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Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia (MET)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
METs
Breathing exercise group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Diaphragmatic breathing, Fibromyalgia, Muscle energy techniques, Breathing exercises

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MET group

Breathing exercise group

Arm Description

METs for accessory muscles of respiration including sternocleidomastoid, scalenes and trapezius given thrice a week for 8 weeks.

Diaphragmatic breathing, pursed lip breathing and diaphragmatic breathing with resistance given thrice a week for 8 weeks.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale for pain (NPRS)
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).

Secondary Outcome Measures

Fibromyalgia impact questionnaire (FIQ)
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.
6 Minute walk test (6MWT)
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.
Pittsburgh sleep Quality Index (PSQI)
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.
Measuring tape for the thoracoabdominal mobility indices
Measuring tape is used to measure thoracoabdominal expansion at three levels which are Axilla, Xiphoid and Navel.

Full Information

First Posted
December 16, 2020
Last Updated
March 21, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04674878
Brief Title
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
Acronym
MET
Official Title
Comparison of Muscle Energy Techniques (METS) With Breathing Exercises to Improve Functional Outcomes in Patients of Fibromyalgia.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Diaphragmatic breathing, Fibromyalgia, Muscle energy techniques, Breathing exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MET group
Arm Type
Experimental
Arm Description
METs for accessory muscles of respiration including sternocleidomastoid, scalenes and trapezius given thrice a week for 8 weeks.
Arm Title
Breathing exercise group
Arm Type
Active Comparator
Arm Description
Diaphragmatic breathing, pursed lip breathing and diaphragmatic breathing with resistance given thrice a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
METs
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breathing exercise group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale for pain (NPRS)
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Fibromyalgia impact questionnaire (FIQ)
Description
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.
Time Frame
4 and 8 weeks
Title
6 Minute walk test (6MWT)
Description
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.
Time Frame
4 and 8 weeks
Title
Pittsburgh sleep Quality Index (PSQI)
Description
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.
Time Frame
4 and 8 weeks
Title
Measuring tape for the thoracoabdominal mobility indices
Description
Measuring tape is used to measure thoracoabdominal expansion at three levels which are Axilla, Xiphoid and Navel.
Time Frame
4 and 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Sheraz, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Rawalpindi
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21285161
Citation
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.
Results Reference
background
PubMed Identifier
27094397
Citation
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.
Results Reference
background
PubMed Identifier
20657807
Citation
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.
Results Reference
background
PubMed Identifier
12218504
Citation
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.
Results Reference
background
PubMed Identifier
22094204
Citation
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.
Results Reference
background
PubMed Identifier
28779918
Citation
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.
Results Reference
background
PubMed Identifier
29653069
Citation
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.
Results Reference
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Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia

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