Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study

March 24, 2023 updated by: Mahitab Momen Gamal-Eldien Elansary, Cairo University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Dokki, Egypt
        • Outpatient clinic faculty of physica therapy cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Patients diagnosed with mild and moderate forms of major depression.
  3. Their ages range from 20- 60 years old.
  4. Patients willing and able to participate in a physiotherapy program and capable of doing physical exercise on their own.

Exclusion Criteria:

  1. severe spinal injuries
  2. severe musculoskeletal abnormalities
  3. inflammatory rheumatic diseases
  4. respiratory or cardiac pathologies
  5. Any vestibular, visual or neurological dysfunction affecting balance.
  6. History of suicidal attempts
  7. Severe depression
  8. Suffering from severe somatic or psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with fibromyalgia and depression (1)
Patients in this group will receive physiotherapy protocol and medications.
Other: Physiotherapy protocol

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:

  1. Suboccipital release
  2. Diaphragm release
  3. Clavi-pectoral myofascial release 6. Home Routine

c. Hot tub bath for 30 minutes d. Breathing exercise

Drug: Selective serotonin reuptake inhibitors (SSRI)
Selective serotonin reuptake inhibitors (SSRIs)
Active Comparator: Patients with fibromyalgia and depression (2)
Patients in this group will receive medications only.
Drug: Selective serotonin reuptake inhibitors (SSRI)
Selective serotonin reuptake inhibitors (SSRIs)
Experimental: Patients with depression only (1)
Patients in this group will receive physiotherapy protocol and medications.
Other: Physiotherapy protocol

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:

  1. Suboccipital release
  2. Diaphragm release
  3. Clavi-pectoral myofascial release 6. Home Routine

c. Hot tub bath for 30 minutes d. Breathing exercise

Drug: Selective serotonin reuptake inhibitors (SSRI)
Selective serotonin reuptake inhibitors (SSRIs)
Active Comparator: Patients with depression only (2)
Patients in this group will receive medications only.
Drug: Selective serotonin reuptake inhibitors (SSRI)
Selective serotonin reuptake inhibitors (SSRIs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline, after 2 weeks of intervention, after 4 weeks of intervention and after one month and two months of end of treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mahitab Momen, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

June 15, 2023

Study Completion (Anticipated)

August 15, 2023

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mahitab_2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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