- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04674878
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia (MET)
March 21, 2021 updated by: Riphah International University
Comparison of Muscle Energy Techniques (METS) With Breathing Exercises to Improve Functional Outcomes in Patients of Fibromyalgia.
This study is planned to compare the effects of Muscle Energy Techniques (MET) with breathing exercises for improving functional outcomes in patients with fibromyalgia.
A randomized controlled trial will be conducted.
Sample size would be 26 patients with fibromyalgia randomly allocated to the Muscle energy techniques group and breathing exercise group.
Both the groups will receive 8 weeks of treatment, 3 times per week.
Data will be collected at baseline 5th week and 8th week.
Outcome measurements include a Numeric pain rating scale, 6 min walk test, chest expansion, Pittsburgh sleep quality index, and Fibromyalgia Impact Questionnaire scores.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fibromyalgia (FM) is a common syndrome characterized by widespread pain and at least 11/18 painful tender points (American College of Rheumatology).
Fibromyalgia syndrome (FMS) is a rheumatic condition of increasing prevalence worldwide) approximately 2-7% of the populations are affected.
Some of the symptoms associated with fibromyalgia is sleep disturbance, dizziness, headache, fatigue, depression/tension, pain, cognitive disorder, irritable bowel syndrome, and different somatic symptoms.
These factors negatively influence physical and emotional characteristics and decrease the quality of life.
Fatigue and dyspnea are the significant signs and symptoms of fibromyalgia, which can be related to respiratory system changes.
Major affected areas in fibromyalgia include breathing mechanics, the upper trapezius muscle, the cervical muscle mass, the scalene, Sternocleidomastoid, and the area around the second rib and all the paravertebral muscle mass.
These regions are coordinated with the tender points placed in the upper half body of patients with FM.
Fibromyalgia patients, without a doubt, exhaust and come to be fatigue due to the dyspnea.
It is widespread among females; however, it can additionally affect both men and teenagers.
Many pharmacological therapies were being used to treat FM with uncertain consequences, and steadily growing small doses are usually recommended to maximize efficacy.
Among non pharmacological management including exercise is typically endorsed in the management of patients with fibromyalgia.
Regular workout is an essential keystone of fibromyalgia management.
Aerobic workout interventions have shown reduced ache, depression, and fatigue, improving health-related quality of life (HRQOL).
Related literature includes meta-analysis regarding the exercise effects (endurance, aerobic, or mixed aerobic and strength workout) on worldwide welfare in people with fibromyalgia.
Breathing issues tend to intensify FM symptoms.
The FM patients exhaust quickly, and dyspnea causes fatigue related to respiratory muscle weakness, mainly diaphragmatic deficiency, that can decrease the physical condition and capability inside the daily activities.
Breathing exercises have been proven to be useful in decreasing symptoms of FM.
MET is the osteopathic manipulation strategies of the tender tissues that evolved to recover the musculoskeletal system's function and decrease pain.
Both these techniques have proven effects for reduction of symptoms in FM patients.
This study is intended to compare the effects of both in order to find out the technique that can effectively improve the functional outcomes in patients with fibromyalgia.
Study Type
Interventional
Enrollment (Actual)
26
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 Locations
-
-
Federal
-
Rawalpindi, Federal, Pakistan, 44000
- Riphah International 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 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- American College of Rheumatology's criteria of fibromyalgia will be used
Exclusion Criteria:
- Smokers
- Severe spinal injuries
- Inflammatory rheumatic disease
- Patients diagnosed with pulmonary Disease
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MET group
METs for accessory muscles of respiration including sternocleidomastoid, scalenes and trapezius given thrice a week for 8 weeks.
|
The isometric contraction of 7 sec will be applied followed by a stretching of 30 sec in painless range.
This treatment will be given to the both sides of the neck targeting the three major accessory muscles of respiration.
|
Active Comparator: Breathing exercise group
Diaphragmatic breathing, pursed lip breathing and diaphragmatic breathing with resistance given thrice a week for 8 weeks.
|
Three exercises will be performed in a circuit, 2 circuits in every session.
