Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain (TLF-MFR-LBP)
2026年6月23日 更新者：Manahil Nisar、University of Health Sciences Lahore
Effects of Myofascial Release Targeting the Thoracolumbar Fascia on Fascial Morphology, Functional Outcomes, and Pain Self-Efficacy in Adults With Chronic Non-Specific Low Back Pain: A Randomized Controlled Trial
The thoracolumbar fascia (TLF) is thickened and stiffer in individuals with chronic non-specific low back pain (CNSLBP) and may contribute to pain persistence.
Myofascial release (MFR) has been shown to reduce TLF stiffness acutely; however, its longer-term effects on fascial morphology and pain self-efficacy remain unclear.
This randomized controlled trial will investigate the effects of a standardized 6-week MFR program targeting the thoracolumbar fascia compared with sham MFR in adults with CNSLBP.
A total of 65 participants aged 18-60 years with CNSLBP will be randomized in a 1:1 ratio to either standardized MFR or sham MFR.
The intervention will consist of 18 treatment sessions delivered over 6 weeks.
Primary outcomes include thoracolumbar fascia thickness measured by B-mode ultrasound, thoracolumbar fascia stiffness measured by shear-wave elastography, and pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ).
Secondary outcomes include pain intensity, functional disability, lumbar flexion range of motion, and patient global impression of change.
Outcomes will be assessed at baseline and after completion of the 6-week intervention period.
調査の概要
状態
まだ募集していません
条件
詳細な説明
Chronic non-specific low back pain (CNSLBP) is associated with structural and mechanical alterations of the thoracolumbar fascia (TLF), including increased thickness and stiffness. These changes may contribute to persistent pain and functional limitations. Myofascial release (MFR) is a manual therapy intervention designed to improve fascial mobility and reduce tissue stiffness; however, its effects on TLF morphology and related clinical outcomes remain incompletely understood.
This randomized controlled trial will evaluate the effects of a standardized 6-week myofascial release program targeting the thoracolumbar fascia in adults with chronic non-specific low back pain. Participants will be randomly assigned in a 1:1 ratio to either a myofascial release group or a sham myofascial release group.
Primary outcomes include thoracolumbar fascia thickness measured using B-mode ultrasound, thoracolumbar fascia stiffness measured using shear-wave elastography, and pain self-efficacy measured using the Pain Self-Efficacy Questionnaire. Secondary outcomes include pain intensity, disability, lumbar flexion range of motion, and patient global impression of change. Assessments will be performed at baseline and after completion of the 6-week intervention period.
The study aims to determine whether targeted myofascial release can modify thoracolumbar fascia morphology and improve clinical and psychosocial outcomes in individuals with chronic non-specific low back pain.
研究の種類
介入
入学 (推定)
65
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
- 名前：Manahil Nisar, DPT
- 電話番号：03240691766
- メール：dr.manahilnisar@gmail.com
研究場所
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Punjab Province
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Lahore、Punjab Province、パキスタン
- Affiliated Teaching Hospitals of University of Health Sciences Lahore
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コンタクト：
- Manahil Nisar, DPT
- メール：dr.manahilnisar@gmail.com
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コンタクト：
-
主任研究者：
- Manahil Nisar, DPT
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-
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:
- Adults aged 18-60 years
- Non-specific low back pain duration > 12 weeks
- Average pain intensity NRS ≥ 3 over the past week
- Able to provide written informed consent
- Able to attend 18 supervised sessions over 6 weeks (3 sessions/week)
Exclusion Criteria:
- Specific spinal pathology (fracture, disc herniation with neurological deficit, spinal stenosis, inflammatory arthropathy, malignancy)
- Previous lumbar surgery
- Current pregnancy
- Severe psychiatric disorder or active psychosis
- Manual therapy or physiotherapy for LBP within the previous 3 months
- Systemic connective tissue disorder (e.g., Ehlers-Danlos syndrome, Marfan syndrome)
- Contraindication to ultrasound imaging or manual therapy.
