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Comparative Effects of Pelvic PNF and HVLA Thrust in Sacroiliac Joint Dysfunction (HVLA in SIJD)

7 septembre 2026 mis à jour par: Ziauddin University

This study, titled "Comparative Effects of Pelvic PNF and HVLA Thrust on Pain, Mobility, and Flexibility in Sacroiliac Joint Dysfunction," is a single-blinded randomized clinical trial (RCT) designed to evaluate and compare the therapeutic efficacy of two widely used but never directly compared manual therapy interventions Pelvic Proprioceptive Neuromuscular Facilitation (PNF) and High-Velocity Low-Amplitude (HVLA) thrust manipulation in individuals diagnosed with sacroiliac joint dysfunction (SIJD), a musculoskeletal condition responsible for a substantial proportion of low back pain cases worldwide yet frequently under-recognized and inconsistently managed in clinical practice.

The trial will enroll a total of 62 participants, aged between 18 and 40 years, recruited from the rehabilitation departments of two collaborating institutions in Karachi, Pakistan Creek General Hospital and Dr. Ziauddin Hospital with the sample size derived through G*Power software at a 95% confidence interval and 80% statistical power, based on a reference study, and inflated by 20% to account for anticipated attrition.

Eligible participants will be clinically diagnosed with SIJD by an orthopedic surgeon using a cluster of provocation and motion palpation tests, and must present with a baseline pain intensity greater than 4/10 cm on the Visual Analog Scale (VAS) persisting for more than four weeks, while individuals who are pregnant or postpartum, report pain exceeding 8/10 cm on VAS, have diagnosed disc herniation, spinal stenosis, piriformis syndrome, true leg length discrepancy, recent spinal or lower-limb surgery, recent spinal injections or SIJ manual therapy, or active infection, malignancy, or uncontrolled hypertension will be excluded. Following informed written consent, participants will be randomly allocated through a sealed-envelope simple randomization technique into two equal groups of 31: Group A receiving Pelvic PNF, involving diagonal pelvic patterns such as anterior depression and posterior elevation combined with Rhythmic Stabilization and Contract-Relax Stretch techniques, and Group B receiving HVLA thrust manipulation, a controlled high-velocity, low-amplitude manual force applied directly to the sacroiliac joint. Baseline assessments, including demographic data (age, gender, height, weight, BMI, dominant and affected side) and outcome measures, will be conducted by a blinded, trained physiotherapist-assessor to minimize observer bias, with the three primary outcomespain intensity (via VAS), lumbo-pelvic mobility (via the Modified-Modified Schober Test), and posterior-chain flexibility (via the Sit and Reach Test) evaluated at three time points: baseline, six weeks post-intervention, and a twelve-week follow-up to determine the sustainability of treatment effects.

The overall trial duration is set at six months following synopsis approval, and data will be analyzed statistically to test the null hypothesis (that HVLA is superior to Pelvic PNF) against the alternative hypothesis (that Pelvic PNF is superior to HVLA). Ethically, the study will proceed only after formal institutional approval, with all participants providing voluntary informed consent after receiving a Patient Information Sheet and adequate time for consideration, ensuring compliance with standard human-subject research protections.

By generating the first direct, objectively measured comparison between these two conservative, non-pharmacological interventions, this trial aims to fill a clearly identified gap in the physiotherapy literature and provide clinicians with evidence-based guidance for selecting the more effective treatment approach in managing sacroiliac joint dysfunction, thereby improving conservative care pathways and clinical decision-making in orthopedic and physiotherapy practice.

Aperçu de l'étude

Statut

Pas encore de recrutement

Description détaillée

This study proposes a single-blinded randomized clinical trial comparing Pelvic Proprioceptive Neuromuscular Facilitation (PNF) and High-Velocity Low-Amplitude (HVLA) thrust for treating sacroiliac joint dysfunction (SIJD), a common but under-recognized cause of low back pain, aiming to determine which technique more effectively improves pain (via VAS), mobility (via Modified-Modified Schober Test), and flexibility (via Sit and Reach Test) when assessed at baseline, 6 weeks, and 12-week follow-up, since no prior study has directly compared these two widely used but separately studied interventions; the study will recruit 62 participants aged 18-40 with clinically diagnosed SIJD from two Karachi hospitals (Creek General Hospital and Dr. Ziauddin Hospital), randomly allocating them via sealed-envelope sampling into a Pelvic PNF group and an HVLA group over a six-month period, with the goal of generating direct comparative evidence to help physiotherapists make more precise, evidence-based decisions in managing this condition.

