このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Feasibility Assessment of Neurophysiological Measurement in Veterans With LBP

2021年2月11日 更新者:University of Florida

CENTRAL MECHANISMS OF BODY BASED INTERVENTION FOR MUSCULOSKELETAL LOW BACK PAIN: Feasibility Assessment of Neurophysiological Measurement in Veterans With Low Back Pain

This is study testing the feasibility of collecting neurophysiological measures of outcome related to body-based interventions for low back pain. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the interventions. Participants will be randomly assigned to either spinal manipulation or therapeutic touch groups. Participants will attend two practice sessions prior to the first data collection. There will be two follow-up assessments.

調査の概要

詳細な説明

Participants will be enrolled from VA pain clinical at the North Florida/South George VA Medical Center.

The investigators will collect functional magnetic resonance imaging data of resting state and pain-related events (i.i. during thermal pain sensitivity testing, as well as psychophysical data to determine pain sensitivity. Pain sensitivity will be measured using thermal and mechanical stimuli. These data will be collected before and after the interventions, in addition to two follow-up sessions after intervention.

In addition, clinical measures of pain intensity in the low back, as well as trunk range of motion and strength will also be collected.

研究の種類

介入

入学 (実際)

3

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。

研究場所

    • Florida
      • Gainesville、Florida、アメリカ、32610-0154
        • University of Florida

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

18年~40年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • complaints of current back pain that they rate at least 40 on a 101-point numeric rating scale
  • Participants must able to understand written and spoken English

Exclusion Criteria:

  • currently receiving treatment for LBP or have received SMT for LBP in the past year
  • Quebec Task Force on Spinal Disorders (QTFSD) to identify patients with pre-existing nerve root compression, spinal stenosis, or post-surgery
  • any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches)
  • any contraindication to MRI

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:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Spinal manipulation
Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain . The SMT will be performed four times (two times on each side) in a 5-minute period. In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain . The SMT will be performed four times (two times on each side) in a 5-minute period. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
Both groups will receive an fMRI.
他の名前:
  • 機能的MRI
Both groups will receive an Pain Sensitivity Testing
Both groups will receive Questionnaires
Both groups will receive testing on physical impairment.
偽コンパレータ:Therapeutic touch
Participants in this group will lie prone. The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table. This group accounts for effects of time and personal contact. The amount of "hands-on" contact will be equivalent between groups. Both groups will be given the same verbal instructions regarding the techniques performed. In addition, the following will be performed: Functional MRI (fMRI), Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
Both groups will receive an fMRI.
他の名前:
  • 機能的MRI
Both groups will receive an Pain Sensitivity Testing
Both groups will receive Questionnaires
Both groups will receive testing on physical impairment.
Participants in this group will lie prone. The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table. This group accounts for effects of time and personal contact. The amount of "hands-on" contact will be equivalent between groups. Both groups will be given the same verbal instructions regarding the techniques performed. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.

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
fMRI during testing of pain changes from approximately Day 3 and Day 5
時間枠:Change from approximately Day 3 and Day 5
Change from approximately Day 3 and Day 5
fMRI during quite rest changes from approximately Day 3 and Day 5
時間枠:Change from approximately Day 3 and Day 5
Change from approximately Day 3 and Day 5
Pain Sensitivity Testing changes from Day 3, Day 4 and Day 5
時間枠:Change from Day 3, Day 4 and Day 5
This measure thermal threshold and tolerance using continuous heat stimulus delivered to the participants' dominant arm. The stimulus will start at 35°C and will be increased at a rate of 0.5°C with participants terminating the stimulus when the temperature reached pain threshold ("when the sensation first transitions from heat to pain") and tolerance ("when the sensation becomes so strong you want to remove it from your skin"). Threshold and tolerance measures will also be collected using mechanical pressure applied using a Fischer Dolorimeter. During Dolorimeter testing, force is slowly increased until the subject indicates that the sensation changes from pressure to pain.
Change from Day 3, Day 4 and Day 5

二次結果の測定

結果測定
メジャーの説明
時間枠
Pain Intensity
時間枠:Change from Day 3, Day 4 and Day 5
Pain visual analog scale is a 10cm long line. The line is anchored at one end with 'none' or 'not bad at all' and at the other with 'worst imaginable.' Participants are asked to rate their pain at rest by placing a mark along the 10cm line. Participants will also rate pain during active trunk range of motion using the same scale.
Change from Day 3, Day 4 and Day 5
McGill Pain Questionnaire-2
時間枠:Change from Day 3, Day 4 and Day 5
This is 22-item questionnaire that asks participants to describe the intensity of varies qualities of the pain that he or she is experiencing; for example, throbbing or itching.
Change from Day 3, Day 4 and Day 5
Physical Impairment
時間枠:Change from Day 3, Day 4 and Day 5
A physical impairment scale consists of 7 different examination procedures that assess lumbar and hip range of motion, muscle performance of trunk musculature, and response to palpation. Scores is 0 - 8, Range is 0 is no impairment and 8 is completely impaired.
Change from Day 3, Day 4 and Day 5
Oswestry Disability Questionnaire (ODQ)
時間枠:Change from Day 3, Day 4 and Day 5
The ODQ has a range of 0 (no disability due to back pain) to 100 (completely disabled due to back pain), so higher scores indicate higher disability from LBP.
Change from Day 3, Day 4 and Day 5

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。

スポンサー

捜査官

  • 主任研究者:Mark D Bishop, PhD、University of Florida

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

2015年2月1日

一次修了 (実際)

2017年5月1日

研究の完了 (実際)

2017年5月1日

試験登録日

最初に提出

2015年2月24日

QC基準を満たした最初の提出物

2015年2月24日

最初の投稿 (見積もり)

2015年3月2日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月15日

QC基準を満たした最後の更新が送信されました

2021年2月11日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB201300827-N
  • 3R01AT006334-02S1 (米国 NIH グラント/契約)

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

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。

腰痛の臨床試験

Spinal manipulationの臨床試験

3
購読する