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

1 januari 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Changhe Yu
  • Telefoonnummer: 0086-18601159559
  • E-mail: yakno2@163.com

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Geneesmiddel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in NRS scores for pain intensity
Tijdsspanne: Change from baseline at 14 days
The changes in NRS scores at 14 days after randomization.
Change from baseline at 14 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in NRS scores for pain intensity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beijing University of Chinese Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 oktober 2021

Primaire voltooiing (Verwacht)

15 februari 2022

Studie voltooiing (Verwacht)

15 mei 2022

Studieregistratiedata

Eerst ingediend

15 juli 2021

Eerst ingediend dat voldeed aan de QC-criteria

15 juli 2021

Eerst geplaatst (Werkelijk)

26 juli 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 januari 2022

Laatste update ingediend die voldeed aan QC-criteria

1 januari 2022

Laatst geverifieerd

1 januari 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2021DZMEC-070-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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