FibromyalgiaNCT03408496
Myofascial Release of Physiological Chains and Muscle Stretching in Patients With Fibromyalgia
A study testing Myofascial release and Muscle stretching in people with Fibromyalgia, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Muscle stretching is a therapeutic technique commonly used by physiotherapists, but for the treatment of fibromyalgia it still has weak evidence to support its real effect. On the other hand, myofascial mobilization in the location of tender points, as it is the solution for the population, demonstrating effects on… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Myofascial release and Muscle stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jan 2018to 19 Mar 2019
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmation of the diagnosis by rheumatologists according to the diagnostic criteria established by the American College of Rheumatology of 1990 and 2010.
- Moderate to severe pain according to the Fibromyalgia Impact Questionnaire (≥ 4).
- Prescribed treatment (drug and/or psychological) stable in the last month before the selection for those who perform.
- Patients who live in the metropolitan area of Recife - Pernambuco, Brazil.
Who cannot join
- Nonpharmacologic therapies, except for psychological treatment if prescribed by the doctor at the same time of the study.
- Skin diseases.
- Patients classified as "very active" by the International Physical Activity Questionnaire.
- Women who use intrauterine devices (IUD).
- Pregnant women.
- Patients with other associated rheumatic disease or with modified posture due to congenital anatomic alteration.
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- Severe decompensated comorbidities (cancer, thyroid disease and diabetes).
- Infection, fever, hypotension, respiratory alterations limiting treatment.
- Cardiovascular event in the previous year.
- Presence of cardiac, renal or hepatic insufficiency.
- Arterial or peripheral venous insufficiency.
- Presence of a hypertrophic scar on the trunk.
- Obesity grade 3.
- Illiteracy.
- Severe psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myofascial Release of the Trunk Physiological Chains and Muscle Stretching on Pain, Quality of Life and Functional Capacity of Patients With Fibromyalgia: Randomized Controlled Clinical Trial
Muscle stretching is a therapeutic technique commonly used by physiotherapists, but for the treatment of fibromyalgia it still has weak evidence to support its real effect. On the other hand, myofascial mobilization in the location of tender points, as it is the solution for the population, demonstrating effects on the improvement of the symptoms, but not yet achieving the minimal clinically important change. In this context, myofascial release guided by physiological chains, so far not studied, is presented as an alternative to improve pain and quality of life in patients with fibromyalgia because it acts in a global way and, probably, more effective.
This study evaluates the effect of myofascial release of the trunk physiological chains and muscle stretching on pain, quality of life and functional capacity of patients with fibromyalgia when compared to the control group.
- Conditions
- Fibromyalgia
- Being tested
- Myofascial release, Muscle stretching, Control
- Keywords
- Myofascial release, Pain, Manual therapy, Muscle stretching, Quality of life
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial releaseOther
Manual therapy
Muscle stretchingOther
Muscle stretching
ControlOther
Medical appointment
| Study group | Role | What they receive |
|---|---|---|
| Myofascial release | Experimental | Eight consecutive weekly sessions lasting 40-45 minutes of myofascial release of the trunk physiological chains. The connective tissue of the flexion chain and the posterior static chain will be released. The myofascial release will be obtained through the mechanical effect produced by the friction of the therapist's hand with a surface of the patient's body, which is performed through "traces" executed with the fingers (thumb supported or middle finger on the indicator to achieve effect local) following as addressed chains. The release will be repeated until the feeling of local relaxation of the tissue. Receives: Other: Myofascial release |
| Muscle Stretching | Experimental | The muscle stretching protocol described by Bressan (2008) will be followed, which consists of 8 consecutive weekly sessions, lasting 40-45 minutes. In dorsal decubitus or sitting, the triceps surae, hamstring, gluteal, paravertebral, latissimocondyloideus, pectoral, trapezius and respiratory muscles will be stretched. The exercises will be performed in a series of five repetitions for 30 seconds. Receives: Other: Muscle stretching |
| Control | Active comparator | It will perform only the treatment prescribed by the responsable doctor, wich can be the use of drug and/or psychological treatment, and will be followed clinically by a rheumatologist during four medical appointments to monitor medication and follow in the analgesic's diary, according the standard procedure of attending the hospital where the patients will be recruited. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity level change
Self reported pain intensity measured by the Visual Analog Scale, wich ranges from 0 to 10, where 0 means absence of pain and 10 means the worst pain already felt
Measured: Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)
Quality of life score change
Evaluated by the Fibromyalgia Impact Questionnaire, wich evaluates aspects of functional capacity, work status, psychological disturbances and physical symptoms. The total score ranges from 0 to 100, where higher scores have a worst impact of fibromyalgia on quality of life and functional capacity.
Measured: Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)
Secondary outcomes (1)
Amount of analgesic ingested
Measured by the analgesic diary, wich is filled weekly
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start23 Jan 2018
- Primary completion16 Feb 2019
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be allocated in 3 groups. The myofascial release group, muscle stretching group and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Bretas Bittar Schulze, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408496
- Sponsor's protocol ID
- NSchulze
- Status last verified
- Sep 2018
- First submitted
- 7 Jan 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schulze NBB, Barreto TDNP, Alencar GG, da Silva TA, Duarte ALBP, Ranzolin A, Siqueira GR. The effect of myofascial release of the physiological chains on the pain and health status in patients with fibromyalgia, compared to passive muscle stretching and a control group: a randomized controlled clinical trial. Disabil Rehabil. 2024 Aug;46(16):3629-3642. doi: 10.1080/09638288.2023.2255130. Epub 2023 Sep 12.
