Clinical trial NCT03166995: Postural Exercises in Women With Fibromyalgia
Official title: Study of the Effect of a Postural Exercise Program in Women With Fibromyalgia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia,postural exercises
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 54
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In the current study, the investigators aimed to study:

* The proprioception status of patients with FMS.
* The effectiveness of a postural exercise program in women with fibromyalgia for 8 weeks (2 sessions per week), compared to a low impact aerobic exercise program on different parameters, such as proprioception, balance, muscle strength, flexibility and joint range.

Detailed description: Fibromyalgia syndrome (FMS) is a multisystemic disease, characterized by generalized chronic musculoskeletal pain. In addition, it is usually accompanied by fatigue, sleep disorders, morning stiffness, cognitive disorders, depression, anxiety and stress. Other common symptoms are back pain, headaches, irritable bowel, balance problems and deterioration of physical function.

It constitutes the second most common rheumatic 36 disorder after osteoarthritis, with a prevalence of 2.9% in Europe and a fivefold times greater incidence among women than men.

Patients with FMS have pain at specific pressure points known as "tender points", with increased sensitivity to painful stimuli (hyperalgesia) and a decreased pain threshold (allodynia), in the absence of abnormalities in the biological or imaging tests. These tender points constitute the basis of the most sensitive and specific criteria for the diagnosis of the disease, this is, the criteria of the American College of Rheumatology. Accordingly, women presenting at least 11 of 18 tender points are diagnosed with FMS.

The etiology of FMS remains unclear. However, the generalized hyperalgesia, widespread pain and spontaneous pain in FMS have been related to central changes, and many studies support a major role for central sensitization in the generation of the symptoms of FMS.

Since it is a chronic disease, the care of this type of patients represents a significant economic burden. They have great health care resource requirements in both direct medical care and indirect costs of staff absenteeism. For these reasons, it is considered a major problem with a great impact on the health system, and therefore more and more studies are being developed with the aim of better understanding the pathophysiology of this disease.

In general, the goal of the treatment should be to improve function. In this regard, some studies have demonstrated the efficacy of low-cost therapeutic measures, such as physical exercise programs, to improve FMS symptoms. Physical exercise has a direct effect on pain, joint and muscle stiffness, generalized sensitivity fatigue, cognitive function. Since there is no standard program, it is difficult to determine which exercise modality is most effective on FMS. Most studies focus on low-impact aerobic exercise performed between 60-70% of maximal heart rate two to three times a week.

On the other hand, it has been proposed that motor control problems, due mainly to an alteration of the central and peripheral system, are associated with muscle strength loss, motor or sensory deficits and suboptimal muscle coordination. The lack of balance may also be due to a disturbance in the perception or interpretation of auditory- vestibular signals. Therefore, postural stability training is recommended to stimulate the neuromuscular system and develop proprioceptive capacity aimed at improving motor control and postural balance among these patients. In this regard, it is important to note that FMS is associated with postural control and balance impairments, the latter being one of the 10 most debilitating symptoms, with a prevalence of 45%.

In the current study, the investigators aimed to study:

* The proprioception status of patients with FMS.
* The effectiveness of a postural exercise program in women with fibromyalgia for 8 weeks (2 sessions per week), compared to a low impact aerobic exercise program on different parameters, such as proprioception, balance, muscle strength, flexibility and joint range.

Eligibility criteria: Inclusion Criteria:

* Aged between 30 and 65 years.
* Meeting ACR 2010 criteria for FMS.

Exclusion Criteria:

* Medical contraindication for physical activity.
* Deafness or limited hearing.
* Vestibular disorders that compromise balance.
* Low vision or blindness.
* Psychotic disorder or cognitive impairment.
* Decompensation or changes in medication.
* Surgical interventions in the last six months.
* Rheumatic disease.

Primary outcomes:
measure: Proprioception
timeFrame: 8 weeks
Secondary outcomes:
measure: Balance
timeFrame: 8 weeks
measure: Handgrip strength
timeFrame: 8 weeks
measure: Joint range of motion
timeFrame: 8 weeks
measure: Pain
timeFrame: 8 weeks
measure: Leisure Time Physical Activity
timeFrame: 8 weeks
measure: Impact on quality of life
timeFrame: 8 weeks
measure: Anxiety and Depression
timeFrame: 8 weeks
measure: Fatigue
timeFrame: 8 weeks
measure: Sleep disorders
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy, University of Valencia
Study officials:
affiliation: Faculty of Physiotherapy. University of Valencia
name: Marta Inglés, PhD
role: PRINCIPAL_INVESTIGATOR
References: