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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.

Aperçu de l'étude

Statut

Recrutement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

68

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 53400
        • Recrutement
        • Surraya Azeem waqf hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Male and Female (18-40 years age)
  2. Pain lasting for more than 12 weeks(determined by patient history)
  3. Pain scores (VAS) ranging from 3 to 8 points
  4. Pain located between T12 and gluteal folds(determined via palpation)
  5. Not having attended Pilates for low back pain for atleast 6 months prior to enrollment

Exclusion Criteria:

  1. History of spinal surgery, fractures, tumors, infections, or inflammatory spinal disease.
  2. Pregnant or lactating( strongly contraindicated for whole body vibration due to potential fetal risk and pelvic instability)
  3. Radicular pain, nerve root compression or neurological deficits.
  4. Medical comorbidities (e.g cardiovascular, neurological, endocrine or metabolic disease)(5).
  5. Physical limitations (e.g. orthopedic or rheumatic diseases, muscular injury, fibromyalgia, or pain)that could affect their ability to perform the Pilate exercises.
  6. Participants whose weight exceeds 150kg ( that's the maximum weight bearing capacity for WBV)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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

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

Comparateur actif: 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.

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pain intensity
Délai: Time Frame: Baseline and 4 weeks (post-intervention).
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.
Time Frame: Baseline and 4 weeks (post-intervention).
Dynamic Balance
Délai: 4 weeks

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
Functional performance
Délai: Time Frame: Baseline and 4 weeks (post-intervention).

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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chaise d'étude: Shoaib Waqas, Lahore University of Biological and Applied Sciences

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2026

Achèvement primaire (Réel)

30 juillet 2026

Achèvement de l'étude (Estimé)

15 septembre 2026

Dates d'inscription aux études

Première soumission

9 juillet 2026

Première soumission répondant aux critères de contrôle qualité

20 juillet 2026

Première publication (Réel)

22 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • UBAS/ERB/26/04/014

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

baseline participants

Délai de partage 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.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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