It will include diaphragmatic breathing exercise in which patient will be in supine position inhaling through nose and expiration through moth with half closed lips.
Second exercise pursed lip breathing also in supine position with the hands on abdomen and then inspiration through nose and expiration through mouth with half closing of lips.
Third exercise resisted diaphragmatic breathing also in same pattern as second exercise with an addition of 1 kg weight on abdomen.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale for pain (NPRS)
Time Frame: 8 weeks
|
The Numeric Pain Rating Scale is a subjective measure, in which individuals rate their pain on an eleven point numeric scale.
The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibromyalgia impact questionnaire (FIQ)
Time Frame: 4 and 8 weeks
|
The Fibromyalgia Impact Questionnaire is an assessment and evaluation instrument developed to measure fibromyalgia patient status, progress and functional capacity.
It has been designed to measure the components of health status that are believed to be the most affected by FM.
|
4 and 8 weeks
|
6 Minute walk test (6MWT)
Time Frame: 4 and 8 weeks
|
The 6-min walk test is a submaximal exercise test that entails measurement of distance walk over a span of 6 min.
The 6-minute walk distance provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
|
4 and 8 weeks
|
Pittsburgh sleep Quality Index (PSQI)
Time Frame: 4 and 8 weeks
|
The Pittsburgh Sleep Quality Index is a self-report questionnaire assesses sleep quality over a 1-month time interval.
The measure consists of 19 individual items, creating 7 components that produces one global score and takes 5-10 minutes to complete.
|
4 and 8 weeks
|
Measuring tape for the thoracoabdominal mobility indices
Time Frame: 4 and 8 weeks
|
Measuring tape is used to measure thoracoabdominal expansion at three levels which are Axilla, Xiphoid and Navel.
|
4 and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
- Forti M, Zamuner AR, Andrade CP, Silva E. Lung Function, Respiratory Muscle Strength, and Thoracoabdominal Mobility in Women With Fibromyalgia Syndrome. Respir Care. 2016 Oct;61(10):1384-90. doi: 10.4187/respcare.04401. Epub 2016 Apr 19.
- Imamura M, Cassius DA, Fregni F. Fibromyalgia: From treatment to rehabilitation. Eur J Pain. 2009 Nov 1;3(2):117-122. doi: 10.1016/j.eujps.2009.08.011.
- Sim J, Adams N. Systematic review of randomized controlled trials of nonpharmacological interventions for fibromyalgia. Clin J Pain. 2002 Sep-Oct;18(5):324-36. doi: 10.1097/00002508-200209000-00008.
- Sarzi-Puttini P, Atzeni F, Salaffi F, Cazzola M, Benucci M, Mease PJ. Multidisciplinary approach to fibromyalgia: what is the teaching? Best Pract Res Clin Rheumatol. 2011 Apr;25(2):311-9. doi: 10.1016/j.berh.2011.03.001.
- Garrido M, Castano MY, Biehl-Printes C, Gomez MA, Branco JC, Tomas-Carus P, Rodriguez AB. Effects of a respiratory functional training program on pain and sleep quality in patients with fibromyalgia: A pilot study. Complement Ther Clin Pract. 2017 Aug;28:116-121. doi: 10.1016/j.ctcp.2017.05.013. Epub 2017 May 28.
- Tomas-Carus P, Branco JC, Raimundo A, Parraca JA, Batalha N, Biehl-Printes C. Breathing Exercises Must Be a Real and Effective Intervention to Consider in Women with Fibromyalgia: A Pilot Randomized Controlled Trial. J Altern Complement Med. 2018 Aug;24(8):825-832. doi: 10.1089/acm.2017.0335. Epub 2018 Apr 13.
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 (Actual)
September 25, 2020
Primary Completion (Actual)
January 15, 2021
Study Completion (Actual)
January 20, 2021
Study Registration Dates
First Submitted
December 16, 2020
First Submitted That Met QC Criteria
December 17, 2020
First Posted (Actual)
December 19, 2020
Study Record Updates
Last Update Posted (Actual)
March 23, 2021
Last Update Submitted That Met QC Criteria
March 21, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00705 Saira Zahid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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