FibromyalgiaNCT05786677
Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
A study testing Physiotherapy protocol and Selective serotonin reuptake inhibitors (SSRI) in people with Fibromyalgia and Depression, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of his study is to investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Depression
- What is being tested?
- Physiotherapy protocol and Selective serotonin reuptake inhibitors (SSRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 15 Aug 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fibromyalgia patients will be included if they meet the diagnosis of FM according to the American College Rheumatology (ACR), diagnosed with depression and referred by a physician.
- Patients diagnosed with mild and moderate forms of major depression.
- Their ages range from 20- 60 years old.
- Patients willing and able to participate in a physiotherapy program and capable of doing physical exercise on their own.
Who cannot join
- severe spinal injuries
- severe musculoskeletal abnormalities
- inflammatory rheumatic diseases
- respiratory or cardiac pathologies
- Any vestibular, visual or neurological dysfunction affecting balance.
- History of suicidal attempts
- Severe depression
- Suffering from severe somatic or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Mahitab Momen contact
About this study
The purpose of his study is to investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.
Read the detailed description
This study will investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.
- Conditions
- Fibromyalgia, Depression
- Being tested
- Physiotherapy protocol, Selective serotonin reuptake inhibitors (SSRI)
- Medical subject headings
- Fibromyalgia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy protocolOther
the physiotherapy protocol which will include: 4. Exercise in the form of: d. Breathing exercise e. Aerobic exercise (walking on treadmill with a speed of 3 miles per hour and 0% inclination) f. Bridging exercise 5. Manual techniques in the form of:
- Suboccipital release
- Diaphragm release
- Clavi-pectoral myofascial release 6. Home Routine
- Hot tub bath for 30 minutes d. Breathing exercise
Selective serotonin reuptake inhibitors (SSRI)Drug
Selective serotonin reuptake inhibitors (SSRIs)
| Study group | Role | What they receive |
|---|---|---|
| Patients with fibromyalgia and depression (1) | Experimental | Patients in this group will receive physiotherapy protocol and medications. Receives: Other: Physiotherapy protocol; Drug: Selective serotonin reuptake inhibitors (SSRI) |
| Patients with fibromyalgia and depression (2) | Active comparator | Patients in this group will receive medications only. Receives: Drug: Selective serotonin reuptake inhibitors (SSRI) |
| Patients with depression only (1) | Experimental | Patients in this group will receive physiotherapy protocol and medications. Receives: Other: Physiotherapy protocol; Drug: Selective serotonin reuptake inhibitors (SSRI) |
| Patients with depression only (2) | Active comparator | Patients in this group will receive medications only. Receives: Drug: Selective serotonin reuptake inhibitors (SSRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in severity of respondents' depression
Assessment will be done by using Arabic version of Beck Depression Inventory (BDI) which is designed to rate the severity of respondents' depression in the weeks preceding questionnaire completion. Each of the 21 questions presents four different statements and asks respondents to select the option that best represents them. Statements refer to depressive states in varying degrees of severity (from "I do not feel sad" to "I am so sad or unhappy that I can't stand it"), and this is reflected in the scoring process which assigns higher values to responses indicating more acute symptoms of depression. The total score can range from 0 to 63 points, with a total score of 0-9 points indicating minimal depression, 10-18 points mild, 19-29 points moderate, and 30-63 points severe depression.
Measured: at baseline, after 2 weeks of intervention, after 4 weeks of intervention and after one month and two months of end of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahitab Momen Gamal-Eldien Elansary, Cairo University
- Investigators
- Mahitab Momen, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786677
- Sponsor's protocol ID
- Mahitab_2023
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
- ClinicalTrials.gov ID
- NCT05786677
- Acronym / sponsor ID
- Mahitab_2023
- Conditions
- Fibromyalgia, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 27 Mar 2023 (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 purpose of his study is to investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.
Detailed description
This study will investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with fibromyalgia and depression (1) | Experimental | Other: Physiotherapy protocol, Drug: Selective serotonin reuptake inhibitors (SSRI)Patients in this group will receive physiotherapy protocol and medications. |
| Patients with fibromyalgia and depression (2) | Active comparator | Drug: Selective serotonin reuptake inhibitors (SSRI)Patients in this group will receive medications only. |
| Patients with depression only (1) | Experimental | Other: Physiotherapy protocol, Drug: Selective serotonin reuptake inhibitors (SSRI)Patients in this group will receive physiotherapy protocol and medications. |
| Patients with depression only (2) | Active comparator | Drug: Selective serotonin reuptake inhibitors (SSRI)Patients in this group will receive medications only. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fibromyalgia patients will be included if they meet the diagnosis of FM according to the American College Rheumatology (ACR), diagnosed with depression and referred by a physician.
- Patients diagnosed with mild and moderate forms of major depression.
- Their ages range from 20- 60 years old.
- Patients willing and able to participate in a physiotherapy program and capable of doing physical exercise on their own.
Key exclusion criteria (8 listed)
- severe spinal injuries
- severe musculoskeletal abnormalities
- inflammatory rheumatic diseases
- respiratory or cardiac pathologies
- Any vestibular, visual or neurological dysfunction affecting balance.
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 |
|---|---|---|
| Physiotherapy protocolthe physiotherapy protocol which will include: 4. Exercise in the form of: d. Breathing exercise e. Aerobic exercise (walking on treadmill with a speed of 3 miles per hour and 0% inclination) f. Bridging exercise 5. Manual techniques in the form of: 1. Suboccipital release 2. Diaphragm release 3. Clavi-pectoral myofascial release 6. Home Routine c. Hot tub bath for 30 minutes d. Breathing exercise | Other | Patients with depression only (1), Patients with fibromyalgia and depression (1) |
| Selective serotonin reuptake inhibitors (SSRI)Selective serotonin reuptake inhibitors (SSRIs) | Drug | Patients with depression only (1), Patients with depression only (2), Patients with fibromyalgia and depression (1), Patients with fibromyalgia and depression (2) |
Primary outcome
Assessing the change in severity of respondents' depression
Time frame: at baseline, after 2 weeks of intervention, after 4 weeks of intervention and after one month and two months of end of treatment period
Assessment will be done by using Arabic version of Beck Depression Inventory (BDI) which is designed to rate the severity of respondents' depression in the weeks preceding questionnaire completion. Each of the 21 questions presents four different statements and asks respondents to select the option that best represents them. Statements refer to depressive states in varying degrees of severity (from "I do not feel sad" to "I am so sad or unhappy that I can't stand it"), and this is reflected in the scoring process which assigns higher values to responses indicating more acute symptoms of depression. The total score can range from 0 to 63 points, with a total score of 0-9 points indicating minimal depression, 10-18 points mild, 19-29 points moderate, and 30-63 points severe depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Mahitab Momen contact
Mahitab Momen 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 Physiotherapy protocol and Selective serotonin reuptake inhibitors (SSRI) in people with Fibromyalgia and Depression, 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahitab Momen (010226960790, bobapt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in severity of respondents' depression (time frame: at baseline, after 2 weeks of intervention, after 4 weeks of intervention and after one month and two months of end of treatment period). 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 27 Mar 2023.