Back to resultsEffect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
Primary Purpose
Fibromyalgia, Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Physiotherapy protocol
Selective serotonin reuptake inhibitors (SSRI)
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Outpatient clinic faculty of physica therapy cairo university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Patients with fibromyalgia and depression (1)
Patients with fibromyalgia and depression (2)
Patients with depression only (1)
Patients with depression only (2)
Arm Description
Patients in this group will receive physiotherapy protocol and medications.
Patients in this group will receive medications only.
Patients in this group will receive physiotherapy protocol and medications.
Patients in this group will receive medications only.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05786677
Brief Title
Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
Official Title
Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with fibromyalgia and depression (1)
Arm Type
Experimental
Arm Description
Patients in this group will receive physiotherapy protocol and medications.
Arm Title
Patients with fibromyalgia and depression (2)
Arm Type
Active Comparator
Arm Description
Patients in this group will receive medications only.
Arm Title
Patients with depression only (1)
Arm Type
Experimental
Arm Description
Patients in this group will receive physiotherapy protocol and medications.
Arm Title
Patients with depression only (2)
Arm Type
Active Comparator
Arm Description
Patients in this group will receive medications only.
Intervention Type
Other
Intervention Name(s)
Physiotherapy protocol
Intervention Description
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
c. Hot tub bath for 30 minutes d. Breathing exercise
Intervention Type
Drug
Intervention Name(s)
Selective serotonin reuptake inhibitors (SSRI)
Intervention Description
Selective serotonin reuptake inhibitors (SSRIs)
Primary Outcome Measure Information:
Title
Assessing the change in severity of respondents' depression
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahitab Momen
Phone
010226960790
Email
bobapt@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mahitab Momen
Email
bobapt@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahitab Momen
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physica therapy cairo university
City
Dokki
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
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