Clinical trial NCT04674878: Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
Official title: Comparison of Muscle Energy Techniques (METS) With Breathing Exercises to Improve Functional Outcomes in Patients of Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Diaphragmatic breathing
Fibromyalgia
Muscle energy techniques
Breathing exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 26
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric Pain Rating Scale for pain (NPRS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Fibromyalgia impact questionnaire (FIQ)
timeFrame: 4 and 8 weeks
measure: 6 Minute walk test (6MWT)
timeFrame: 4 and 8 weeks
measure: Pittsburgh sleep Quality Index (PSQI)
timeFrame: 4 and 8 weeks
measure: Measuring tape for the thoracoabdominal mobility indices
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Suman Sheraz, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.