To compare the effects of myofascial release technique on pain and quality of life in patients with fibromyalgia.
Design
Randomized Controlled Trial; single-blinded; on 110 samples; parallel groups; randomized by computer-generated method and further concealed envelop method used for allocation in the group. In the envelope, 1 will be code for the control group and 2 will be code for the experimental group.
Settings and conduct
The study will be conducted at the department of Physiotherapy, Nishtar Hospital, Multan.
The study will be single-blinded. The assessor will unaware of the treatment given to either group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Both gender.
Age between 20-40 years.
Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology.
History of wide spread chronic pain for more than 3 months.
Patient must exhibit more than 11 of 18 tender point.
Exclusion Criteria:
The cognitive deficit that does not allow the understanding of the evaluation instruments.
The physical activity started or changed in the last three months.
Intervention groups
Intervention group: Myofascial mobilization with routine physical therapy in the intervention group. The participants executed a 12-week supervised strengthening exercise program of 40-minute sessions performed twice a week, with progressive overload. In the first two sessions, no load was used. Subsequently, 0.5kg was added each week if the patient identified the effort as slightly intense on the Borg scale (score = 13)22. Control group: Routine physical therapy.
Main outcome variables
Pain; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210321050752N1
Registration date:2023-02-20, 1401/12/01
Registration timing:registered_while_recruiting
Last update:2023-02-20, 1401/12/01
Update count:0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
Muhammad Waqas
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 36532841
Email address
drwaqasfayyaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-02, 1401/10/12
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of myofascial release technique on pain and quality of life in patient of fibromyalgia: a randomised controlled trial
Public title
Myofascial release technique on pain and quality of life in patient of fibromyalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both gender
Age between 20-40 years
Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology
History of widespread chronic pain for more than 3 months
The patient must exhibit more than 11 of 18 tender point
Exclusion criteria:
Cognitive deficit that does not allow the understanding of the evaluation instruments
Physical activity started or changed in the last three months
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized by using the computer-generated method and further concealed envelop method is used for allocation in the group. In the envelop, 1 will be code for the control group and 2 will be code for the experimental group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor will only assess the patient at baseline and after follow-up for treatment outcomes. Assessor safe the data for follow-up and will not share it with any therapist or patient. At any stage, the assessor is unaware of the treatment and control group. The study was single-blinded. The assessor was unaware of the treatment given to either groups 1 or 2.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The rules and regulations set by the ethical committee of The University of Lahore wIll be followed
Data will be calculated at baseline, 1st follow up at 8th week and 2nd follow up at 16th week.
Method of measurement
● Numeric pain rating scale to measure pain
2
Description
Quality of life
Timepoint
Data will be calculated at baseline, 1st follow up at 8th week and 2nd follow up at 16th week
Method of measurement
WHO Quality of life questionnaire used to assess quality of life.
Secondary outcomes
empty
Intervention groups
1
Description
Group B: Myofascial mobilization with routine physical therapy: The participants executed a 12-week supervised myofascial mobilization program of 40-minute sessions performed twice a week.
Category
Rehabilitation
2
Description
Group A: Routine physical therapy: The routine physical therapy group underwent a 12-week supervised exercise program of 40- minute sessions performed thrice a week. Stretching and strengthening exercises. TENS units, ultrasound are applied on participant. The targeted muscles for stretching were: gluteus, iliopsoas, ischiotibials, paravertebralis, latissimus dorsi, hip adductor muscles, trapezium and pectoralis. At early stages of the program, participants performed three repetitions; from the fifth week, four repetitions; and from the ninth week, five. The stretch intensity were increased gradually to the point of moderate discomfort and the position was held for 30 seconds. Myofascial mobilization release will be given before every session of stretching exercise. Readings will be taken at baseline, 6th or 12th week of interventionThe participants executed a 12-week supervised strengthening exercise program of 40-minute sessions performed twice a week, with progressive overload. In the first two sessions, no load was used. Subsequently, 0.5kg was added each week if the patient identified the effort as slightly intense on the Borg scale (score = 13)22.The patients were instructed to do a series of eight repetitions of strengthening exercises for the following muscles23: triceps surae, hip adductors and abductors, hip flexor, shoulder flexor and extensor, anterior and posterior deltoids, pectoralis major and rhomboids
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physiotherapy, Nishtar Hospital, Multan
Full name of responsible person
Dr Talha Qazi
Street address
Nishter hospital Multan
City
Multan
Postal code
60000
Phone
+92 300 6334647
Email
drmtq106@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Self Supported
Full name of responsible person
Noureen Mazhar
Street address
Multan
City
Multan
Postal code
6000
Phone
+92 304 1879622
Email
noreensipra@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Self Supported
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
The University of Lahore
Full name of responsible person
Muhammad Waqas
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Numeric pain rating scale will be used for the assessment of pain.
WHO Quality of life questionnaire will be used to assess the quality of life.
When the data will become available and for how long
6 months after publication.
To whom data/document is available
academic and clinical research writers.
Under which criteria data/document could be used
Never without permission.
From where data/document is obtainable
From Muhammad Waqas through mail id.
drwaqasfayyaz@gmail.com
or through a Researchgate account.
https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf
What processes are involved for a request to access data/document
From Muhammad Waqas through mail id.
drwaqasfayyaz@gmail.com
or through a Researchgate account.
https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf