Safety and Efficacy of MORA Cure LBP in Patients With Chronic Low Back Pain (MORACureLBP)
2026年6月17日 更新者：EverEx Inc.
A Prospective, Randomized, Open-label, Multicenter, Controlled, Comparative, Confirmatory Trial of MORA Cure in Patients With Chronic Low Back Pain: 8-week Evaluation and 12-week Follow-up
This is a prospective, randomized, open-label, multicenter, controlled, comparative, confirmatory clinical trial to evaluate the safety and efficacy of MORA Cure LBP, a multidisciplinary digital therapeutic, in patients with chronic low back pain.
Eligible participants will be randomized in a 1:1 ratio to either the experimental group using MORA Cure LBP or the control group receiving exercise education and self-exercise materials. The treatment period is 8 weeks, followed by a 4-week observation period, for a total study period of 12 weeks from baseline. The primary efficacy endpoint is usual low back pain intensity during the past week measured by the 11-point Numeric Pain Rating Scale at Week 8.
調査の概要
詳細な説明
MORA Cure LBP is a software-based digital therapeutic intended to improve symptoms in patients with chronic low back pain by providing app-based exercise therapy and cognitive behavioral therapy. The investigational medical device consists of a patient mobile application and a clinician web program. Through the clinician web program, investigators can prescribe rehabilitation programs and monitor participants.
Participants assigned to the experimental group will use MORA Cure LBP for 8 weeks. Use of the device at least 3 times per week is recommended. After the 8-week treatment period, participants may continue to use available content during the follow-up observation period through Week 12.
Participants assigned to the control group will receive disease education, self-exercise education, and self-exercise materials. They will perform self-exercise and record exercise performance in a self-exercise diary.
Participants will attend 3 to 5 visits, including screening, baseline, Week 4, Week 8, and Week 12. The Week 4 visit may be conducted as a televisit. The Week 8 visit is the primary evaluation time point, and the Week 12 visit is the follow-up evaluation time point.
研究の種類
介入
入学 (推定)
156
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
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Gyeonggi-do
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Guri-si、Gyeonggi-do、韓国
- Hanyang University Guri Hospital
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Gwangmyeong、Gyeonggi-do、韓国
- Chung-Ang University Gwangmyeong Hospital
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Uijeongbu-si、Gyeonggi-do、韓国
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
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Korea
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Seoul、Korea、韓国
- Seoul National University Hospital
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Seoul
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Seoul、Seoul、韓国
- Samsung Medical Center
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Seoul、Seoul、韓国
- Kangbuk Samsung Hospital
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Seoul、Seoul、韓国
- Nowon Eulji University Hospital
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Seoul、Seoul、韓国
- Seoul Asan Hospital
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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
いいえ
説明
Inclusion Criteria
- Adults aged 19 years or older.
- Participants with low back pain lasting for at least 12 weeks.
- Participants with average low back pain intensity of 4 or higher on the Numeric Pain Rating Scale.
- Participants who are able to undergo application-based treatment using a smartphone.
- Participants who voluntarily decide to participate in the clinical trial and sign the informed consent form before the start of the trial.
- Participants who, in the opinion of the principal investigator, are able to comply with the clinical investigation plan.
Exclusion Criteria
- History of previous spinal surgery.
- History of spinal injection treatment within 1 month before screening.
- History of spinal trauma within 3 months before screening.
- Lower limb muscle strength of 3 or less on manual muscle testing, or lower limb radiating pain accompanied by motor dysfunction.
- Grade 2 or higher spondylolisthesis on radiographic imaging.
- Scoliosis, defined as Cobb angle of 25 degrees or greater with a clear structural cause based on the principal investigator's judgment, or kyphosis, defined as lumbar lordosis angle less than 0 degrees.
- Red flag signs, such as paralysis symptoms including bladder or bowel dysfunction, or sudden unexplained weight loss.
- Tumor, infection, metabolic bone disease, cognitive impairment, fibromyalgia, systemic inflammatory disease, or systemic inflammatory disorder.
