Effects of Mobilization and Perceptive Rehabilitation on Patients With Fibromyalgia Syndrome

European University of Lefke

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: Perceptive Rehabilitation; Other: Mobilisation Techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT03705910

ETK00-2018-0206

Details and patient eligibility

About

The aim of our study is to determine and compare the effects of perceptive rehabilitation against other mobilization techniques on the treatment of fibromyalgia symptoms and disability. Participants in this study will be randomly assigned to three separate groups using a random allocation software program, the three groups receiving either perceptive rehabilitation (PR-group), mobilization techniques (Mob-group), or neither (the control group, C-group).

Full description

Fibromyalgia is considered to be a chronic, widespread musculoskeletal pain syndrome. Its most common symptoms are fatigue, anxiety, depression, and lack of concentration. These symptoms may lead to a decrease in the amount of physical activity that a sufferer can accomplish. Neck and back pain will also increase as the sedentary behaviour becomes the norm (Talotta et al., 2017). The best overall way of managing fibromyalgia is still under discussion, but according to the literature, symptoms are best managed by physiotherapy (García, Nicolás, and Hernández, 2016). Different programs can also be tailored to individual fibromyalgia sufferers with the aim of reducing pain (e.g. heat agents, electrotherapy, postural exercises, aerobic exercise, aqua-therapy and manual treatment).

However, according to Bronfort et al. (2010), there is insufficient evidence supporting the effectiveness of manual therapy as a treatment for fibromyalgia. According to Reis et al. (2014), a single thoracic mobilization session was able to improve short-term heart-rate variability, although the pain was not affected by the intervention.

Paolucci et al. (2016) used a new rehabilitation tool to treat pain with an increased reliance on proprioception. Practically, the tool consisted of cones made from a latex material which were placed under the patient's back during treatment sessions. These cones were intended to improve tactile response and proprioception, the so-called perceptual surface. According to this study, the tool was able to decrease pain and help to improve function. However, it is important to understand the tool's effect on long-term rehabilitation and compare it with other treatment methods. The aim of our study is to determine and compare the effects of perceptive rehabilitation and mobilization techniques on disability and fibromyalgia symptoms.

Our study will include 90 participants, with 30 participants in each group. The PR-group and the Mob-group will receive treatments twice per week for eight weeks, a total of 16 sessions; there will be no intervention in the C-group. Another physiotherapist will assess each group before and after all the sessions. The study will be single blind. Follow-up assessments will be three and six months after the last session.

Enrollment: 90 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

•Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria.

Exclusion criteria

• Having a diagnosis of chronic fatigue syndrome or myofascial pain syndrome,
• Using medicine other than simple analgesics,
• Vertebrobasilar insufficiency,
• Severe scoliosis or kyphoscoliosis,
• History of spine surgery,
• History of vertebral fracture,
• Rheumatic diseases,
• History of Benign or Malign tumour,
• Osteoporosis and conditions that cause osteoporosis,
• Presence of cardiovascular risk factors,
• Serious neurological problems,
• Psychiatric disorders,
• Chronic respiratory diseases,
• After upper motor neurone lesion,
• Attending regular physical activity or exercise class during the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Perceptive Rehabilitation (PR-group)

Active Comparator group

Description:

This treatment will include small latex cones with different resistance. In each session, over one hundred cones will be placed on a rigid wooden base using elastic strips. The patient will be asked to lie down supine on the material. Patients weigh will create pressure and reaction force to his/her body. Treatments will be 2 times a week till 8 weeks. The therapist will ask the patient firstly to breathe normally and feel the pressure. The patient will then perform breathing exercises and active exercises (including stretching, warming up, and cooling down) under supervision. During the session, the therapist will ask about the pressure of the cones and will correct the patient's posture.

Treatment:

Other: Perceptive Rehabilitation

Mobilisation Techniques (Mob-group)

Active Comparator group

Description:

A certified physiotherapist will perform mobilisation techniques. All participants in this group will receive treatment protocol according to the list on below. Treatments will be 2 times a week till 8 weeks. For this treatment, the participant should lie on a bed and change their position according to the technique (supine, position or side-lying). Also, the therapist will be changing her position according to the technique. All technique will be on the range of motion limit. For releasing techniques the therapist will apply three-dimensional pressures till 3-5 minutes, with the feeling of relaxing therapist will change the limit for the next point.

Treatment:

Other: Mobilisation Techniques

Control Group (C-group)

No Intervention group

Description:

This group will not receive any intervention during this period. C-group will attend assessments.