FibromyalgiaFibromyalgiaNCT03630757
Effects of Manual Therapy in Fibromyalgia Syndrome
A study testing Treatment in people with Fibromyalgia and Manual Therapies, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia syndrome (FMS) is among the most difficult diseases that restrict physical functions of patients due to persistent aches,sleep problems,psychological problems and decrease the quality of life. The aim of this study was to investigate the efficacy of manual therapy (MT) in the treatment of FMS patients. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Fibromyalgia, Manual Therapies
- What is being tested?
- Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2018to 7 Jul 2018
- 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 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 30 and 50
- No remission during the last 48 months
- Do not have regular physical activity
- Have had a daily activity limit of at least 1 day within 30 days
Who cannot join
- Cardiac, renal, hepatic insufficiency
- Severe physical disability
- Comorbid conditions (interstitial cystitis, inflammatory diseases)
- Chronic viral infection
- Fever
- Rheumatoid arthritis, herpes lupus
Show all 12Show fewer
- Multiple sclerosis, polio, epilepsy
- Hypertension and hypotension
- Respiratory deficiencies during treatment
- Skin lesions
- Psychiatric disorders
- Past surgical history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Manual Therapy on Pain, Spinal Mobility, Quality of Sleep and Emotional Status in Fibromyalgia Syndrome
Fibromyalgia syndrome (FMS) is among the most difficult diseases that restrict physical functions of patients due to persistent aches,sleep problems,psychological problems and decrease the quality of life. The aim of this study was to investigate the efficacy of manual therapy (MT) in the treatment of FMS patients.
Read the detailed description
Fibromyalgia syndrome (FMS) etiology is a chronic musculoskeletal system characterized by widespread pain and hyperalgesia in the body that is not yet known. At the same time, FMS patients are accompanied by functional emotional disorders including persistent muscle soreness, muscle spasms, mood disorders such as chronic fatigue, sleep disturbances, paresthesia, morning stiffness, depression, and cognitive disorders. The prevalence in the general population in the world between 2-4%, but reaching up to 7% between 50-80 years of age the prevalence of a study conducted in Turkey were found to be 3.6%. Frequently seen in women between the ages of 40-60, the quality of life of patients with FMS falls because of generalized pain in their bodies, accompanied by stress in 30-45% of patients.
According to Chaitow, there are 3 factors in the etiology of the dysfunctional model of FMS syndrome (biochemical, biomechanical, psychosocial) : (1) Negative emotional state may cause specific biochemical change, weakening of immune functions and change in muscle tone (2) Hyperventilation, blood oxygenation at the neural level, general anxiety and anxiety state, change in the structural components of the thoracic and cervical region (3) Chemical changes in blood flow may cause emotional and structural changes. The neuroendocrine hypothalamic pituitary that controls primer stress response may have abnormal release of corticotropin releasing hormone, adrenocorticotropic hormone, and cortisol, which are part of the adrenal axis. Hypothalamic corticotropin releasing hormone delays corticotropin release by insufficiency of interleukin-6 regulation in the neuronal function defect. Although the pathophysiology is not yet fully understood, it is thought to be related to environmental and genetic factors. The basal autonomic status of FMS patients is characterized by increased sympathetic system and reduced parasympathetic system. The most basic complaints of patients are generalized pain. For this reason, peripheral and central nociceptive pathways are dominant in the view of being active in FMS patients. Intramuscular connective tissue dysfunction, myofascial tissue inflammation and fibroblasts and release of pro-inflammatory cytokines cause chronic peripheral sensitization in these patients. Some authors have reported that trigger points have central sensitization-inducing effects, while others have indicated that such a situation is not the case because the patient with each trigger point is not FMS. In recent biopsy studies, it has been found that the level of collagen in the endomyositis of the FMS muscles is increased, the production of N-carboxymethylsine, which is the oxidative stress marker, is increased, and the tissue damage is increased and the CD-68 positive macrophage levels in the interstitial tissue are increased in the muscles. The disturbance in the peripheral and central mechanisms leads to impairment of the postural control and therefore the increase in the frequency of falls with equilibrium losses. In the treatment of these symptoms, it was reported that the application of myofascial relaxation techniques had positive effects on patients' quality of life, sleep patterns, joint stiffness, neck and back pain.
