Dataset Information

Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Knee osteoarthritis (KOA) is commonly seen and has a high occurrence in the middle-aged and elderly. It is characterized by the degeneration and secondary bone hyperplasia of the articular cartilage; the pathologic changes are irreversible. Therefore, treatment of KOA is mainly focused on relieving pain, reducing inflammation, improving or restoring joint function, delaying disease progression, and increasing quality of life. Crossbow needle therapy of the Miao ethnic minority group is intended for KOA treatment and has been widely used. Studies of small sample size have seen significant improvement on pain relief, stiffness, and joint function.

Methods/design

The trial is a randomized, multicenter, parallel, non-inferiority study. Three hundred and six patients will be randomly assigned to a crossbow needle group (n?=?153) and an acupuncture group (n?=?153). Patients in each group will receive treatment every other day, three times a week, 20 times in total. Follow-up will be conducted 15 days and 30 days after treatment. The primary outcome will be the Western Ontario and McMaster Osteoarthritis Index (WOMAC) score at baseline, the end of treatment, first follow-up, and second follow-up. The secondary outcomes will include Lysholm knee score, Japanese Orthopedic Association (JOA) knee score, visual analogue scale (VAS), and the MOS 36-item short-form health survey (SF-36).

Discussion

The results of the trial will compare the efficacy on KOA between crossbow needle group and acupuncture group and will be expected to make a systematic and objective evaluation of crossbow needle therapy.

Trial registration

ChiCTR, ChiCTR-INR-16008032 . Registered on 12 March 2016.

SUBMITTER: Fu J

PROVIDER: S-EPMC6020384 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Publications

Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial.

Fu Jing J Shang Hong-Cai HC Wang Li-Ying LY Zhao Chen C Cui Jin J Wang Yan-Ping YP

Trials 20180627 1

<h4>Background</h4>Knee osteoarthritis (KOA) is commonly seen and has a high occurrence in the middle-aged and elderly. It is characterized by the degeneration and secondary bone hyperplasia of the articular cartilage; the pathologic changes are irreversible. Therefore, treatment of KOA is mainly focused on relieving pain, reducing inflammation, improving or restoring joint function, delaying disease progression, and increasing quality of life. Crossbow needle therapy of the Miao ethnic minority ...[more]

PMID: 29945672

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Project description:BACKGROUND:Osteoarthritis (OA) is the most prevalent chronic joint disease, characterized by joint structural deterioration, pain and loss of function among the elders. It is also associated with several extra-articular symptoms (fatigue, sleep disorders, anxiety and depression) and a reduction of life quality. Studies have revealed that patients with OA benefitted from enhanced management via telemedicine. Guangdong Online Hospital (GOH) is the first officially recognized web-based hospital that provides telemedicine service in China. However, the effective implementation of GOH telemedicine (GOHT) to enhance management for patients with OA remains unknown. METHODS/DESIGN:An assessor-blinded, parallel randomized controlled trial will be performed to study the feasibility and effectiveness of GOHT in the enhanced management of OA. Forty participants with knee OA will be recruited for a 6-month study. Patients meeting the inclusion criteria will be randomly allocated to receive conventional therapy (CT) or conventional therapy plus a brief GOH-based intervention (CT-GOHT). The primary outcome is the feasibility of a full-scale randomized controlled trial. The secondary outcomes include the self-reported total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Multidimensional Fatigue Inventory (MFI), the Pittsburgh Sleep Quality Index (PSQI) and the Hospital Anxiety and Depression Scale (HADS). Assessments will be performed at baseline, 2 weeks, 3 months and 6 months later after the initiation of the study. DISCUSSION:This trial is intended to test the application of GOHT in the chronic management in knee OA. The hypothesis is that OA patients may receive disease management via this network platform conveniently and effectively, especially those in the remote areas of our country. GOHT telemedicine would be an attractive alternative to traditional methods for disease management in knee OA. The results could provide preliminary experiences and guidance for an upcoming full-scale randomized controlled trial (RCT) in disease management via telemedicine. TRIAL REGISTRATION:ChiCTR: ChiCTR1800014465 . Registered on 16 January 2018.

Dataset Information

Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial.

Similar Datasets

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