NCT03705910

Effects of Mobilization and Perceptive Rehabilitation on Patients With Fibromyalgia Syndrome

Effects of Mobilization and Perceptive Rehabilitation on Disability and Symptoms of Patients With Fibromyalgia Syndrome- A Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: European University of Lefke · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
OTHER	Perceptive Rehabilitation	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. At the end of each session, the therapist will photograph the patient's back with the aim of documenting the pressure and hyperaemic areas.
OTHER	Mobilisation Techniques	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.

Timeline

• Start date: 2018-11-06
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2018-10-15
• Last updated: 2023-06-22

Locations

1 site across 1 country: Cyprus