Clinical Trial: Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effects of Hormone Replacement Therapy on Arthralgia in Postmenopausal Women: a Randomized, Double-blind Controlled Trial

Brief Summary: Arthralgia has been a common complaint in postmenopausal period which seems to be involved with estrogen depletion, although, its pathophysiology isn´t completely clarified. It seems to relate with the level of physical activity, climacteric symptoms and pain catastrophizing. In view of the multiple dimensions involved in arthralgia in postmenopausal women which characterize it as a complex phenomenon, this study aims to describe the effects of hormone replacement therapy in women aged between 45 and 55 years, considering estrogen as a possible anti-nociceptive factor.

Detailed Summary: This study is a randomized double-blind controlled clinical trial with postmenopausal women aged between 45 and 55 years with chronic arthralgia related to climacteric. They will be evaluated climacteric symptoms, pain intensity, level of physical activity, pain catastrophising, depression, anxiety, quality of sleep and quality of life. The volunteers will be randomized, in the proportion 1:1, to treatment with either 0,625 mg conjugated equine estrogen, via oral administration, for 12 weeks or placebo, via oral administration, for 12 weeks. The randomization will be performed by a computer-generated random numbers list. The investigators will be blinded until completion of 12 weeks. Evaluation of climacteric symptoms, pain intensity, level of physical activity, pain catastrophising, depression, anxiety, quality of sleep and quality of life will be performed in the hospital at baseline, 1, 2, 3, 6 months and 15 days. In each visit, participants will be evaluated about adverse effects such as diarrhea, nausea and vomit.
Sponsor: Hospital de Clinicas de Porto Alegre

Current Primary Outcome: Arthralgia [ Time Frame: 6 months ]

Arthralgia´ll be measured by pain intensity number scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Climacteric symptoms [ Time Frame: 6 months ]
    Climacteric symptoms´ll be evaluated by Menopause Rating Scale - Brazilian Version
  • Level of physical activity [ Time Frame: 6 months ]
    Level of physical activity´ll be evaluated by International Physical Activity Questionnaire - Brazilian Version
  • Pain Catastrophizing [ Time Frame: 6 months ]
    Pain Catastrophizing´ll be evaluated by Pain Catastrophizing - Brazilian Version
  • Quality of life [ Time Frame: 6 months ]
    Quality of life´ll be evaluated by Women´s Health Questionnaire - Brazilian Version
  • Depression [ Time Frame: 6 months ]
    Depression´ll be evaluated by Beck Depression Inventory - Brazilian Version
  • Anxiety [ Time Frame: 6 months ]
    Anxiety´ll be evaluated by Beck Anxiety Inventory - Brazilian Version
  • Quality of sleep [ Time Frame: 6 months ]
    Quality of sleep´ll be evaluated by Pittsburgh Sleep Quality Index - Brazilian Version


Original Secondary Outcome: Same as current

Information By: Hospital de Clinicas de Porto Alegre

Dates:
Date Received: June 9, 2016
Date Started: November 2016
Date Completion: June 2018
Last Updated: July 15, 2016
Last Verified: July 2016