Myofascial release therapy Myofascial relaxation restores pain relief by restoring soft-touch dysfunctions. Behind the therapeutic effects of myofascial relaxation is the effect on the connective tissue, that is, the fascia, one of the structures that play a fundamental role in the musculoskeletal functions. According to this theory, the facial system makes a great contribution to the different functions spreading from head to foot and to the dynamic movements of the body through its ability to move. Hardened and shortened facial tissue (due to recurrent micro trauma or acute injury), loss of functional capacity and pain due to reduced ability to shear. Myofascial relaxation therapy can also restore the mobility and pain sensation in the joints by stretching, loosening to the myofascial tissue. Myofascial relaxation therapy is a combination of manual traction and long stretching maneuvers to open facial adhesions. There are two basic myofascial release techniques, direct and indirect. In the direct relaxation technique, the therapist uses a hand or device to apply slight pressures (for 90-120 seconds) directly on the restricted tissue. The direct technique also includes self myofascial relaxation techniques. In the indirect technique, the myofascial complex is extended for a longer time under less load. With myofascial relaxation, normalization of the morphological and inflammatory responses of fibroblasts injured in the context of recurrent strains is possible.
The aim of this study was to investigate the efficacy of myofascial relaxation and mobilization techniques in the treatment of FMS patients on pain, trigger point number, FMS effect score, spinal mobility, sleep quality, anxiety and depression.
- Conditions
- Fibromyalgia, Manual Therapies
- Being tested
- Treatment
- Keywords
- Fibromyalgia syndrome, Manual Therapies, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
In the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | While holding the patient's head with the therapist's hands,the cervical spinous processes with the fingertips palpitate to the occipital condyle towards the proximal.Then the fingers of both hands applied pressure to the axis in the space between the occipital condyle and the spinous process Receives: Other: Treatment |
| Group 2 | Placebo comparator | reaching to the feet while sitting together with warming and cooling periods Receives: Other: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The VAS pain score was measured to determine the pain level of the patients. The 0-10 cm chart was presented to the patient, with 0 no pain, 0 the most severe pain felt in life 10, 18 and was asked to mark the pain severity. Then the point marked with the millimetric ruler was measured and recorded.
Measured: Baseline, up to 3 weeks
Secondary outcomes (3)
Pittsburgh Quality of Sleep Questionnaire Index
This scale assesses sleep quality in the last month, the presence of sleep disturbance and the extent of this disorder. A total of 24 questions are covered, 19 of which are filled by the individual himself and 5 are filled by the individual's roommate. It is used only to evaluate the answers of the questions answered by the individual himself. Each item of the index takes a score between 0 (no annoyance) - 3 (serious annoyance). The sum of the scores of the seven subcomponents gives the total sleep quality score. The total score of the index is between 0 and 21, with scores below 5 indicating 'good' sleep quality and scores above 5 or 5 indicating 'poor' sleep quality.
Measured: Baseline, up to 3 weeks
Hospital of Anxiety and Depression Scale
Developed by Zigmond and Snaith in 1983, scale is used to assess patients in terms of anxiety and depression. The HAD scale contains a total of 14 questions, seven of which measure anxiety and the other seven (double count) of depression. As a result of the validity and reliability studies performed by Aydemir et al., The cut-off score for the HAD anxiety score (HAD-A) was 10/11 and for the HAD depression score (HAD-D) it was 7/8. Accordingly, areas above these scores are considered at risk. The risk of anxiety and depression in HAD is self-assessment scale used to measure the level and change of violence.
Measured: Baseline, up to 3 weeks
Fibromyalgia Impact Questionnaire
FIQ was used to assess functional status in a group of patients with fibromyalgia syndrome. This scale measures 10 different features including physical function, feeling good, not going to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the ability to feel good, low scores indicate healing or less affected than 19 diseases. The FIQ is filled by the patient and takes about 5 minutes to complete. The maximum possible score for each descendant is 10. So the total maximum score is 100. While an average FMS patient has 50 points, more severely affected FMS patients usually score over 70 and 70 points.
