Determining the effectiveness of stretching exercises on the effect of the disease and quality of life in patients with fibromyalgia undergoing drug treatment
Design
Randomized clinical trial with control group with parallel groups and impossibility of blinding on 50 patients with fibromyalgia
Settings and conduct
Medical clinics of Mazandaran University of Medical Sciences / Patients are identified by a rheumatologist and referred to a psychiatric clinic and then to a sports medicine clinic for intervention.The intervention group is trained in static stretching exercises by a sports medicine specialist. Every week during the phone call, the process of doing exercises, possible complications and stopping criteria are checked. Patients fill in their sports logbook for each session.Questionnaire are completed in weeks 0, 5 and 10.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who have been diagnosed by a rheumatologist and are being treated with Sertraline or Fluoxetine or ِDuloxetine/Female gender/Age over 18 years/Have consent to participate in the study/Be literate/Lack of suicidal thoughts/Do not take corticosteroids/No secondary fibromyalgia/Not participating in another clinical trial in the last six months/Do not have heart disease,uncontrolled blood pressure and diabetes and other rheumatic diseases/Failure to start with any neurological, metabolic or orthopedic problems prevents all sports-related sports/Not abusing drugs, cigarettes and other substances according to the statement of the person or companion/Not pregnant or breastfeeding/A maximum of 3 months have passed since the start of drug treatment and drug treatment remains constant during the plan
Effectiveness of educating stretching exercise on impact and Quality of Life in Patients on drug therapy with Fibromyalgia
Public title
Effectiveness of educating stretching exercise on impact and Quality of Life in Patients on drug therapy with Fibromyalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with fibromyalgia diagnosed by a rheumatologist, referred to a psychiatric clinic and treated with sertraline or fluoxetine or duloxetine
Female gender
Age over 18 years
Have consent to participate in the study.
Be literate
Lack of suicidal thoughts
Do not take corticosteroids
No secondary fibromyalgia
Not participating in another clinical trial in the last six months
Do not have heart disease, uncontrolled blood pressure and diabetes and other rheumatic diseases
Not to have any neurological, metabolic or orthopedic problems prevents all sports-related sports
Not abusing drugs, cigarettes and other substances according to the statement of the person or companion
Not pregnant or breastfeeding
A maximum of 3 months have passed since the start of drug treatment and drug treatment remains constant during the plan
Exclusion criteria:
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients according to the inclusion criteria are assigned to the following blocks, respectively (assuming the presence of 14 new patients per month): so that the first and second person according to the blocks are part of the intervention group and the third and fourth person are control group and similarly random Making is done. The last block is less and the cause of randomization is the homogenization of the two groups in terms of number.
0001: Case 0005: Placebo 0009: Case 0013: Placebo
0002: Case 0006: Placebo 0010: Case 0014: Placebo
0003: Placebo 0007: Case 0011: Case
0004: Placebo 0008: Case 0012: Placebo
__________________________________________
0015: Case 0019: Placebo 0023: Case 0027: Placebo
0016: Case 0020: Case 0024: Placebo 0028: Placebo
0017: Case 0021: Placebo 0025: Placebo
0018: Case 0022: Placebo 0026: Case
__________________________________________
0029: Placebo 0032: Placebo 0035: Case 0038: Case
0030: Case 0033: Placebo 0036: Case 0039: Placebo
0031: Case 0034: Placebo 0037: Placebo 0040: Case
0041: Case 0042: Placebo
__________________________________________
0043: Case 0045: Case 0047: Placebo 0049: Case
0044: Placebo 0046: Case 0048: Placebo 0050: Placebo
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Fanavarihaye Novin University, next to Bagheban clinic, Shahid beheshti boulevard
City
Sari
Province
Mazandaran
Postal code
4816895475
Approval date
2020-12-02, 1399/09/12
Ethics committee reference number
IR.MAZUMS.REC.1399.780
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
Quality of Life
Timepoint
0,5,10 weeks
Method of measurement
SF-36 questionnaire
2
Description
Effect of fibromyalgia
Timepoint
0,5,10 weeks
Method of measurement
Fibromyalgia Impact Questionnaire (FIQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: exercise therapy. 5-week period, static stretching exercises including neck flexor & extensor stretch, wrist extensor stretching, hip abductor stretch, gluteus maximus stretch, hip adductor stretch and piriformis stretching (taken from the book Rehabilitation techniques for sports medicine and athletic training-6th edition.William E Prentice). Each movement 2 days a week and repeated 3 times, the first week 10 seconds and a 5 second increase in subsequent weeks (fifth week 30 seconds) and to the extent of feeling unwell
Category
Treatment - Other
2
Description
Control group: Pharmacotherapy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatologic Clinic and Sport Medicine Center of Imam Khomeini Hospital
Full name of responsible person
Zahra Madani
Street address
Sport Medicine Center , Mostafavian Clinic , 3th Ave, Razi St
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
z.madani@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Deputy of Research and Technology, Moallem Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Madani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 6 , Mostafavian Clinic , 3th Ave , Razi St
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
z.madani@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Madani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 6 , Mostafavian Clinic , 3th Ave , Razi St
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
z.madani@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zahra Madani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 6 , Mostafavian Clinic , 3th Ave , Razi St
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
z.madani@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available