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Clinical Trials/NCT03166995
NCT03166995
Completed
N/A

Study of the Effect of a Postural Exercise Program in Women With Fibromyalgia: a Randomized Clinical Trial

University of Valencia1 site in 1 country54 target enrollmentSeptember 4, 2017
ConditionsFibromyalgia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
University of Valencia
Enrollment
54
Locations
1
Primary Endpoint
Proprioception
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 4, 2017
End Date
December 29, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marta Inglés de la Torre

Principal investigator

University of Valencia

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.

Outcomes

Primary Outcomes

Proprioception

Time Frame: 8 weeks

Proprioception will be evaluated at baseline and at the end of the study possible differences between women with fibromyalgia and healthy women using an isokinetic device (BIODEX MULTI-JOINT SYSTEM - PRO). The following movements were analized: knee (flexion, extension), hip (flexion, extension, abduction, adduction), ankle (flexion, extension), shoulder (flexion, extension). Joint position sense for knee extension and shoulder flexion will be also performed.

Secondary Outcomes

  • Handgrip strength(8 weeks)
  • Impact on quality of life(8 weeks)
  • Pain(8 weeks)
  • Fatigue(8 weeks)
  • Joint range of motion(8 weeks)
  • Balance(8 weeks)
  • Leisure Time Physical Activity(8 weeks)
  • Anxiety and Depression(8 weeks)
  • Sleep disorders(8 weeks)

Study Sites (1)

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