- Any other systemic or psychiatric condition that, in the opinion of the principal investigator, limits exercise therapy.
- Current use of opioid analgesics with potency equal to or greater than morphine for any other disease or low back pain, such as oxycodone, fentanyl, or pethidine. Participants may participate after a 14-day washout period if applicable.
- Pregnant participants, participants planning pregnancy during the clinical trial, or participants unable to maintain contraception during the clinical trial.
- Current participation in another clinical trial or planned participation in another clinical trial during this study.
- Inability to communicate, difficulty following instructions, or any other condition that, in the opinion of the principal investigator, makes the participant unsuitable for this clinical trial.
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：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 |
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実験的：MORA Cure Digital Therapeutic
Participants assigned to the experimental group will use MORA Cure, a software-based digital therapeutic consisting of a patient mobile application and clinician web program.
MORA Cure provides an 8-week app-based rehabilitation exercise program and cognitive behavioral therapy for chronic low back pain.
Participants are recommended to use the device at least 3 times per week.
After the 8-week treatment period, participants may use available content during the observation period through Week 12.
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MORA Cure is a digital therapeutic software intended to improve symptoms in patients with chronic low back pain by providing exercise therapy and cognitive behavioral therapy through a patient mobile application and clinician web program.
他の名前：
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アクティブコンパレータ：Exercise Education and Self-Exercise
Participants assigned to the control group will receive disease education, exercise education, and self-exercise materials.
Participants will perform self-exercise and record exercise performance in a self-exercise diary.
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Participants will receive education regarding chronic low back pain and self-exercise based on the control group exercise education materials.
Participants will perform self-exercise and record exercise performance in a self-exercise diary.
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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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Usual Low Back Pain Intensity at Weeks 4 and 12 Measured by the 11-point Numeric Pain Rating Scale
時間枠：Week 4 and Week 12 after baseline
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Usual low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups.
The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain intensity.
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Week 4 and Week 12 after baseline
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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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Worst Low Back Pain Intensity at Weeks 4, 8, and 12 Measured by the 11-point Numeric Pain Rating Scale
時間枠：Week 4, Week 8, and Week 12 after baseline
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Worst low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups.
The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain intensity.
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Week 4, Week 8, and Week 12 after baseline
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Worst low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups. The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the wor
時間枠：Week 4, Week 8, and Week 12 after baseline
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Worst low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups.
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Week 4, Week 8, and Week 12 after baseline
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Functional Disability at Weeks 4, 8, and 12 Measured by the Oswestry Disability Index
時間枠：Week 4, Week 8, and Week 12 after baseline
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Functional disability related to low back pain will be assessed using the Oswestry Disability Index and compared between groups.
The Oswestry Disability Index score ranges from 0 to 100, with higher scores indicating greater disability.
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Week 4, Week 8, and Week 12 after baseline
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Health-related Quality of Life at Weeks 4, 8, and 12 Measured by EQ-5D-5L
時間枠：Week 4, Week 8, and Week 12 after baseline
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Health-related quality of life will be assessed using EQ-5D-5L and compared between groups.
The EQ-5D-5L descriptive system includes 5 dimensions, each scored from 1 to 5. The total descriptive score ranges from 5 to 25, with higher scores indicating more problems and worse health-related quality of life.
The EQ visual analogue scale ranges from 0 to 100, with higher scores indicating better self-rated health status.
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Week 4, Week 8, and Week 12 after baseline
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Change From Baseline in Usual Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale
時間枠：Baseline to Week 4, Week 8, and Week 12
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Change from baseline in usual low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups.
The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain intensity.
A negative change from baseline indicates improvement.
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Baseline to Week 4, Week 8, and Week 12
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Change From Baseline in Worst Low Back Pain Intensity Measured by the 11-point Numeric Pain Rating Scale
時間枠：Baseline to Week 4, Week 8, and Week 12
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Change from baseline in worst low back pain intensity during the past 1 week will be assessed using the 11-point Numeric Pain Rating Scale and compared between groups.
The 11-point Numeric Pain Rating Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain intensity.
A negative change from baseline indicates improvement.
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Baseline to Week 4, Week 8, and Week 12
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Change From Baseline in Functional Disability Measured by the Oswestry Disability Index
時間枠：Baseline to Week 4, Week 8, and Week 12
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Change from baseline in functional disability related to low back pain will be assessed using the Oswestry Disability Index and compared between groups.
The Oswestry Disability Index score ranges from 0 to 100, with higher scores indicating greater disability.
A negative change from baseline indicates improvement.
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Baseline to Week 4, Week 8, and Week 12
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Change From Baseline in Health-related Quality of Life Measured by EQ-5D-5L
時間枠：Baseline to Week 4, Week 8, and Week 12
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Change from baseline in health-related quality of life will be assessed using EQ-5D-5L and compared between groups.
The EQ-5D-5L descriptive system includes 5 dimensions, each scored from 1 to 5. The total descriptive score ranges from 5 to 25, with higher scores indicating more problems and worse health-related quality of life.
The EQ visual analogue scale ranges from 0 to 100, with higher scores indicating better self-rated health status.
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Baseline to Week 4, Week 8, and Week 12
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Treatment Compliance Percentage at Weeks 4 and 8
時間枠：Week 4 and Week 8 after baseline
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Treatment compliance will be assessed as a percentage and compared between the MORA Cure group and the control group.
In the MORA Cure group, compliance will be assessed using data from the clinician web program.
In the control group, compliance will be assessed using the self-exercise diary.
Compliance ranges from 0% to 100%, with higher percentages indicating better treatment compliance.
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Week 4 and Week 8 after baseline
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Psychological Status at Weeks 8 and 12 Measured by the Patient Health Questionnaire-9
時間枠：Week 8 and Week 12 after baseline
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Depression symptoms will be assessed using the Patient Health Questionnaire-9 and compared between groups.
The Patient Health Questionnaire-9 score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
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Week 8 and Week 12 after baseline
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Pain Catastrophizing at Weeks 8 and 12 Measured by the Pain Catastrophizing Scale
時間枠：Week 8 and Week 12 after baseline
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Pain catastrophizing will be assessed using the Pain Catastrophizing Scale and compared between groups.
The Pain Catastrophizing Scale score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
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Week 8 and Week 12 after baseline
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Spinal Muscle Endurance Duration at Weeks 8 and 12 Measured by the Prone Bridge Test
時間枠：Week 8 and Week 12 after baseline
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Spinal muscle endurance will be assessed using the prone bridge test and compared between groups.
The outcome will be measured as the duration that the participant can maintain the prone bridge position, recorded in seconds.
Higher values indicate better spinal muscle endurance.
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Week 8 and Week 12 after baseline
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Radiographic Spinal Alignment Parameters at Week 8 Measured by Whole-spine Lateral X-ray
時間枠：Week 8 after baseline
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Radiographic spinal alignment will be assessed using whole-spine lateral X-ray and compared between groups.
The parameters include lumbar lordosis, pelvic tilt, pelvic incidence, sacral slope, and sagittal vertical axis.
Angular parameters will be measured in degrees, and sagittal vertical axis will be measured in millimeters.
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Week 8 after baseline
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Incidence of Adverse Events
時間枠：From informed consent through Week 12 and applicable safety follow-up period
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Adverse events, adverse device effects, serious adverse events, and serious adverse device effects will be collected and summarized by treatment group.
For adverse device effects, follow-up will be performed as applicable until 14 days after the last use of the investigational medical device.
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From informed consent through Week 12 and applicable safety follow-up period
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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：Cho Jae Hwan, MD, PhD、Asan Medical Center
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)
2026年3月19日
一次修了 (推定)
2026年8月20日
研究の完了 (推定)
2026年9月30日
試験登録日
最初に提出
2026年6月11日
QC基準を満たした最初の提出物
2026年6月17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24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17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
キーワード
その他の研究ID番号
- EX-CU-LB-02
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
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
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。