1. To check efficacy of active segmental stretching and 30-minute walking on pain reduction.
2. To check life’s quality in fibromyalgia patients.
Design
A parallel group, single blinded, randomized controlled trial conducted on 62 females diagnosed with fibromyalgia between August to November 2022 with a 6 week follow up.
Settings and conduct
This study was conducted in orthopedic department of Aziz Bhatti THQ hospital, Gujrat
Data analyser is only blinded in our study because he does not know which and how interventional exercises were performed by patients.
Participants/Inclusion and exclusion criteria
Inclusion:
Female from 20 to 65 year old diagnosed with fibromyalgia in outpatient/inpatient clinics or by America College of Rheumatology Criteria in general population.
Exclusion:
Joint disorders (Grade 4 arthritis, hip or knee arthroplasty, rheumatoid arthritis) that can cause hindrance in the exercise program.
Respiratory diseases or cardiovascular diseases (heart failure, cardiac pacemaker, uncontrolled arterial hypertension) that would prevent physical exercise.
Pregnant and post-partum women.
Intervention groups
Active segmental stretching group:
Participants undergone through a 6-week supervised exercise program involving active segmental stretching of muscles mostly involving large muscles (paravertebral, gluteus, quadricep, hip abductor, latissmus dorsi, pectoral, trapezius and calf stretches). Each exercise was held for 30 seconDS
30- minute walking group:
participants only undergo 30 min of brisk walk in bouts of 15 minute with no other specific exercises or
Each intervention was done thrice a week for first three weeks and four time per week for the next three weeks
Main outcome variables
Fibromyalgia impact questionnaire-revised (FIQR) for symptoms and impact of Fibromyalgia
Numeric pain rating scale for pain
SF-12 for quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221205056715N1
Registration date:2022-12-21, 1401/09/30
Registration timing:retrospective
Last update:2022-12-21, 1401/09/30
Update count:0
Registration date
2022-12-21, 1401/09/30
Registrant information
Name
Mubashra Warriach
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 331 6258175
Email address
warriachmubashra@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-05, 1401/05/14
Expected recruitment end date
2022-11-30, 1401/09/09
Actual recruitment start date
2022-08-15, 1401/05/24
Actual recruitment end date
2022-11-15, 1401/08/24
Trial completion date
2022-11-20, 1401/08/29
Scientific title
Effectiveness of active segmental stretching and 30-minute walking on fibromyalgia symptoms reduction in female
Public title
Effectiveness of active segmental stretching and 30-minute walking on fibromyalgia symptoms reduction in female
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 65 years females
Participants diagnosed with fibromyalgia in outpatient/inpatient clinics or diagnosed by American College of Rheumatology Criteria in general population.
Written informed consent was considered necessary from study participants to enable them to take part.
Exclusion criteria:
joint disorders (Grade 4 arthritis, hip or knee arthroplasty, rheumatoid arthritis) that can cause hindrance in the exercise program
respiratory diseases or cardiovascular diseases that would prevent physical exercise
pregnant and post-partum women
recent modifications to FM therapy such as pyschotherapy
Age
From 20 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
62
Actual sample size reached:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling method was used with individual randomization unit. Randomization is done by computer software. Patients were haphazardly placed in either of 2 interventional group with 31 fibromyalgia patient in each. no allocation concealment was done
Blinding (investigator's opinion)
Single blinded
Blinding description
data analyser is blinded in my study because he does not know anything about patients being randomized into any group and he also does not know which exercises are performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Lahore
Street address
Shadman colony, Defense block, street 1, Gujrat
City
Gujrat
Postal code
50700
Approval date
2022-08-15, 1401/05/24
Ethics committee reference number
REG/GRT/22/AHS-81
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
Fibromyalgia symptom reduction
Timepoint
Baseline, 3rd week and 6th week
Method of measurement
Fibromyalgia impact questionnaire-revised (FIQR)
Secondary outcomes
1
Description
Pain
Timepoint
baseline, 3rd week and 6th week
Method of measurement
Numeric pain rating scale(NPRS)
2
Description
Quality of life
Timepoint
baseline, 3rd week and 6th week
Method of measurement
SF-12 Health survey questionnaire
Intervention groups
1
Description
Intervention group: Active segmental stretching exercises should be performed to patients thrice a week for 1st 3 weeks and 4 times a week for the last 3 weeks. Exercises include trapezius, pectoral, calfs, gluteal and many other stretches of large muscles.
Category
Rehabilitation
2
Description
Intervention group: 30 minute walking thrice a week from baseline to 3rd week, further frequency increases from 4 times a week for last 3 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Lahore
Full name of responsible person
Mubashra Maqsood
Street address
Shadman colony, Defense block, street 1, Gujrat
City
Gujrat
Postal code
50700
Phone
+92 331 6258175
Email
warriachmubashra@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of lahore
Full name of responsible person
Mubashra maqsood
Street address
street 1 defense block shadman colony gujrat
City
gujrat
Postal code
50700
Phone
+92 331 6258175
Email
warriachmubashra@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of lahore
Proportion provided by this source
100
Public or private sector
Private
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
University of Lahore
Full name of responsible person
Mubashra Maqsood
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shadman colony, defense block street 1, Gujrat
City
Gujrat
Province
Punjab
Postal code
50700
Phone
+92 331 6258175
Email
warriachmubashra@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Mubashra Maqsood
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shadman colony, defense block street 1, Gujrat
City
Gujrat
Province
Punjab
Postal code
50700
Phone
+92 331 6258175
Email
warriachmubashra@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Mubashra Maqsood
Position
consultant
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shadman colony, defense block street 1, Gujrat
City
Gujrat
Province
Punjab
Postal code
50700
Phone
+92 331 6258175
Email
warriachmubashra@gmail.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effectiveness of active segmental stretching and 30 minute walking on fibromyalgia symptom reduction
When the data will become available and for how long
after publication
To whom data/document is available
to all acadamic and working insititutions
Under which criteria data/document could be used
for rehabilitation purposes
From where data/document is obtainable
from researcher
What processes are involved for a request to access data/document