NCT02446756

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

January 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

3.5 years

First QC Date

May 6, 2015

Last Update Submit

May 13, 2015

Conditions

Knee Arthritis Osteoarthritis

Keywords

OsteoarthritisMRICartilageAcupuncture

Outcome Measures

Primary Outcomes (2)

  • WOMAC scores

    up to 24 months

  • T2 Values

    up to 30 months

Study Arms (2)

acupuncture group

EXPERIMENTAL

Acupuncture treatment was given once every other day and 20min each time for four weeks.

Other: acupuncture

physiotherapy group

ACTIVE COMPARATOR

Physiotherapy treatment was given five times a week and 30min each time for four weeks.

Other: physiotherapy

Interventions

acupunctureOTHER
acupuncture group
physiotherapyOTHER
physiotherapy group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Acupuncture TherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 18, 2015

Study Start

January 1, 2010

Primary Completion

July 1, 2013

Study Completion

February 1, 2014

Last Updated

May 18, 2015

Record last verified: 2015-05