Type d'étude

Interventionnel

Inscription (Estimé)

62

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

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. Clinically diagnosed participants with SIJD, referred by Orthopedics through five provocation and motion palpation test with age between 18 to 40 years.
  2. Baseline Pain > 4/10cm on VAS.
  3. Pain Duration > 4weeks.

Exclusion Criteria:

  1. Pregnancy and postpartum females.
  2. Pain score >8/10cm on VAS.
  3. Diagnosed cases of acute disc hernia and spinal stenosis that may cause pain in the lower back and hips, piriformis syndrome.
  4. True Leg Length Discrepancy or other structural deformities.
  5. Recent spinal/hip joint/lower limb Surgery < 3 months..
  6. Received Spinal Injections or Manual therapy for the sacroiliac joint < 3months.
  7. Diagnosed with Active Infection. Malignancy, metabolic disease, uncontrolled hypertension.

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: Pelvic PNF

Anterior depression with rhythmic stabilization + posterior elevation with contract-relax stretch (side-lying position), preceded by a hot pack, plus the same SIJ exercises.

Dosage: 3 sets × 10-12 reps, 60-sec rest between sets, Frequency: 3 sessions/week, 45 min each, Duration: 6 weeks

Anterior depression with rhythmic stabilization + posterior elevation with contract-relax stretch (side-lying position), preceded by a hot pack, plus the same SIJ exercises.

Dosage: 3 sets × 10-12 reps, 60-sec rest between sets, Frequency: 3 sessions/week, 45 min each, Duration: 6 weeks

Expérimental: HVLA thrust

Single high-velocity low-amplitude thrust manipulation to the SI joint (supine position), preceded by a 10-min hot pack, plus SIJ exercises (Bridging, Cat-Camel, Piriformis, lumbar stretching, hip isometrics).

Dosage: 1 thrust/session, Frequency: 3 sessions/week, 45 min each, Duration: 6 weeks

Single high-velocity low-amplitude thrust manipulation to the SI joint (supine position), preceded by a 10-min hot pack, plus SIJ exercises (Bridging, Cat-Camel, Piriformis, lumbar stretching, hip isometrics).

Dosage: 1 thrust/session, Frequency: 3 sessions/week, 45 min each, Duration: 6 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mobility
Délai: Baseline
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
Baseline
Mobility
Délai: 6 weeks
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
6 weeks
Mobility
Délai: 12 weeks
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
12 weeks
Flexibility
Délai: Baseline
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
Baseline
Flexibility
Délai: 6 weeks
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
6 weeks
Flexibility
Délai: 12 weeks
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
12 weeks
Pain
Délai: Baseline.
Pain will be assess using Visual Analog Scale among individuals with SIJD, a 0-10 rating scale. where "0" indicates "no pain" and "10" indicates "worst pain".
Baseline.
Pain
Délai: 6 weeks
Pain will be assess using Visual Analog Scale among individuals with SIJD, a 0-10 rating scale. where "0" indicates "no pain" and "10" indicates "worst pain".
6 weeks
Pain
Délai: at 12 weeks
Pain will be assess using Visual Analog Scale among individuals with SIJD, a 0-10 rating scale. where "0" indicates "no pain" and "10" indicates "worst pain".
at 12 weeks

Collaborateurs et enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 (Estimé)

15 septembre 2026

Achèvement primaire (Estimé)

15 octobre 2026

Achèvement de l'étude (Estimé)

15 janvier 2027

Dates d'inscription aux études

Première soumission

1 septembre 2026

Première soumission répondant aux critères de contrôle qualité

1 septembre 2026

Première publication (Réel)

4 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 septembre 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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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

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