Clinical trial NCT03705910: Effects of Mobilization and Perceptive Rehabilitation on Patients With Fibromyalgia Syndrome
Official title: Effects of Mobilization and Perceptive Rehabilitation on Disability and Symptoms of Patients With Fibromyalgia Syndrome- A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: proprioception
manual therapies
pain
health status
posture
sleep
fatigue
depression
Lead sponsor: European University of Lefke
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Revised-Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: 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:
measure: Socio-demographic and clinical characteristics
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Body Mass Index (BMI)
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Postural assessment 1
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Postural assessment 2
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Cervical flexibility tests
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Cervical joint position sense
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Pressure pain threshold and toleration
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Short form of McGill pain questionnaire (SF-MPQ)
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Beck Depression Inventory (BDI)
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Fatigue Severity Scale (FSS)
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: European University of Lefke
name: Beraat Alptug, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Emine H. Tüzün, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: European University of Lefke
name: Barıs Kececi, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Levent Eker, M. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010 Feb 25;18:3. doi: 10.1186/1746-1340-18-3.
citation: Angel Garcia D, Martinez Nicolas I, Saturno Hernandez PJ. "Clinical approach to fibromyalgia: Synthesis of Evidence-based recommendations, a systematic review". Reumatol Clin. 2016 Mar-Apr;12(2):65-71. doi: 10.1016/j.reuma.2015.06.001. Epub 2015 Oct 16. English, Spanish.
citation: Paolucci T, Baldari C, Di Franco M, Didona D, Reis V, Vetrano M, Iosa M, Trifoglio D, Zangrando F, Spadini E, Saraceni VM, Guidetti L. A New Rehabilitation Tool in Fibromyalgia: The Effects of Perceptive Rehabilitation on Pain and Function in a Clinical Randomized Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:7574589. doi: 10.1155/2016/7574589. Epub 2016 Jan 13.
citation: Reis MS, Durigan JL, Arena R, Rossi BR, Mendes RG, Borghi-Silva A. Effects of posteroanterior thoracic mobilization on heart rate variability and pain in women with fibromyalgia. Rehabil Res Pract. 2014;2014:898763. doi: 10.1155/2014/898763. Epub 2014 May 29.
citation: Talotta R, Bazzichi L, Di Franco M, Casale R, Batticciotto A, Gerardi MC, Sarzi-Puttini P. One year in review 2017: fibromyalgia. Clin Exp Rheumatol. 2017 May-Jun;35 Suppl 105(3):6-12. Epub 2017 Jun 28.