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

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ClinicalTrials.gov Identifier: NCT04674878
Recruitment Status : Completed
First Posted : December 19, 2020
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Riphah International University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: METs Other: Breathing exercise group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Muscle Energy Techniques (METS) With Breathing Exercises to Improve Functional Outcomes in Patients of Fibromyalgia.
Actual Study Start Date : September 25, 2020
Actual Primary Completion Date : January 15, 2021
Actual Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MET group
METs for accessory muscles of respiration including sternocleidomastoid, scalenes and trapezius given thrice a week for 8 weeks.
Other: METs
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.
Other: Breathing exercise group
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 Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. 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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674878


Locations
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Pakistan
Riphah International University
Rawalpindi, Federal, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Suman Sheraz, PhD* Riphah International University
Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04674878    
Other Study ID Numbers: REC/00705 Saira Zahid
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Diaphragmatic breathing
Fibromyalgia
Muscle energy techniques
Breathing exercises
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Respiratory Aspiration
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes