Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients

NCT03956875 | Completed

• 1 other identifier: CMUH107-REC3-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study was to investigate the therapeutic effect of Yoga on aromatic inhibitor-induced chronic knee pain in patients with breast cancer.

Conditions

Breast Cancer; Aromatase Inhibitor; Yoga; Knee Pain

Outcome Measures

Primary Outcomes (1)

• womac questionnaire

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.

  3 minutes

Secondary Outcomes (1)

• M.E.A.D (Meridian Energy Analysis Device)

  5minutes

Study Arms (2)

yoga

ACTIVE COMPARATOR

Yoga treatment

Other: yoga

massage

PLACEBO COMPARATOR

massage

Other: yoga

Interventions

yoga OTHER

yoga is a mind-body practice that guides the body through a series of poses and breathing exercises

Also known as: massage

massage; yoga

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with breast cancer and is taking an aromatic ring enzyme inhibitor. Knee joint pain for more than three months. Ages are over 20 years old and under 70 years old.

You may not qualify if:

• At the same time, there are multiple sources of pain associated with non-breast cancer, such as visceral pain, traumatic pain, which must be excluded by the moderator.
• Addicted drug abusers, subject to the judgment of the host. Women who may be pregnant, pregnant women, within three months after childbirth.
• Have a serious mental illness or an unstable mental state, which will affect the clinical assessment.
• Severe hearing impairment, visual impairment, or dementia. It is not easy to measure by the host.
• Limb edema and severe skin damage are not suitable for yoga practitioners by the physician.
• The spinal lesions are excessively severe, affecting the normal function of the operation, and the test cannot be completed.
• Have been a yoga practitioner for nearly a month, or a regular exerciser for over 90 minutes per week for the past month.
• Cancer has been transferred (stage IV)

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Ching-Liang Hsieh

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Yoga; Massage

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Therapy, Soft Tissue; Musculoskeletal Manipulations; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators designed a crossover study, a total of 60 patients divided equally to control group (massage for 6 weeks in home care) and treatment group (Yoga treatment for 12 times/6 weeks).

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: March 10, 2019
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

TW (1)