- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07719699
Effects of Whole-Body Vibration and Pilates on Pain, Dynamic Balance, and Functional Performance in Chronic Non-Specific Low Back Pain
Effects of Whole-Body Vibraton and Pilates on Pain, Dynamic Balance, and Functional Performance in Chronic Non-Specific Low Back Pain
Chronic non-specific low back pain (CNSLBP) affects pain, balance, and functional ability. This randomized clinical trial aims to compare the effects of whole-body vibration (WBV) and Pilates, both combined with conventional physiotherapy, on pain, dynamic balance, and functional performance.
A total of 68 participants aged 18-40 years will be randomly assigned to either a WBV group or a Pilates group. Both groups will receive treatment three times per week for four weeks. Outcomes will be measured using the Visual Analog Scale (pain), Y-Balance Test (dynamic balance), and Progressive Isoinertial Lifting Evaluation (functional performance).
The results will help determine which intervention is more effective for managing CNSLBP and guide evidence-based rehabilitation practices.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Chronic non-specific low back pain (CNSLBP) is a highly prevalent musculoskeletal condition that significantly impairs pain levels, dynamic balance, and functional performance, leading to reduced mobility and quality of life. Although various rehabilitation strategies exist, uncertainty remains regarding the comparative effectiveness of different interventions, particularly between active exercise-based approaches and passive modalities.
Pilates is a widely used exercise therapy focusing on core stability, postural control, flexibility, and muscle coordination, and has demonstrated effectiveness in reducing pain and disability in individuals with CNSLBP. Whole-body vibration (WBV), on the other hand, is an emerging rehabilitation modality that utilizes mechanical vibrations to stimulate neuromuscular activation, potentially improving muscle strength, balance, and functional performance. However, most previous studies have combined WBV with exercise, making it difficult to isolate its independent effects.
This randomized clinical trial aims to directly compare the effects of whole-body vibration therapy and Pilates, both combined with conventional physiotherapy, on pain intensity, dynamic balance, and functional performance in patients with chronic non-specific low back pain.
A total of 68 participants aged 18-40 years with CNSLBP will be randomly allocated into two groups. Group A will receive whole-body vibration therapy along with conventional treatment, while Group B will receive Pilates exercises along with conventional treatment. Both interventions will be administered three times per week for four weeks.
Outcome measures will include pain intensity assessed using the Visual Analog Scale (VAS), dynamic balance assessed using the Y-Balance Test, and functional performance assessed using the Progressive Isoinertial Lifting Evaluation (PILE) test. Assessments will be conducted by a blinded outcome assessor to minimize bias.
The findings of this study will provide high-quality evidence regarding the comparative effectiveness of WBV and Pilates, particularly in relation to dynamic balance, an underexplored but clinically important outcome. This study will help inform evidence-based rehabilitation strategies and guide clinicians in selecting appropriate interventions for individuals with CNSLBP, especially for patients who may have limited tolerance for conventional exercise programs.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dr Mehwish Khalid, MSPT
- Telefonní číslo: 03324302282
- E-mail: mehwish.khalid@ubas.edu.pk
Studijní záloha kontaktů
- Jméno: Sameera Nadeem, DPT
- Telefonní číslo: 03084899169
- E-mail: sameeranadeem7894@gmail.com
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 53400
- Nábor
- Surraya Azeem waqf hospital
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Kontakt:
- Sajjad Ali Sajjad, Masters
- Telefonní číslo: 03347329370
- E-mail: Sajjad.ali@umt.edu.pk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Male and Female (18-40 years age)
- Pain lasting for more than 12 weeks(determined by patient history)
- Pain scores (VAS) ranging from 3 to 8 points
- Pain located between T12 and gluteal folds(determined via palpation)
- Not having attended Pilates for low back pain for atleast 6 months prior to enrollment
Exclusion Criteria:
- History of spinal surgery, fractures, tumors, infections, or inflammatory spinal disease.
- Pregnant or lactating( strongly contraindicated for whole body vibration due to potential fetal risk and pelvic instability)
- Radicular pain, nerve root compression or neurological deficits.
- Medical comorbidities (e.g cardiovascular, neurological, endocrine or metabolic disease)(5).
- Physical limitations (e.g. orthopedic or rheumatic diseases, muscular injury, fibromyalgia, or pain)that could affect their ability to perform the Pilate exercises.
- Participants whose weight exceeds 150kg ( that's the maximum weight bearing capacity for WBV)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Whole Body Vibration
Participants in this group will receive Whole Body Vibration training using a vibration platform.