Measured: Baseline, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start2 Jan 2018
- Primary completion5 Apr 2018
- Study completion7 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Patients were randomly divided into 2 groups of 20 people. A randomized list is prepared in a computer environment by a statistician for randomization. In this list, the odd numbers for the control group and the MT group were given double numbers. The group identification is printed on sequentially numbered cards placed in sealed envelopes. After enrollment, the numbered envelope was opened by the patient and the blind investigator. For the study group, manual therapy (MT) was given and the home exercise program was given and for the control group only home exercise program was given. In the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk). The treatment program has been implemented by a physiotherapist who specializes in this area.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMRIS DUYMAZ, Istanbul Bilgi University
- Investigators
- TOMRIS DUYMAZ, Study director, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630757
- Sponsor's protocol ID
- 2018-40016-69
- Other IDs
- 2018
- Acronym
- Fibromyalgia
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Therapy on Pain, Spinal Mobility, Quality of Sleep and Emotional Status in Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT03630757
- Acronym / sponsor ID
- Fibromyalgia / 2018-40016-69
- Conditions
- Fibromyalgia, Manual Therapies
- Keywords
- Fibromyalgia syndrome, Manual Therapies, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 15 Aug 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.
Fibromyalgia syndrome (FMS) is among the most difficult diseases that restrict physical functions of patients due to persistent aches,sleep problems,psychological problems and decrease the quality of life. The aim of this study was to investigate the efficacy of manual therapy (MT) in the treatment of FMS patients.
Detailed description
Fibromyalgia syndrome (FMS) etiology is a chronic musculoskeletal system characterized by widespread pain and hyperalgesia in the body that is not yet known. At the same time, FMS patients are accompanied by functional emotional disorders including persistent muscle soreness, muscle spasms, mood disorders such as chronic fatigue, sleep disturbances, paresthesia, morning stiffness, depression, and cognitive disorders. The prevalence in the general population in the world between 2-4%, but reaching up to 7% between 50-80 years of age the prevalence of a study conducted in Turkey were found to be 3.6%. Frequently seen in women between the ages of 40-60, the quality of life of patients with FMS falls because of generalized pain in their bodies, accompanied by stress in 30-45% of patients.
According to Chaitow, there are 3 factors in the etiology of the dysfunctional model of FMS syndrome (biochemical, biomechanical, psychosocial) : (1) Negative emotional state may cause specific biochemical change, weakening of immune functions and change in muscle tone (2) Hyperventilation, blood oxygenation at the neural level, general anxiety and anxiety state, change in the structural components of the thoracic and cervical region (3) Chemical changes in blood flow may cause emotional and structural changes. The neuroendocrine hypothalamic pituitary that controls primer stress response may have abnormal release of corticotropin releasing hormone, adrenocorticotropic hormone, and cortisol, which are part of the adrenal axis. Hypothalamic corticotropin releasing hormone delays corticotropin release by insufficiency of interleukin-6 regulation in the neuronal function defect. Although the pathophysiology is not yet fully understood, it is thought to be related to environmental and genetic factors. The basal autonomic status of FMS patients is characterized by increased sympathetic system and reduced parasympathetic system. The most basic complaints of patients are generalized pain. For this reason, peripheral and central nociceptive pathways are dominant in the view of being active in FMS patients. Intramuscular connective tissue dysfunction, myofascial tissue inflammation and fibroblasts and release of pro-inflammatory cytokines cause chronic peripheral sensitization in these patients. Some authors have reported that trigger points have central sensitization-inducing effects, while others have indicated that such a situation is not the case because the patient with each trigger point is not FMS. In recent biopsy studies, it has been found that the level of collagen in the endomyositis of the FMS muscles is increased, the production of N-carboxymethylsine, which is the oxidative stress marker, is increased, and the tissue damage is increased and the CD-68 positive macrophage levels in the interstitial tissue are increased in the muscles. The disturbance in the peripheral and central mechanisms leads to impairment of the postural control and therefore the increase in the frequency of falls with equilibrium losses. In the treatment of these symptoms, it was reported that the application of myofascial relaxation techniques had positive effects on patients' quality of life, sleep patterns, joint stiffness, neck and back pain.
