NCT07803731

Brief Summary

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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Sep 2026Jan 2027

First Submitted

Initial submission to the registry

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

September 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

September 1, 2026

Last Update Submit

September 7, 2026

Conditions

Keywords

Sacroiliac join painPainMobilityFlexibilityPelvic PNFHigh velocity low amplitude thrustManipulation

Outcome Measures

Primary Outcomes (9)

  • Pain

    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

    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

    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

  • Mobility

    Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD

    Baseline

  • Mobility

    Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD

    6 weeks

  • Mobility

    Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD

    12 weeks

  • Flexibility

    Flexibility will be assess using the Sit to Reach Test among individuals with SIJD

    Baseline

  • Flexibility

    Flexibility will be assess using the Sit to Reach Test among individuals with SIJD

    6 weeks

  • Flexibility

    Flexibility will be assess using the Sit to Reach Test among individuals with SIJD

    12 weeks

Study Arms (2)

Pelvic PNF

EXPERIMENTAL

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

Other: Pelvic PNF

HVLA thrust

EXPERIMENTAL

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

Other: HVLA thrust

Interventions

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

Pelvic PNF

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

HVLA thrust

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ibrar Hussain, MPhil PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded regarding group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1: 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 Group 2: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 4, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

January 15, 2027

Last Updated

September 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share