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

2026年9月7日 更新者: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.

調査の概要

状態

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詳細な説明

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.

研究の種類

介入

入学 (推定)

62

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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

実験的: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mobility
時間枠:Baseline
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
Baseline
Mobility
時間枠:6 weeks
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
6 weeks
Mobility
時間枠:12 weeks
Mobility will be assess using Modified-Modified Schober Test among individuals with SIJD
12 weeks
Flexibility
時間枠:Baseline
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
Baseline
Flexibility
時間枠:6 weeks
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
6 weeks
Flexibility
時間枠:12 weeks
Flexibility will be assess using the Sit to Reach Test among individuals with SIJD
12 weeks
Pain
時間枠: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
時間枠: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
時間枠: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

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出版物と役立つリンク

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月15日

一次修了 (推定)

2026年10月15日

研究の完了 (推定)

2027年1月15日

試験登録日

最初に提出

2026年9月1日

QC基準を満たした最初の提出物

2026年9月1日

最初の投稿 (実際)

2026年9月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月10日

QC基準を満たした最後の更新が送信されました

2026年9月7日

最終確認日

2026年7月1日

詳しくは

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いいえ

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いいえ

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いいえ

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