Myofascial release therapy Myofascial relaxation restores pain relief by restoring soft-touch dysfunctions. Behind the therapeutic effects of myofascial relaxation is the effect on the connective tissue, that is, the fascia, one of the structures that play a fundamental role in the musculoskeletal functions. According to this theory, the facial system makes a great contribution to the different functions spreading from head to foot and to the dynamic movements of the body through its ability to move. Hardened and shortened facial tissue (due to recurrent micro trauma or acute injury), loss of functional capacity and pain due to reduced ability to shear. Myofascial relaxation therapy can also restore the mobility and pain sensation in the joints by stretching, loosening to the myofascial tissue. Myofascial relaxation therapy is a combination of manual traction and long stretching maneuvers to open facial adhesions. There are two basic myofascial release techniques, direct and indirect. In the direct relaxation technique, the therapist uses a hand or device to apply slight pressures (for 90-120 seconds) directly on the restricted tissue. The direct technique also includes self myofascial relaxation techniques. In the indirect technique, the myofascial complex is extended for a longer time under less load. With myofascial relaxation, normalization of the morphological and inflammatory responses of fibroblasts injured in the context of recurrent strains is possible.
The aim of this study was to investigate the efficacy of myofascial relaxation and mobilization techniques in the treatment of FMS patients on pain, trigger point number, FMS effect score, spinal mobility, sleep quality, anxiety and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients were randomly divided into 2 groups of 20 people. A randomized list is prepared in a computer environment by a statistician for randomization. In this list, the odd numbers for the control group and the MT group were given double numbers. The group identification is printed on sequentially numbered cards placed in sealed envelopes. After enrollment, the numbered envelope was opened by the patient and the blind investigator. For the study group, manual therapy (MT) was given and the home exercise program was given and for the control group only home exercise program was given. In the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk). The treatment program has been implemented by a physiotherapist who specializes in this area.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: TreatmentWhile holding the patient's head with the therapist's hands,the cervical spinous processes with the fingertips palpitate to the occipital condyle towards the proximal.Then the fingers of both hands applied pressure to the axis in the space between the occipital condyle and the spinous process |
| Group 2 | Placebo comparator | Other: Treatmentreaching to the feet while sitting together with warming and cooling periods |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 30 and 50
- No remission during the last 48 months
- Do not have regular physical activity
- Have had a daily activity limit of at least 1 day within 30 days
Key exclusion criteria (12 listed)
- Cardiac, renal, hepatic insufficiency
- Severe physical disability
- Comorbid conditions (interstitial cystitis, inflammatory diseases)
- Chronic viral infection
- Fever
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 |
|---|---|---|
| TreatmentIn the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk). | Other | Group 2, Treatment |
Primary outcome
Visual Analog Scale
Time frame: Baseline, up to 3 weeks
The VAS pain score was measured to determine the pain level of the patients. The 0-10 cm chart was presented to the patient, with 0 no pain, 0 the most severe pain felt in life 10, 18 and was asked to mark the pain severity. Then the point marked with the millimetric ruler was measured and recorded.
3 secondary outcomes
Pittsburgh Quality of Sleep Questionnaire Index
Time frame: Baseline, up to 3 weeks
Hospital of Anxiety and Depression Scale
Time frame: Baseline, up to 3 weeks
Fibromyalgia Impact Questionnaire
Time frame: Baseline, up to 3 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 16 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
TOMRIS DUYMAZ study director
Istanbul Bilgi 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 Treatment in people with Fibromyalgia and Manual Therapies, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
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 12 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 16 Aug 2018. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Visual Analog Scale (time frame: Baseline, up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2018.