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

7 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

62

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ibrar Hussain, MPhil PT
  • Número de teléfono: 5 021-36629251
  • Correo electrónico: ibrar.21886@zu.edu.pk

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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

Experimental: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mobility
Periodo de tiempo: Baseline
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
Baseline
Mobility
Periodo de tiempo: 6 weeks
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
6 weeks
Mobility
Periodo de tiempo: 12 weeks
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
12 weeks
Flexibility
Periodo de tiempo: Baseline
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
Baseline
Flexibility
Periodo de tiempo: 6 weeks
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
6 weeks
Flexibility
Periodo de tiempo: 12 weeks
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
12 weeks
Pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de septiembre de 2026

Finalización primaria (Estimado)

15 de octubre de 2026

Finalización del estudio (Estimado)

15 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Publicado por primera vez (Actual)

4 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de septiembre de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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