Content in Lumbar Myofascial Tissues: A Quasi-Experiment. J Clin Med. 2023 Jan 28;12(3):1009. doi: 10.3390/jcm12031009.
- Brandl A, Egner C, Reer R, Schmidt T, Schleip R. Associations between Deformation of the Thoracolumbar Fascia and Activation of the Erector Spinae and Multifidus Muscle in Patients with Acute Low Back Pain and Healthy Controls: A Matched Pair Case-Control Study. Life (Basel). 2022 Oct 28;12(11):1735. doi: 10.3390/life12111735.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- UOL/IREB/25/12/0015
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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