NCT04492670

Brief Summary

The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on the treatment of KOA. This is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have 4-week of treatment, and then a 4-week follow-up.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2.2 years

First QC Date

July 28, 2020

Last Update Submit

June 21, 2022

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis, Tui-na, Chinese medicine

Outcome Measures

Primary Outcomes (1)

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96

    4 weeks

Secondary Outcomes (2)

  • EQ-5D-EL questionnaire

    8 weeks

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    at 2 weeks and 8 weeks

Study Arms (2)

Tui-na and oral Chinese medicine

EXPERIMENTAL

8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks

Procedure: Tui-naDrug: Du-Huo-Ji-Sheng-Tang (DHJST)

Tui-na

OTHER

8 sessions of 20 minutes Tui-na for 4 weeks

Procedure: Tui-na

Interventions

Tui-naPROCEDURE

For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience. The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.

Tui-naTui-na and oral Chinese medicine
Du-Huo-Ji-Sheng-Tang (DHJST)DRUG

This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.

Also known as: Herbal granules
Tui-na and oral Chinese medicine

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • of either gender (female must have either sterilization done or menopause)
  • ≥50years of age
  • meet the criteria of KOA according to the American College of Rheumatology
  • Knee pain, and
  • Any 4 of the following,
  • ≥ 50 years of age
  • Less than 30 minutes of morning stiffness
  • Crepitus on active motion
  • Bony tenderness
  • Bony enlargement
  • No palpable warmth of synovium
  • Osteophytes (Radiographic findings)
  • with WOMAC score ≥ 39
  • with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission)

You may not qualify if:

  • Known knee pain caused by infection, malignant or autoimmune diseases
  • Knee surgery or arthroscopy in the past year
  • Chondroprotective or intra-articular injection in the past 4 months
  • Systemic corticoid treatment in the past 4 months
  • Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs
  • Subject with uncontrolled hypertension
  • Local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks
  • Known history of mental disorder
  • Known history of serious acute organic disease
  • Renal or liver function impairment
  • Known allergy to or have drug interaction with the study herb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Chan KH, Ching JYL, Chan KL, Lau HY, Chu KM, Chan K, Pang HF, Wong LC, Chia CP, Zhang HW, Song T, Leung SB, Ng BFL, Lin ZX. Therapeutic effect of Duhuo Jisheng Decoction add-on Tui-na manipulation on osteoarthritis of knee: a randomized controlled trial. Chin Med. 2023 Jul 10;18(1):82. doi: 10.1186/s13020-023-00737-5.

    PMID: 37424023DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Zhixiu Lin, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 30, 2020

Study Start

September 14, 2020

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)