- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07803731
Comparative Effects of Pelvic PNF and HVLA Thrust in Sacroiliac Joint Dysfunction (HVLA in SIJD)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ibrar Hussain, MPhil PT
- Telefoonnummer: 5 021-36629251
- E-mail: ibrar.21886@zu.edu.pk
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Clinically diagnosed participants with SIJD, referred by Orthopedics through five provocation and motion palpation test with age between 18 to 40 years.
- Baseline Pain > 4/10cm on VAS.
- Pain Duration > 4weeks.
Exclusion Criteria:
- Pregnancy and postpartum females.
- Pain score >8/10cm on VAS.
- Diagnosed cases of acute disc hernia and spinal stenosis that may cause pain in the lower back and hips, piriformis syndrome.
- True Leg Length Discrepancy or other structural deformities.
- Recent spinal/hip joint/lower limb Surgery < 3 months..
- Received Spinal Injections or Manual therapy for the sacroiliac joint < 3months.
- Diagnosed with Active Infection. Malignancy, metabolic disease, uncontrolled hypertension.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mobility
Tijdsspanne: Baseline
|
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
|
Baseline
|
|
Mobility
Tijdsspanne: 6 weeks
|
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
|
6 weeks
|
|
Mobility
Tijdsspanne: 12 weeks
|
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
|
12 weeks
|
|
Flexibility
Tijdsspanne: Baseline
|
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
|
Baseline
|
|
Flexibility
Tijdsspanne: 6 weeks
|
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
|
6 weeks
|
|
Flexibility
Tijdsspanne: 12 weeks
|
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
|
12 weeks
|
|
Pain
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Agarwal S, Bedekar N, Shyam A, Sancheti P. Comparison between effects of instrument-assisted soft tissue mobilization and manual myofascial release on pain, range of motion and function in myofascial pain syndrome of upper trapezius - A randomized controlled trial. Hong Kong Physiother J. 2024 Jun;44(1):57-67. doi: 10.1142/S1013702524500069. Epub 2023 Oct 26.
- Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
- Castro-Sanchez AM, Gil-Martinez E, Fernandez-Sanchez M, Lara-Palomo IC, Nastasia I, de Los Angeles Querol-Zaldivar M, Aguilar-Ferrandiz ME. Manipulative therapy of sacral torsion versus myofascial release in patients clinically diagnosed posterior pelvic pain: a consort compliant randomized controlled trial. Spine J. 2021 Nov;21(11):1890-1899. doi: 10.1016/j.spinee.2021.05.002. Epub 2021 May 13.
- Buchanan P, Vodapally S, Lee DW, Hagedorn JM, Bovinet C, Strand N, Sayed D, Deer T. Successful Diagnosis of Sacroiliac Joint Dysfunction. J Pain Res. 2021 Oct 8;14:3135-3143. doi: 10.2147/JPR.S327351. eCollection 2021.
- Trager RJ, Baumann AN, Rogers H, Tidd J, Orellana K, Preston G, Baldwin K. Efficacy of manual therapy for sacroiliac joint pain syndrome: a systematic review and meta-analysis of randomized controlled trials. J Man Manip Ther. 2024 Dec;32(6):561-572. doi: 10.1080/10669817.2024.2316420. Epub 2024 Feb 14.
- Amjad F, Mohseni Bandpei MA, Gilani SA, Arooj A. Reliability of modified-modified Schober's test for the assessment of lumbar range of motion. J Pak Med Assoc. 2022 Sep;72(9):1755-1759. doi: 10.47391/JPMA.4071.
- Alqhtani RS, Ahmed H, Alshahrani A, Alyami AM, Khan AR, Khan A. Synergistic Benefits of Motor Control Exercises and Balance Training in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial. Life (Basel). 2023 Nov 27;13(12):2258. doi: 10.3390/life13122258.
- Abdollahi S, Sheikhhoseini R, Rahimi M, Huddleston WE. The sacroiliac dysfunction and pain is associated with history of lower extremity sport related injuries. BMC Sports Sci Med Rehabil. 2023 Mar 20;15(1):36. doi: 10.1186/s13102-023-00648-w.
- Javadov A, Ketenci A, Aksoy C. The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome. Pain Physician. 2021 May;24(3):223-233.
- Beyazit S, Kimyon G, Karazincir S. Assessment of Anatomical Variations in the Sacroiliac Joint Using Magnetic Resonance Imaging: A Retrospective Study of 840 Patients. Diagnostics (Basel). 2026 Mar 28;16(7):1020. doi: 10.3390/diagnostics16071020.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12240326IHPT
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .