NCT04674878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

December 16, 2020

Last Update Submit

March 21, 2021

Conditions

Fibromyalgia

Keywords

Diaphragmatic breathingFibromyalgiaMuscle energy techniquesBreathing exercises

Outcome Measures

Primary Outcomes (1)

  • 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).

    8 weeks

Secondary Outcomes (4)

  • Fibromyalgia impact questionnaire (FIQ)

    4 and 8 weeks

  • 6 Minute walk test (6MWT)

    4 and 8 weeks

  • Pittsburgh sleep Quality Index (PSQI)

    4 and 8 weeks

  • Measuring tape for the thoracoabdominal mobility indices

    4 and 8 weeks

Study Arms (2)

MET group

EXPERIMENTAL

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

Other: METs

Breathing exercise group

ACTIVE COMPARATOR

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

Other: Breathing exercise group

Interventions

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.

MET group
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.

Breathing exercise group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American College of Rheumatology's criteria of fibromyalgia will be used

You may not qualify if:

  • Smokers
  • Severe spinal injuries
  • Inflammatory rheumatic disease
  • Patients diagnosed with pulmonary Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Rawalpindi, Federal, 44000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 21285161BACKGROUND

  • 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.

    PMID: 27094397BACKGROUND

  • 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.

    PMID: 20657807BACKGROUND

  • 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.

    PMID: 12218504BACKGROUND

  • 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.

    PMID: 22094204BACKGROUND

  • 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.

    PMID: 28779918BACKGROUND

  • 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.

    PMID: 29653069BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 19, 2020

Study Start

September 25, 2020

Primary Completion

January 15, 2021

Study Completion

January 20, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)