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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, physical function and quality of life when compared with placebo in women with chronic back pain treated with opioids who have low testosterone.
This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 3 months of treatment with testosterone or placebo in women aged 60 years or older with chronic non-cancer back pain who are taking opioid analgesics for at least 6 months and have low testosterone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone | Experimental | Weekly intramuscular administration at a dose of 3 mg |
|
| Placebo | Placebo Comparator | Weekly intramuscular administration of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Cypionate | Drug | Weekly intramuscular administration of testosterone at a dose of 3 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference Subscale score of the Brief Pain Inventory (BPI) questionnaire | The Pain Interference Subscale of the BPI is specifically relevant to patients with chronic back pain who are using opioids and correlates strongly with the patient's quality of life. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Algometer-induced Pressure Pain | A digital pressure algometer at the trapezius muscle and the metacarpophalangeal joint of the thumb was used to measure pressure pain thresholds. Higher values represent a better tolerance of pressure pain. | 3 months |
| Weighted Pinprick Stimulator-induced Mechanical Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shehzad Basaria, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C016131 | testosterone 17 beta-cypionate |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | Weekly intramuscular administration of Placebo |
|
Weighted pinprick stimulators are used to assess mechanical pain. Lower values represent better tolerance of pain |
| 3 months |
| Ice Water-induced Cold Pain and Its After-sensation | Cold-pressor tests measure cold-induced pain and its sensation. Time was measured when a participant reached pain tolerance in cold water and after sensation. Higher values of time in Cold pain tolerance and lower values of time in Cold pain after-sensation (30 seconds) represent better tolerance of pain. | 3 months |
| Health Quality of Life (QoL) as Assessed by Short Form 36 (SF-36) | The SF-36 measures 8 domains of the QoL: physical function, bodily pain, vitality, role limitations due to physical problems, general health perceptions, emotional well-being, social function, and role limitations due to emotional problems. Each domain is scored separately from 0 to 100 with higher scores representing better health-related QoL. | 3 months |
| Mood and well-being, assessed using the by Positive and Negative Affect Scale (PANAS) affectivity balance scale | The PANAS affectivity balance scale includes 10 questions evaluating positive and negative affect. | 3 months |
| Physical function, assessed using the 6-minute walk test (6-MWT) | Subjects will be asked to walk for 6 minutes at a comfortable pace on a premeasured flat surface; gait speed will be calculated by the distance walked (m) in 6 minutes. The 6-minute walk test (6-MWT) is an objective test of physical function validated in older adults and in women with chronic low back pain. | 3 months |
| Sexual Function assessed by the Female Sexual Distress Scale (FSDS) | For this 13-item questionnaire, women rate each item in terms of frequency from 0 (never) to 4 (always). Items are summed to create a total score ranging from 0 to 52, with higher scores indicating more sexually related distress | 3 months |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |