Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis

Knee Arthritis Osteoarthritis Clinical Trial

Official title:

Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446756
• Other study ID #: PUMCH20150430
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: May 13, 2015
• Start date: January 2010
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two random groups. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.

Description:

To observe the therapeutic effect of acupuncture on osteoarthritis and its efficacy on cartilage restoration,one hundred knees of 50 patients with knee osteoarthritis were randomly divided into acupuncture group and physiotherapy group which were respectively received acupuncture and physiotherapy treatment for four weeks. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinically diagnosed as knee osteoarthritis according to the OA criteria proposed by American College of Rheumatology in 1995.

Exclusion Criteria:

• Acute knee injury

• Had ever accepted therapy as hormone or injection in articulation cavity

• Had ever accepted treatment as oral medicine, physiotherapy, acupuncture or massage during the passed three months

• Had planted cardiac pacemaker or any metal matter in body

• Other severe diseases such as heart, lung, liver, kidney or cerebrum failure, tumors, gastrointestinal hemorrhage and so on

• Pregnant or lactating woman

• Anyone unable to tolerate or cooperate with treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthritis Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• acupuncture

• physiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC scores		up to 24 months	Yes
Primary	T2 Values		up to 30 months	Yes