PubMed 37698013
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofascial Release of the Trunk Physiological Chains and Muscle Stretching on Pain, Quality of Life and Functional Capacity of Patients With Fibromyalgia: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03408496
- Acronym / sponsor ID
- NSchulze
- Conditions
- Fibromyalgia
- Keywords
- Myofascial release, Pain, Manual therapy, Muscle stretching, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 24 Jan 2018 (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.
Muscle stretching is a therapeutic technique commonly used by physiotherapists, but for the treatment of fibromyalgia it still has weak evidence to support its real effect. On the other hand, myofascial mobilization in the location of tender points, as it is the solution for the population, demonstrating effects on the improvement of the symptoms, but not yet achieving the minimal clinically important change. In this context, myofascial release guided by physiological chains, so far not studied, is presented as an alternative to improve pain and quality of life in patients with fibromyalgia because it acts in a global way and, probably, more effective.
This study evaluates the effect of myofascial release of the trunk physiological chains and muscle stretching on pain, quality of life and functional capacity of patients with fibromyalgia when compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be allocated in 3 groups. The myofascial release group, muscle stretching group and control group.
| Arm | Type | Receives |
|---|---|---|
| Myofascial release | Experimental | Other: Myofascial releaseEight consecutive weekly sessions lasting 40-45 minutes of myofascial release of the trunk physiological chains. The connective tissue of the flexion chain and the posterior static chain will be released. The myofascial release will be obtained through the mechanical effect produced by the friction of the therapist's hand with a surface of the patient's body, which is performed through "traces" executed with the fingers (thumb supported or middle finger on the indicator to achieve effect local) following as addressed chains. The release will be repeated until the feeling of local relaxation of the tissue. |
| Muscle Stretching | Experimental | Other: Muscle stretchingThe muscle stretching protocol described by Bressan (2008) will be followed, which consists of 8 consecutive weekly sessions, lasting 40-45 minutes. In dorsal decubitus or sitting, the triceps surae, hamstring, gluteal, paravertebral, latissimocondyloideus, pectoral, trapezius and respiratory muscles will be stretched. The exercises will be performed in a series of five repetitions for 30 seconds. |
| Control | Active comparator | Other: ControlIt will perform only the treatment prescribed by the responsable doctor, wich can be the use of drug and/or psychological treatment, and will be followed clinically by a rheumatologist during four medical appointments to monitor medication and follow in the analgesic's diary, according the standard procedure of attending the hospital where the patients will be recruited. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Confirmation of the diagnosis by rheumatologists according to the diagnostic criteria established by the American College of Rheumatology of 1990 and 2010.
- Moderate to severe pain according to the Fibromyalgia Impact Questionnaire (≥ 4).
- Prescribed treatment (drug and/or psychological) stable in the last month before the selection for those who perform.
- Patients who live in the metropolitan area of Recife - Pernambuco, Brazil.
Key exclusion criteria (15 listed)
- Nonpharmacologic therapies, except for psychological treatment if prescribed by the doctor at the same time of the study.
- Skin diseases.
- Patients classified as "very active" by the International Physical Activity Questionnaire.
- Women who use intrauterine devices (IUD).
- Pregnant women.
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 |
|---|---|---|
| Myofascial releaseManual therapy | Other | Myofascial release |
| Muscle stretchingMuscle stretching | Other | Muscle Stretching |
| ControlMedical appointment | Other | Control |
Primary outcome
Pain intensity level change
Time frame: Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)
Self reported pain intensity measured by the Visual Analog Scale, wich ranges from 0 to 10, where 0 means absence of pain and 10 means the worst pain already felt
Quality of life score change
Time frame: Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)
Evaluated by the Fibromyalgia Impact Questionnaire, wich evaluates aspects of functional capacity, work status, psychological disturbances and physical symptoms. The total score ranges from 0 to 100, where higher scores have a worst impact of fibromyalgia on quality of life and functional capacity.
1 secondary outcome
Amount of analgesic ingested
Time frame: Up to 12 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 21 Mar 2019.
- Derived from this study: PubMed 37698013Schulze NBB, Barreto TDNP, Alencar GG, da Silva TA, Duarte ALBP, Ranzolin A, Siqueira GR. The effect of myofascial release of the physiological chains on the pain and health status in patients with fibromyalgia, compared to passive muscle stretching and a control group: a randomized controlled clinical trial. Disabil Rehabil. 2024 Aug;46(16):3629-3642. doi: 10.1080/09638288.2023.2255130. Epub 2023 Sep 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release and Muscle stretching in people with Fibromyalgia, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 4 inclusion and 15 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 21 Mar 2019. 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 Brazil. 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?
Pain intensity level change (time frame: Baseline, after 4 weeks since the beginning of the treatment, after 8 weeks since the beginning of the treatment, follow-up (after 12 weeks since the beginning of the treatment)). The study lists 2 primary outcomes in all. 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 NCT03408496, which also lists 1 linked publication.
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 21 Mar 2019.