NCT Number: NCT07803731
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.
Trial opening soon.
Get Notified18 year–40 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Baseline.
Pain will be assess using VAS among individuals with SIJD
Time frame: 6 weeks
Pain will be assess using VAS among individuals with SIJD
Time frame: at 12 weeks
Pain will be assess using VAS among individuals with SIJD
Time frame: Baseline
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
Time frame: 6 weeks
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
Time frame: 12 weeks
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
Time frame: Baseline
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
Time frame: 6 weeks
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
Time frame: 12 weeks
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
Contact information is provided by the study sponsor or research team.
Ziauddin University
Other
Acronym: HVLA in SIJD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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