Effects of Mobilization and Perceptive Rehabilitation on Patients With Fibromyalgia Syndrome

European University of Lefke90 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fibromyalgia

Interventions

Perceptive RehabilitationOTHER

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.

Mobilisation TechniquesOTHER

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eastern Mediterranean University

Famagusta, Cyprus

Outcomes

Primary Outcomes

Revised-Fibromyalgia Impact Questionnaire (FIQR)

Turkish version of FIQR will be use in this study. This questionnaire has 21 individual questions. All these questions should be answered according to the past 7 days. FIQR has divided to three sections; 'function, overall impact and symptoms'. The total FIQR score will be calculate with the sum of the three domain scores.

Time frame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

Secondary Outcomes

Socio-demographic and clinical characteristics

Date of birth, sex, marital status, profession, education status, medical histories, medications, time period of body pain, time of the diagnosis of FMS, symptoms, when pain increases, which activities increases pain and complaints will be noted.

Time frame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

Body Mass Index (BMI)

Weight and height will be combined to report BMI in kg/m\^2.

Time frame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

Postural assessment 1

New York Posture Rating Chart will be used to evaluate the posture. These evaluations will be on anterior, posterior and both lateral sides of the body. Therapist will give numerous rating for any deformities that can be seen. A score is allocated to each area according to the position: 5 points to the correct position; 3 points for a slight deviation, and 1 point for a pronounced deviation. Total score is between 18-90 points. Higher the points better the postural alignment.

Time frame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

Postural assessment 2

Posture Grid will be used to evaluate the posture. These evaluations will be on anterior, posterior and both lateral sides of the body. Therapist will note any deformities that can be seen.

Data from ClinicalTrials.gov

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