Sessions will be conducted 3 times per week for 4 weeks, lasting approximately 20-30 minutes per session.
The protocol will include static and dynamic postures designed to activate lower and upper limb musculature, with incorporated upper limb movements and a 2:1 work-rest ratio
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Whole-body vibration therapy will be delivered using a side-alternating vibration platform under the supervision of a trained physiotherapist. The intervention will be performed 3 sessions per week for 4 weeks. Each session will last 30 minutes, consisting of 10 bouts of 2 minutes vibration followed by 1 minute rest. Vibration parameters will include a frequency of 18 Hz and an amplitude of 2 mm. Participants will maintain a static standing posture with slight knee flexion, slight lumbar lordosis, and head erect. No additional exercises will be performed on the platform to isolate the effect of vibration. Participants will wear socks during the intervention. All participants will also receive conventional physiotherapy, including: Transcutaneous Electrical Nerve Stimulation (TENS): 100 Hz frequency, 200 µs pulse duration, 10 minutes Joint mobilization: oscillations at 1-2 Hz applied for approximately 5 minutes to hypomobile or painful lumbar segments |
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Aktivní komparátor: Pilates
participants in this group will receive a supervised mat-based Pilates program conducted by a trained physiotherapist.
The intervention will be carried out 3 times per week for 4 weeks, with each session lasting approximately 30 minutes.
Exercises will focus on core stability, postural alignment, controlled breathing, and upper limb engagement, performed using an intermittent 2:1 work-rest ratio.
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Mat-based Pilates exercises will be performed under the supervision of a trained physiotherapist. The intervention will be conducted 3 sessions per week for 4 weeks, with each session lasting approximately 30 minutes, using a 2:1 work-rest ratio similar to the WBV group. The program will include: Diaphragmatic breathing: 2 min activity + 1 min rest The Hundred: 2 sets of 2 min with 30 sec rest Roll Up: 5 cycles (40 sec activity + 20 sec rest) Single Leg Circles: small and large circles (40 sec each + 20 sec rest), bilaterally Spine Stretch: 5 cycles (40 sec activity + 20 sec rest) Single Leg Stretch: 4 cycles (40 sec activity + 20 sec rest) Diaphragmatic breathing (cool-down): 2 min activity + 1 min rest Exercises will be performed at low to moderate intensity, focusing on core stabilization, breathing control, flexibility, and controlled movement. All participants will also receive conventional physiotherapy, including TENS (100 Hz, 200 µs, 10 minutes) and lumbar joint mobilizatio |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain intensity
Časové okno: Time Frame: Baseline and 4 weeks (post-intervention).
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Outcome Measure: Change in dynamic balance measured using the Y-Balance Test.
Description: Dynamic balance will be assessed using the Y-Balance Test.
Reach distances in the anterior, posteromedial, and posterolateral directions will be normalized to limb length, and a composite score (%) will be calculated.
Higher composite scores indicate better dynamic balance.
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Time Frame: Baseline and 4 weeks (post-intervention).
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Dynamic Balance
Časové okno: 4 weeks
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Dynamic balance will be assessed using the Y-Balance Test Composite Reach Distance, normalized to limb length. Composite scores range from 0% to 100%. Higher scores indicate better dynamic balance. Unit of Measure: Percent (%) |
4 weeks
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Functional performance
Časové okno: Time Frame: Baseline and 4 weeks (post-intervention).
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Outcome Measure: Change in functional performance measured using the Progressive Isoinertial Lifting Evaluation (PILE). Description: Functional performance will be assessed using the Progressive Isoinertial Lifting Evaluation (PILE), which measures lifting capacity during a standardized lifting task. The primary outcome will be the maximum weight lifted (kg) and the number of completed lifting stages. Higher values indicate better functional performance. |
Time Frame: Baseline and 4 weeks (post-intervention).
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Shoaib Waqas, Lahore University of Biological and Applied Sciences
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UBAS/ERB/26/04/014
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Start Date: De-identified individual participant data (IPD) along with supporting materials will be made available following publication of the main trial findings, anticipated around 12 months after the study concludes.
End Date: The data will be accessible for a period of 5 years from the commencement date to eligible researchers who provide a formal application and consent to the data use agreement.
Kritéria přístupu pro sdílení IPD
Start Date: De-identified individual participant data (IPD) along with supporting materials will be made available following publication of the main trial findings, anticipated around 12 months after the study concludes.
End Date: The data will be accessible for a period of 5 years from the commencement date to eligible researchers who provide a formal application and consent to the data use agreement.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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