Moxibustion for Knee Osteoarthritis

NCT01354860 | Completed Phase 1 DMC

• 1 other identifier: KI1002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the feasibility, effectiveness and safety of moxibustion for symptom management and function improvement in patients with knee osteoarthritis, compared to usual care group.

Conditions

Idiopathic Osteoarthritis

Keywords

knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale

  The primary outcome is the knee pain measured by WOMAC pain subscale at 4 weeks from baseline.

  4 weeks from baseline

Secondary Outcomes (7)

• The change from baseline to 4, 8 and 12 weeks in the Short Form Health Survey (SF)-36

  at base line, 4 ,8 and 12 weeks later after allocation

• The change from baseline to 4, 8 and 12 weeks in the Beck Depression Inventory(BDI)

  at base line, 4 ,8 and 12 weeks later after allocation

• The change from baseline to 4, 8 and 12 weeks in the Patient global assessment

  4 ,8 and 12 weeks later after allocation

• The change from baseline to 4, 8 and 12 weeks in the physical performance test

  at a baseline, 4 ,8 and 12 weeks later after allocation

• The change from baseline to 4, 8 and 12 weeks in the Numeric Rating Scale (NRS) for pain

  at a baseline, 4 ,8 and 12 weeks later after allocation

Study Arms (2)

Moxibustion treatment plus usual care

EXPERIMENTAL

Other: Moxibustion treatment plus usual care

usual care alone

NO INTERVENTION

Other: Usual care alone group

Interventions

Moxibustion treatment plus usual care OTHER

Treatment group received moxibustion treatment three times a week for 4 consecutive weeks, totally 12 sessions of treatment in addition to usual care to manage their knee OA. Moxibustion points include six local acupuncture points on affected knee joint. Up to two additional tender points will be allowed, if necessary. If participants feel knee pain on both knee joints, study practitioners will provide treatment on both knee. We will use smokeless indirect moxibustion made of wormwood with a diameter of 1.9 centirmeter and a length of 2.1 centimeter in a cylindrical form for this study (Haitnim Bosung Inc, Korea). Free participant-practitioner interaction will be allowed during the treatment session. Expected total time of each treatment session will be 40 - 60 minutes.

Also known as: Smokeless indirect moxibustion produced by Haitnim Bosung Inc, Korea.

Moxibustion treatment plus usual care

Usual care alone group OTHER

Usual care alone group can receive or use any kind of treatment other than moxibustion treatment provided as study intervention, which includes surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatment. This also applies to the moxibustion treatment group. Education material of information on knee osteoarthritis and current management option and self-exercise sheet with a yoga-mat to enhance regular exercise will be provided in both groups at baseline.

usual care alone

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 40 to 70 years old
• Average daily knee pain over 40 points (0-100 point scale)
• diagnosed as knee osteoarthritis according to ACR criteria

You may not qualify if:

• Current of past history of inflammatory disease including rheumatoid arthritis
• Cancer
• Traumatic injury which might be related to current knee pain
• Autoimmune disease
• significant deformity of knee joints
• knee replacement surgery on affected knee
• knee arthroscopy within 2 years
• steroid injection in knee joints within 3 months
• viscosupplement injections in knee joints within 6 months
• joint fluid injection within 6 months
• received acupuncture, moxibustion, cupping or herbal medicine within 4 weeks
• uncontrolled hypertension
• diabetes mellitus requiring insulin injection
• life-threatening cardiovascular or neurological events within one year
• chronic respiratory disease

Sponsors & Collaborators

• Korea Institute of Oriental Medicine: lead

Study Sites (1)

Daejeon University Hospital

Daejeon, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sun Mi Choi, PhD

  Korea Institute of Oriental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 17, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 17, 2011

Record last verified: 2010-09

Locations

KR (1)