Measuring Reliability of Spine Mobilization in Low Back Pain
2026年5月11日 更新者：University of Kansas Medical Center
This observational study aims to learn how to measure joint motion and tissue response when pressure is applied to the back and examine how the nervous system responds to the applied pressure. This pressure or mobilization technique is a standard care but we currently do not have a method to measure this technique. Through this study, we hope to validate a tool that allows physical therapists to measure the pressure applied during spinal mobilization.
Participants will be asked to:
- Receive spinal mobilization
- Participate in pain threshold testing
- Answer questionnaires
調査の概要
状態
完了
介入・治療
研究の種類
観察的
入学 (実際)
50
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。
研究場所
-
-
Kansas
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Kansas City、Kansas、アメリカ、66103
- University of Kansas Medical Center
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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
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
A convenience sample of healthy subjects (faculty and students, n=25) and subjects with chronic low back pain (n=25) will be recruited from the KUMC campus.
Subjects will be excluded if they report lumbar bony or joint pathology (i.e.
osteoporosis, rheumatoid arthritis), lumbar/sacral deformities (i.e.
spondylolisthesis, spina bifida), spinal surgery, have BMI >30, or are pregnant.
説明
Inclusion Criteria:
- Healthy individuals without current or recent history (within 6 months) of low back pain
- 18-70 years of age
- BMI between 18.5-29.9
- Ability to read and understand English
- For those with chronic low back pain: 1) low back pain more than 3 months and 2) a minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
Exclusion Criteria:
- Any signs or symptoms of lumbar pathology (as reported by the participant during interview such as low back pain, or lower limb neurological signs)
- History of any spinal surgery
- Lumbar/sacral conditions reported by the subject such as spondylolithesis, spina bifida or spinal fracture
- Bony pathology such as osteoporosis or rheumatoid arthritis as reported by the participant
- Pregnancy
- Spine cancer
- BMI >30
- Unable to lay on stomach
- Resting blood pressure more than 160/90 mmHg
- Currently taking blood thinning medications
- Uncontrolled diabetes
- A medical exclusion from having blood pressure taken such as a peripheral neuropathy
- Low signal to noise ratio fNIRS signal during calibration/setup
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Healthy Participants
Spinal mobilization
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The application of manual pressure to stiff spinal segments to improve mobility and control pain.
|
|
Chronic Low Back Pain Participants
Spinal mobilization
|
The application of manual pressure to stiff spinal segments to improve mobility and control pain.
|
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 |
|---|---|---|
|
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.
時間枠：Change from Baseline (day1) to immediately post-treatment (day 1)
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The amount of joint motion for a given grade as measured by the laboratory methods and from the lumbar mobilization feedback system.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
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Applied forces as measured by the laboratory methods and lumbar mobilization feedback system
時間枠：Change from Baseline (day1) to immediately post-treatment (day 1)
|
The magnitude of force produced by the clinician for each grade as measured by the laboratory methods and lumbar mobilization feedback system
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
|
Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback system
時間枠：Change from Baseline (day1) to immediately post-treatment (day 1)
|
The degree of stiffness of the joint measured as measured by laboratory methods and the lumbar mobilization feedback system
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
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Change in muscle activation as measured by electromyography
時間枠：Change from Baseline (day1) to immediately post-treatment (day 1)
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Differences in recorded electromyography (EMG) activity before and after administration of the intervention
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Change from Baseline (day1) to immediately post-treatment (day 1)
|
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Change in pain threshold as measured by quantitative sensory testing.
時間枠：Change from Baseline (day1) to immediately post-treatment (day 1)
|
The following tests will be used to test sensation threshold before and after grade I - IV mobilization/clinician: pressure pain threshold, conditioned pain modulation, and temporal summation.
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Change from Baseline (day1) to immediately post-treatment (day 1)
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Brain functional connectivity as measured by functional near infrared spectroscopy
時間枠：Change from Baseline (day1) to immediately post-treatment (day 1)
|
Functional near infrared spectroscopy (fNIRS) is a portable, non-invasive, and inexpensive brain imaging method of monitoring cerebral hemodynamic activity.
|
Change from Baseline (day1) to immediately post-treatment (day 1)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
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 (実際)
2024年10月2日
一次修了 (実際)
2025年2月2日
研究の完了 (実際)
2025年2月2日
試験登録日
最初に提出
2025年5月12日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月13日
QC基準を満たした最後の更新が送信されました
2026年5月11日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。