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 |
|---|---|
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実験的：Myofascial Release Group
Participants in this group will receive standardized myofascial release targeting the thoracolumbar fascia.
The intervention will consist of 18 sessions over 6 weeks (3 sessions per week), each lasting approximately 40 minutes.
The technique involves sustained low-load manual pressure using a crossed-hands approach applied to bilateral L2-L3 and L4-L5 regions of the thoracolumbar fascia.
Treatment will be delivered by a trained physiotherapist following a standardized protocol.
No additional physiotherapy interventions will be provided during the study period
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Standardized myofascial release targeting the thoracolumbar fascia will be administered over 18 sessions across 6 weeks (3 sessions per week).
Each session will last approximately 40 minutes and will involve sustained low-load manual pressure using a crossed-hands technique applied bilaterally at L2-L3 and L4-L5 regions.
The intervention aims to reduce fascial stiffness and improve tissue mobility.
Treatment will be delivered by a trained physiotherapist following a standardized protocol.
No additional physiotherapy interventions will be provided during the study period
他の名前：
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偽コンパレータ：Sham Myofascial Release Group
Participants in this group will receive sham myofascial release targeting the same anatomical regions as the experimental group.
Light manual contact (<50 g force) will be applied without therapeutic pressure or fascial engagement.
The session duration and frequency will be identical to the experimental group (18 sessions over 6 weeks, 3 sessions per week, approximately 40 minutes per session).
Participants will receive identical positioning and therapist contact time to control for placebo and attention effects.
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Sham myofascial release will be applied over the same anatomical regions as the experimental group using light manual contact (<50 g force) without therapeutic pressure or fascial engagement.
Sessions will be matched in duration (approximately 40 minutes), frequency (3 sessions per week), and total duration (6 weeks, 18 sessions).
The aim is to control for placebo effects, therapist attention, and patient expectation
他の名前：
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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 |
|---|---|---|
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Thoracolumbar Fascia Thickness
時間枠：Baseline and 6 weeks
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Change in thoracolumbar fascia thickness measured using B-mode ultrasound imaging
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Baseline and 6 weeks
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Thoracolumbar Fascia Stiffness
時間枠：Baseline and 6 weeks
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Change in thoracolumbar fascia stiffness measured using shear-wave Sonoelastography.
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Baseline and 6 weeks
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Pain Self-Efficacy (PSEQ)
時間枠：Baseline and 6 weeks
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Change in pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ), a 10-item questionnaire assessing confidence in performing activities despite pain.
Total scores range from 0 to 60, with higher scores indicating better pain self-efficacy (greater confidence in functioning despite pain).
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Baseline and 6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Intensity (Numeric Rating Scale)
時間枠：Baseline and 6 weeks
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Change in pain intensity measured using the 11-point Numeric Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
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Baseline and 6 weeks
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Lumbar Flexion Range of Motion
時間枠：Baseline and 6 weeks
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Change in lumbar flexion range of motion measured using the Modified Schober Test.
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Baseline and 6 weeks
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Functional Disability (Oswestry Disability Index)
時間枠：Baseline and 6 weeks
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Functional disability will be assessed using the Oswestry Disability Index (ODI).
Total scores range from 0 to 100, with higher scores indicating greater disability (worse functional status)
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Baseline and 6 weeks
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Patient Global Impression of Change (PGIC)
時間枠：6 weeks
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Participant-reported overall perception of improvement following the intervention, assessed using the Patient Global Impression of Change (PGIC) scale.
The PGIC is a 7-point scale ranging from 1 to 7, where 1 = very much worse and 7 = very much improved.
Higher scores indicate greater perceived improvement and a better outcome
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6 weeks
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研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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6月20日
一次修了 (推定)
2026年8月1日
研究の完了 (推定)
2026年8月1日
試験登録日
最初に提出
2026年6月18日
QC基準を満たした最初の提出物
2026年6月18日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月26日
QC基準を満たした最後の更新が送信されました
2026年6月23日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared.
Data will be retained by the investigators and institution in accordance with ethical and confidentiality requirements
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