Arthralgia
Conditions
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 description
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.
Interventions
Use of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.
DRUGPlacebo
Use of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* age between 45 and 55 years * chronic arthralgia related to climacteric * regular mammography and pap smear test in the last twelve months * availability to attend hormone replacement therapy * maximum of ten years of amenorrhea according to the criteria of Stages of Reproductive Aging Workshop (STRAW) * without use of hormone replacement therapy, at least, previous six months * no contraindication to hormone replacement therapy (current or past of breast and / or cervical cancer, severe current or recent heart disease, thromboembolism, hypertension with no control, metabolic diseases (but stable thyroid disease) and endometrial hyperplasia to be enlightened * Informed consent
Exclusion criteria
* autoimmune diseases * visceral pain (chronic pelvic pain, dyspareunia, irritable bowel syndrome) * systemic diseases (rheumatic, neurological, oncology, sexually transmitted infection) * body mass index of 30 or greater * soy diet * abuse of alcohol and drugs * large surgeries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arthralgia | 6 months | Arthralgia´ll be measured by numeric scale (0-10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of physical activity | 6 months | Level of physical activity´ll be evaluated by International Physical Activity Questionnaire - Brazilian Version whose three levels of physical activity are low, moderate and high. |
| Pain Catastrophizing | 6 months | Pain Catastrophizing´ll be evaluated by Pain Catastrophizing - Brazilian Version into three subscales being magnification, rumination, and helplessness. The higher the score, the more catastrophizing thoughts are present. |
| Health-related quality of life | 6 months | Quality of life´ll be evaluated by Women´s Health Questionnaire - Brazilian Version (somatic symptoms, depressed mood, cognitive difficulties, anxiety and fear, sexual functioning, vasomotor symptoms, sleep problems, menstrual problems, and self-perceived attraction). The higher the score, the more pronounced the suffering and dysfunction. |
| Climacteric symptoms | 6 months | Climacteric symptoms´ll be evaluated by Menopause Rating Scale - Brazilian Version. The score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items. |
| Anxiety | 6 months | Anxiety´ll be evaluated by Beck Anxiety Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression. |
| Quality of sleep | 6 months | Quality of sleep´ll be evaluated by Pittsburgh Sleep Quality Index - Brazilian Version. Lower scores denote a healthier sleep quality. |
| Depression | 6 months | Depression´ll be evaluated by Beck Depression Inventory - Brazilian Version. The standard cut-off scores are minimal, mild, moderate and severe depression. |
Countries
Brazil
Contacts
Primary ContactMaria Celeste Osório Wender, Ph.D
Backup ContactFernanda Vargas Ferreira, Ph.D
Outcome results
None listed