FibromyalgiaMETNCT04674878
Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia
A study testing METs and Breathing exercise group in people with Fibromyalgia, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- METs and Breathing exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Sep 2020to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American College of Rheumatology's criteria of fibromyalgia will be used
Who cannot join
- Smokers
- Severe spinal injuries
- Inflammatory rheumatic disease
- Patients diagnosed with pulmonary Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- METs, Breathing exercise group
- Keywords
- Diaphragmatic breathing, Fibromyalgia, Muscle energy techniques, Breathing exercises
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METsOther
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.
Breathing exercise groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MET group | Experimental | METs for accessory muscles of respiration including sternocleidomastoid, scalenes and trapezius given thrice a week for 8 weeks. Receives: Other: METs |
| Breathing exercise group | Active comparator | Diaphragmatic breathing, pursed lip breathing and diaphragmatic breathing with resistance given thrice a week for 8 weeks. Receives: Other: Breathing exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 4 and 8 weeks
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.
Measured: 4 and 8 weeks
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.
Measured: 4 and 8 weeks
Measuring tape for the thoracoabdominal mobility indices
Measuring tape is used to measure thoracoabdominal expansion at three levels which are Axilla, Xiphoid and Navel.
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start25 Sep 2020
- Primary completion15 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674878
- Sponsor's protocol ID
- REC/00705 Saira Zahid
- Acronym
- MET
- Status last verified
- Mar 2021
- First submitted
- 16 Dec 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21285161Forti 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.
PubMed 27094397Imamura 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.
PubMed 20657807Sim 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.
PubMed 12218504Sarzi-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.
PubMed 22094204Garrido 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.
PubMed 28779918Tomas-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.
PubMed 29653069
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Muscle Energy Techniques (METS) With Breathing Exercises to Improve Functional Outcomes in Patients of Fibromyalgia.
- ClinicalTrials.gov ID
- NCT04674878
- Acronym / sponsor ID
- MET / REC/00705 Saira Zahid
- Conditions
- Fibromyalgia
- Keywords
- Diaphragmatic breathing, Fibromyalgia, Muscle energy techniques, Breathing exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MET group | Experimental | Other: METsMETs for accessory muscles of respiration including sternocleidomastoid, scalenes and trapezius given thrice a week for 8 weeks. |
| Breathing exercise group | Active comparator | Other: Breathing exercise groupDiaphragmatic breathing, pursed lip breathing and diaphragmatic breathing with resistance given thrice a week for 8 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American College of Rheumatology's criteria of fibromyalgia will be used
Key exclusion criteria (4 listed)
- Smokers
- Severe spinal injuries
- Inflammatory rheumatic disease
- Patients diagnosed with pulmonary Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| METsThe 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. | Other | MET group |
| Breathing exercise groupThree 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. | Other | Breathing exercise group |
Primary outcome
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).
4 secondary outcomes
Fibromyalgia impact questionnaire (FIQ)
Time frame: 4 and 8 weeks
6 Minute walk test (6MWT)
Time frame: 4 and 8 weeks
Pittsburgh sleep Quality Index (PSQI)
Time frame: 4 and 8 weeks
Measuring tape for the thoracoabdominal mobility indices
Time frame: 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 21285161Wolfe 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.
- Background: PubMed 27094397Forti 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.
- Background: PubMed 20657807Imamura 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.
- Background: PubMed 12218504Sim 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.
- Background: PubMed 22094204Sarzi-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.
- Background: PubMed 28779918Garrido 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.
- Background: PubMed 29653069Tomas-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing METs and Breathing exercise group in people with Fibromyalgia, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale for pain (NPRS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04674878, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.