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

1 janvier 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

90

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Changhe Yu
  • Numéro de téléphone: 0086-18601159559
  • E-mail: yakno2@163.com

Sauvegarde des contacts de l'étude

  • Nom: Xiyou Wang
  • Numéro de téléphone: 0086-8610111889
  • E-mail: dwxy658@163.com

Lieux d'étude

  • Chine
    • Beijing
      • Beijing, Beijing, Chine
        • Recrutement
        • Beiing university of Chinese medicine Dongzhimen Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Comparateur actif: 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.
Médicament: Flurbiprofen Cataplasms group (FCG).
One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days
Autres noms:
  • ZePuSi

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in NRS scores for pain intensity
Délai: Change from baseline at 14 days
The changes in NRS scores at 14 days after randomization.
Change from baseline at 14 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in NRS scores for pain intensity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beijing University of Chinese Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 octobre 2021

Achèvement primaire (Anticipé)

15 février 2022

Achèvement de l'étude (Anticipé)

15 mai 2022

Dates d'inscription aux études

Première soumission

15 juillet 2021

Première soumission répondant aux critères de contrôle qualité

15 juillet 2021

Première publication (Réel)

26 juillet 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 janvier 2022

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2021DZMEC-070-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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