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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000044592
受付番号 R000050933
科学的試験名
一般公開日(本登録希望日) 2021/06/19
最終更新日 2021/06/18

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Comparison between tele-rehabilitation and face to face rehabilitation in patients with chronic mechanical low back pain.
一般向け試験名略称/Acronym
Tele-rehabilitation and Chronic low back pain
科学的試験名/Scientific Title
Comparison between tele-rehabilitation and face to face rehabilitation in patients with chronic mechanical low back pain.
科学的試験名略称/Scientific Title:Acronym
Tele-rehabilitation and Chronic low back pain
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Chronic Low Back Pain
疾患区分1/Classification by specialty
内科学一般/Medicine in general 整形外科学/Orthopedics
リハビリテーション医学/Rehabilitation medicine
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To determine an efficient treatment protocol for rehabilitation of chronic low back pain patients with respect to pain and functional disability
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Numerical Rating Scale (NRS)and Modified Oswestry Low Back Pain Disability Questionnaire were used to measure Pain and Functional Disability at baseline, after 2 weeks and after 4 weeks of intervention
副次アウトカム評価項目/Key secondary outcomes
Modified Schober's Test was used to measure Mobility of the Lumbar Spine at baseline, after 2 weeks and after 4 weeks of intervention

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 試験参加者がブラインド化されている単盲検/Single blind -participants are blinded
コントロール/Control 用量対照/Dose comparison
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医療器具・機器/Device,equipment 手技/Maneuver
介入1/Interventions/Control_1
Face to Face conventional Therapy which included Exercises which were conducted under the supervision of a Physiotherapist 3 days a week, continued for 4 weeks. Exercises were progressed weekly.
介入2/Interventions/Control_2
Tele-rehabilitation which included Exercises which were conducted under the supervision of a Physiotherapist 3 days a week, continued for 4 weeks. Exercises were conducted remotely via Zoom cloud meeting app and were progressed weekly.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
50 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Patients with chronic mechanical low back pain reporting to the Physiotherapy Outpatient Department.
除外基準/Key exclusion criteria
Patients with severe pain with a score of 8 and above on Numerical Pain rating scale, Patients with acute low back pain, patients with any infective or inflammatory low back pain and patients with neurological dysfunction and recent injuries.
目標参加者数/Target sample size 40

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Vijaya
ミドルネーム
Krishnan
所属組織/Organization
MGM College of Physiotherapy
所属部署/Division name
Navi Mumbai
郵便番号/Zip code 400705
住所/Address
Sanpada, Navi Mumbai
電話/TEL 9920029213
Email/Email victoryv2@yahoo.co.in

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Vijaya
ミドルネーム
Krishnan
組織名/Organization
MGM College of Physiotherapy
部署名/Division name
Navi Mumbai
郵便番号/Zip code 400705
住所/Address
Sanpada, Navi Mumbai
電話/TEL 9920029213
試験のホームページURL/Homepage URL
Email/Email victoryv2@yahoo.co.in

実施責任組織/Sponsor
機関名/Institute その他 MGM College of Physiotherapy
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Nil
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization その他/Other
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
MGM College of Physiotherapy
住所/Address
Navi Mumbai
電話/Tel 9920029213
Email/Email victoryv2@yahoo.co.in

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 06 19

関連情報/Related information
プロトコル掲載URL/URL releasing protocol data available on request
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications -
組み入れ参加者数/Number of participants that the trial has enrolled 40
主な結果/Results
Both the protocols showed statistically significant improvement for both pain, mobility and functional disability. However, Tele-rehabilitation was more effective with respect to Pain and functional disability in patients with chronic low back pain
主な結果入力日/Results date posted
2021 06 18
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics
Chronic low back pain patients were randomly allocated to two with 20 patients in each group. Mean age was 32.52 with 15 males and 25 females
参加者の流れ/Participant flow
Participants gave written informed consent followed by screening with respect to inclusion/exclusion criteria and then allocated to two groups. They were recruited with intent to treat
有害事象/Adverse events
No adverse events were reported
評価項目/Outcome measures
Numerical Pain Rating Scale, Modified Oswestry Low Back Pain Disability Questionnaire and Modified Schober's Test
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2019 03 20
倫理委員会による承認日/Date of IRB
2019 04 28
登録・組入れ開始(予定)日/Anticipated trial start date
2019 08 26
フォロー終了(予定)日/Last follow-up date
2020 02 05
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2021 06 18
最終更新日/Last modified on
2021 06 18


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050933
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050933

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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