FibromyalgiaNCT07533487
Adding Neuromodulation Technique to Cognitive Behavior Therapy on Fibromyalgia in Postmenopausal Women
A study testing TENS, Cognitive behavior therapy and medical treatment in people with Fibromyalgia, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- TENS, Cognitive behavior therapy and medical treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients aged 50-60 years old
- body mass index (BMI) between 25 and 29.9 kg/m2
- patients meeting the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia syndrome, including a widespread pain index (WPI) score of 7 or more, a symptom severity (SS) score of 5 or more, or a WPI score of 4 to 6 and an SS score of 9 or more.
- Symptoms were present at a similar level for a minimum of 3 months.
- No other condition accounts for the patient's pain
Who cannot join
- had other rheumatologic, musculoskeletal, or neurological disorders or any diseases that cause cognitive abnormality or
- had any contraindications to TENS.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical therapy outpatient clinics and Rheumatology clinic at Al Kasr Al Ainy Hospital
Cairo, Non US Or Canada
About this study
Official title: Effect of Adding Neuromodulation Technique to Cognitive Behavior Therapy on Fibromyalgia in Postmenopausal Women
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
Read more
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).
Read the detailed description
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).
- Conditions
- Fibromyalgia
- Being tested
- TENS, Cognitive behavior therapy, medical treatment
- Keywords
- Fibromyalgia, Cognitive behavioral therapy, TENS, pain, heart rate variability, quality of life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called Transcutaneous Electrical Nerve Stimulation
Name: Transcutaneous Electrical Nerve Stimulation (TENS). Type: device
Cognitive behavior therapyBehavioural
Also called CBT
Type: Behavioral Name: Cognitive Behavioral Therapy (CBT)
medical treatmentDrug
Also called (acetaminophen, duloxetine)
Type: Drug Name: Medical treatment (acetaminophen, duloxetine)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: medical treatment |
| Group (B) | Active comparator | Group (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks. Receives: Behavioral: Cognitive behavior therapy; Drug: medical treatment |
| Group (C) | Experimental | Group (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks. Receives: Device: TENS; Behavioral: Cognitive behavior therapy; Drug: medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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 .
Measured: Baseline and after 12 weeks
Assessment of pain threshold
A pressure algometer was used to deliver pressure pain on a skin area of 1 cm2 between the thumb and index finger
Measured: 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
Measured: 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.
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Sep 2022
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Mohamed Mohamdeen Ali Mohamed, Cairo University
- Investigators
- Enas Abd Elazim, Dr., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533487
- Sponsor's protocol ID
- P.T.REC/012/004339
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Neuromodulation Technique to Cognitive Behavior Therapy on Fibromyalgia in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07533487
- Acronym / sponsor ID
- P.T.REC/012/004339
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Cognitive behavioral therapy, TENS, pain, heart rate variability, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Drug: medical treatmentGroup (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 | Behavioral: Cognitive behavior therapy, Drug: medical treatmentGroup (B) received the same medical treatment, in addition to CBT, for two sessions per week for 12 weeks. |
| Group (C) | Experimental | Device: TENS, Behavioral: Cognitive behavior therapy, Drug: medical treatmentGroup (C) received the same treatment as group (B) and low TENS three times per week for 12 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female patients aged 50-60 years old
- body mass index (BMI) between 25 and 29.9 kg/m2
- patients meeting the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia syndrome, including a widespread pain index (WPI) score of 7 or more, a symptom severity (SS) score of 5 or more, or a WPI score of 4 to 6 and an SS score of 9 or more.
- Symptoms were present at a similar level for a minimum of 3 months.
- No other condition accounts for the patient's pain
Key exclusion criteria (2 listed)
- had other rheumatologic, musculoskeletal, or neurological disorders or any diseases that cause cognitive abnormality or
- had any contraindications to TENS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSAlso: Transcutaneous Electrical Nerve StimulationName: Transcutaneous Electrical Nerve Stimulation (TENS). Type: device | Device | Group (C) |
| Cognitive behavior therapyAlso: CBTType: Behavioral Name: Cognitive Behavioral Therapy (CBT) | Behavioural | Group (B), Group (C) |
| medical treatmentAlso: (acetaminophen, duloxetine)Type: Drug Name: Medical treatment (acetaminophen, duloxetine) | Drug | Group (A), Group (B), Group (C) |
Primary outcome
Assessment of the pain distribution
Time frame: 12 weeks
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.
4 secondary outcomes
Symptom Severity Scale (SSI)
Time frame: Baseline and after 12 weeks
Assessment of pain threshold
Time frame: Baseline and after 12 weeks
Assessment of heart rate variability (HRV)
Time frame: Baseline and after 12 weeks
Assessment of fibromyalgia symptoms
Time frame: Baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas Abd Elazim, Dr. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS, Cognitive behavior therapy and medical treatment in people with Fibromyalgia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the pain distribution (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.