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The goal of this clinical trial is to investigate the effect of adding transcutaneous electrical nerve stimulation to cognitive behavior therapy on fibromyalgia in postmenopausal women.
The study aims to answer whether there would be an effect of adding TENS to cognitive behavior therapy (CBT) and medicines on pain, symptoms, HRV, and QOL in postmenopausal women with fibromyalgia
The primary hypothesis is that there would be no effect of adding TENS to CBT and medicines on pain, symptoms, Heart rate variability (HRV), and quality of life (QOL) in postmenopausal women with fibromyalgia.
Sixty postmenopausal women with mild to moderate fibromyalgia were allocated to 3 groups: Group A received medical treatment, Group B received medical treatment and CBT, and Group C received the same as B and low TENS.
Pain was assessed using the widespread pain index (WPI) and pain pressure threshold (PPT). Fibromyalgia symptoms were evaluated using the symptoms severity index (SSI). Heart rate variability (HRV) and quality of life were assessed using the Fibromyalgia Impact Questionnaire (FIQ).
It is a three-armed, single-blind, parallel group randomized controlled trial. All patients who met the study's inclusion criteria were randomly allocated using a computerized randomization procedure to one of three groups with a 1:1:1 ratio. A blind researcher to the patient assignment evaluated the patient before and after the treatment procedures.
Sixty postmenopausal women with mild to moderate fibromyalgia were recruited from the rheumatology clinic at Al Kasr Al Ainy Hospital and the faculty of physical therapy outpatient clinic.
Patients were randomly allocated to three different groups: Group A received medical treatment in the form of pain relievers such as acetaminophen and antidepressants such as Duloxetine (Cymbalta) and milnacipran. Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks. Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks. There were no patient withdrawals throughout the study.
Pain was assessed using the widespread pain index (WPI) and pain pressure threshold (PPT). Fibromyalgia symptoms were evaluated using the symptoms severity index (SSI). Heart rate variability (HRV) and quality of life were assessed using the Fibromyalgia Impact Questionnaire (FIQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (A) | Active Comparator | Group (A) received medical treatment in the form of pain relievers such as acetaminophen and antidepressants such as Duloxetine (Cymbalta) and milnacipran. |
|
| Group (B) | Active Comparator | Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks. |
|
| Group (C) | Experimental | Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | Name: Transcutaneous Electrical Nerve Stimulation (TENS). Type: device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the pain distribution | The Widespread Pain Index (WPI) is a self-report index measure that was used to assess bodily distribution of pain and to specifically quantify the degree of widespread body pain and assess for pain features (e.g., cognitive, emotional, and physical symptoms). The WPI assesses the presence of pain in 19 designated body locations over the past 7 days, such as the neck, right upper arm, left lower leg. Each location is equal to a score of 1. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Severity Scale (SSI) | A total SSS score ranged from 0 to 12, with each score ranging from zero to three. Zero indicated no problem, one indicated slight or mild problems, two indicated moderate problems, and three indicated severe problems . | Baseline and after 12 weeks |
| Assessment of pain threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enas Abd Elazim, Dr. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical therapy outpatient clinics and Rheumatology clinic at Al Kasr Al Ainy Hospital | Cairo | Non US Or Canada | Egypt |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D015928 | Cognitive Behavioral Therapy |
| D000082 | Acetaminophen |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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It is a three-armed, single-blind, parallel group randomized controlled trial. All patients who met the study's inclusion criteria were randomly allocated using a computerized randomization procedure to one of three groups with a 1:1:1 ratio.
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| Cognitive behavior therapy | Behavioral | Type: Behavioral Name: Cognitive Behavioral Therapy (CBT) |
|
|
| medical treatment | Drug | Type: Drug Name: Medical treatment (acetaminophen, duloxetine) |
|
|
A pressure algometer was used to deliver pressure pain on a skin area of 1 cm2 between the thumb and index finger |
| Baseline and after 12 weeks |
| Assessment of heart rate variability (HRV) | Electrocardiogram signal (ECG) (Philips Medical Systems, 3000 Minuteman Rd, Andover MA01810, USA). All signals were blindly analyzed. The acquisition of electrocardiogram signal (ECG) was performed immediately before and after the interventions for 10 minutes | Baseline and after 12 weeks |
| Assessment of fibromyalgia symptoms | The questionnaire consists of 20 item that measure physical function like (feel good (1 item), missed work (1 item), do job (1 item), pain (1 item), fatigue (1 item), rested (1 item), stiffness (1 item), and cognitive function like (anxiety (1 item), and depression (1 item). Each patient in all groups was carefully instructed about the questionnaire. | Baseline and after 12 weeks |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |