Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Chinese Tuina Therapy for Treatment of Chronic Nonspecific Low Back Pain (CNLBPCT)

1. Januar 2022 aktualisiert von: Changhe Yu, Beijing University of Chinese Medicine

Effectiveness, Safety and Economic Evaluation of Chinese Tuina (Chinese Massage and Flurbiprofen Cataplasms) in the Treatment of Chronic Nonspecific Low Back Pain

Chronic Nonspecific Low back Pain (NLBP) is a common symptom in today's society. It causes serious health and economic burdens. Low back pain can be attributed to excessive physical exertion or trauma, resulting in damage or degradation of the vertebrae, intervertebral discs, or spinal muscles and nonspecific low back pain typically can account for 90% of the patients with 35 to 55 years old. Some guidelines endorse the cautious use of medication and surgery and take nonpharmacological and noninvasive treatments as a first-line treatment, including routine health education, exercise, psychotherapy, and physical therapies, owing to the risk of trauma and the cost. With a long history, Tuina is a one of the common nonsurgical methods to treat LBP in China.. The effect of Tuina is attributed to relaxing muscles and tendons, improving circulation, regulating spinal balance, decreasing edema and aseptic inflammation. Many clinical reports have confirmed its effectiveness, but more clinical trials are required to provide evidence of Tuina for low back pain. Therefore, this study was designed to compare the effectiveness of Tuina with Flurbiprofen Cataplasms for patients with low back pain on the basis treatment of health education and self-management exercise at home.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is a single-center, assessor- and analyst-blinded randomized controlled trial conducted in Beijing, China, at Dongzhimen hospital affiliated to Beijing university of Chinese medicine. In total, 90 patients will be recruited and randomly assigned to a Tuina group and a Flurbiprofen Cataplasms group in a 1:1 ratio. The Chinese Tuina group will be given twice per week for 14 days, and medicine group will be given Flurbiprofen Cataplasms twice daily for 14 days. We will ask some researchers who are blinded to assignment to accomplish the outcome assignment and statistical analyses independently. The outcome will be measured by three self-report questionnaires, which can reflect the lumbar dysfunction, pain, quality of life, and adverse events. Four time points will be used to assess outcomes, including baseline, 7 days, 14 days and 28 days after randomization.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

90

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Changhe Yu
  • Telefonnummer: 0086-18601159559
  • E-Mail: yakno2@163.com

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Beijing
      • Beijing, Beijing, China
        • Rekrutierung
        • Beiing university of Chinese medicine Dongzhimen Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Diagnosis of non-specific low back pain;
  • Aged between 18 and 65,male and female;
  • Duration of low back pain as the main symptom for at least 12 weeks;
  • pain intensity with NRS score equals or more than 4;
  • X-ray or CT on low back helped to confirm no lumbar diseases;
  • Ability to understand and complete the questionnaires;
  • Any treatments aiming to CNLBP need more than 1 month washout period;
  • Volunteer to participate in the study and informed consent form.

Exclusion Criteria:

  • Sciatica, myelopathy, displacement, or radiculopathy due to lumbar intervertebral disc disorders or Spondylolisthesis；
  • Chronic low back pain caused by local disease (e.g., lumbar fracture, lumbar tumor, lumbar tuberculosis, lumbar spine surgery or trauma)；
  • Immune diseases such as rheumatoid joints and ankylosing spondylitis；
  • Severe primary disease such as cardiovascular, lung, kidney, and hematopoietic disease;
  • Pregnant or lactating women;
  • patients with skin injury;
  • Allergy or intolerance to Non-steroidal anti-inflammatory drug (e.g., asthma, gastrointestinal ulcers, and bleeding);
  • Mental illness；
  • Poor compliance of examination and treatment.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Chinese Tuina group (CTG)
The participants in Chinese Tuina group will receive the traditional Chinese Tuina therapy on the basis of health education and home-exercise. All the treatment will cost 20-25 minutes. Patients in this group received 4 treatments over 14 days.
Verhalten: Chinese Tuina therapy
Firstly, the patient is in the prone position, and the doctor use the method of rolling or kneading the Bladder meridians on both sides of the spine. The waist will be focused on to manipulate preferentially and then using the same technique on the patient's back, buttocks and lower limbs. Secondly, the physician will perform the manipulation on the patient's waist and the posterolateral side of the lower limbs by pressing, kneading, plucking. The doctors press the acupoints, including Mingmen(DU04),Shenshu(BL23),Yaoyangguan(DU03),Huantiao(GB30), Weizhong(BL40),Chengshan(BL57),and Ashi points, with the elbow or the thumb to achieve Deqi sensation. Thirdly, the The doctor uses the method of pressing acupoints, including Tianshu(ST25),Qichong(ST30),Chongmen(SP12),Daimai(GB26),Jingmen(GB25) on both sides. Fourthly, the patient is required to face the doctor in a lateral position for pulling manipulation on the both sides of lumbar vertebrae.
Aktiver Komparator: Flurbiprofen Cataplasms group (FCG)
The FCG group received flurbiprofen gel on the basis of the health education and home-exercise, twice daily, for 14 days.
Arzneimittel: Flurbiprofen Cataplasms group (FCG).
One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days
Andere Namen:
  • ZePuSi

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in NRS scores for pain intensity
Zeitfenster: Change from baseline at 14 days
The changes in NRS scores at 14 days after randomization.
Change from baseline at 14 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in NRS scores for pain intensity
Zeitfenster: Change from baseline at 7 days and 28 days after randomization
The NRS scores are measured at baseline, 7 days and 28days after randomization
Change from baseline at 7 days and 28 days after randomization
Changes in the ODI scores for lumbar function
Zeitfenster: Change from baseline at 7 days,14 days and 28 days after randomization
The ODI (Oswestry Low Back Pain Disability Index) scores are measured at baseline, 7 days, 14 days and 28 days after randomization
Change from baseline at 7 days,14 days and 28 days after randomization
Clinical effective rate
Zeitfenster: Change from baseline at 7days,14days and 28 days after randomization
The clinical response rate is measured at baseline, 7 days, 14 days and 28 days after randomization
Change from baseline at 7days,14days and 28 days after randomization
Changes in 7-level Likert Scale for patient assessment global improvement
Zeitfenster: Change from baseline at 7 days,14 days and 28 days after randomization
The PAG with 7-level Likert Scale is measured at baseline, 7 days, 14 days and 28 days after randomization
Change from baseline at 7 days,14 days and 28 days after randomization
Changes in PROMIS® Scale v1.2 Scale for patient assessment global improvement
Zeitfenster: Change from baseline at 14 days after randomization
The PAG with PROMIS® Scale v1.2 Scale is measured at baseline, 14 days after randomization
Change from baseline at 14 days after randomization
Changes in the Quebec Low Back Pain Disability Scale scores for lumbar function
Zeitfenster: Change from baseline at 14 days after randomization
The Quebec Low Back Pain Disability Scale scores are measured at baseline and 14 days after randomization
Change from baseline at 14 days after randomization
Changes in PROMIS® Item Bank v2.0-Physical Function scores for Physical Function
Zeitfenster: Change from baseline at 14 days after randomization
The PROMIS® Item Bank v2.0-Physical Function-Short Form 8c 7-Day Scale scores are measured at baseline and 14 days after randomization
Change from baseline at 14 days after randomization
Changes in Quality adjusted life years (QALY)
Zeitfenster: Change from baseline at 7 days,14 days and 28 days after randomization
The quality adjusted life years (QALY) of the subjects were measured by TCM health-related life quality scale (CM-QOL), five-dimensional health scale (EQ-5D) and SF-6D at baseline, 7 days, 14 days and 28 days after randomization
Change from baseline at 7 days,14 days and 28 days after randomization
Incidence of adverse events
Zeitfenster: Change from baseline at 7 days,14 days and 28 days after randomization
The incidence of adverse events during treatment will be calculated
Change from baseline at 7 days,14 days and 28 days after randomization
Cost-Effectiveness Analysis (CEA) ratio
Zeitfenster: Change from baseline at 7 days,14 days and 28 days after randomization
The cost-effectiveness ratio (C/E) is measured at baseline,7days,14 days and 28 days after randomization
Change from baseline at 7 days,14 days and 28 days after randomization
Cost-utility analysis (CUA) ratio
Zeitfenster: Change from baseline at 7 days,14 days and 28 days after randomization
The cost-utility ratio (C/U) is measured at baseline,7days,14 days and 28 days after randomization
Change from baseline at 7 days,14 days and 28 days after randomization
Incremental cost-effectiveness ratio and Incremental cost-utility ratio
Zeitfenster: Change from baseline at 7 days,14 days and 28 days after randomization
Incremental cost-effectiveness ratio and Incremental cost-utility ratio are measured at baseline,7days,14 days and 28 days after randomization.
Change from baseline at 7 days,14 days and 28 days after randomization

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Beijing University of Chinese Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Oktober 2021

Primärer Abschluss (Voraussichtlich)

15. Februar 2022

Studienabschluss (Voraussichtlich)

15. Mai 2022

Studienanmeldedaten

Zuerst eingereicht

15. Juli 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juli 2021

Zuerst gepostet (Tatsächlich)

26. Juli 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Januar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Januar 2022

Zuletzt verifiziert

1. Januar 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2021DZMEC-070-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Chinese Tuina therapy

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Congo, DR of

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren