NCT03705910|Completed
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Sponsor study identifier
interventional
90
1 country
1
Study Start
November 6, 2018
Actual (reported)Primary Completion
May 30, 2023
Actual (reported)Study Completion
May 30, 2023
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2018
Actual (reported)October 15, 2018
Actual (reported)November 6, 2018
Actual (reported)May 30, 2023
Actual (reported)May 30, 2023
Actual (reported)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.
change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
Socio-demographic and clinical characteristics
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)
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
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
change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
Cervical flexibility tests
change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
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.
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.
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.
Eastern Mediterranean University
Famagusta, Cyprus
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.
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.
Beraat Alptug, MSc
European University of Lefke
Emine H. Tüzün, Prof. Dr.
Eastern Mediterranean University
Barıs Kececi, PT
European University of Lefke
Levent Eker, M. D.
Eastern Mediterranean University
90 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2018
First Posted
October 15, 2018
Study Start
November 6, 2018
Actual (reported)Use of Whole Body Vibration in Patients With Fibromyalgia
This group will not receive any intervention during this period. C-group will attend assessments.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
Alptug B, Tuzun EH, Kececi B, Eker L. Effects of perceptive rehabilitation and mobilization methods on symptoms and disability in patients with fibromyalgia: A preliminary randomized control trial. Ir J Med Sci. 2023 Dec;192(6):2937-2947. doi: 10.1007/s11845-023-03333-6. Epub 2023 Mar 10.
Primary Completion
May 30, 2023
Actual (reported)Study Completion
May 30, 2023
Actual (reported)Last Updated
June 22, 2023
Record last verified: 2023-06
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