Effects of Mobilization and Perceptive Rehabilitation on Patients With Fibromyalgia Syndrome

NCT03705910 | Completed

• 1 other identifier: ETK00-2018-0206
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Keywords

proprioception; manual therapies; pain; health status; posture; sleep; fatigue; depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

Study Arms (3)

Perceptive Rehabilitation (PR-group)

ACTIVE COMPARATOR

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.

Other: Perceptive Rehabilitation

Mobilisation Techniques (Mob-group)

ACTIVE COMPARATOR

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.

Other: Mobilisation Techniques

Control Group (C-group)

NO INTERVENTION

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

Interventions

Perceptive Rehabilitation OTHER

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.

Perceptive Rehabilitation (PR-group)

Mobilisation Techniques OTHER

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.

Mobilisation Techniques (Mob-group)

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University of Lefke: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, Cyprus

Location

Related Publications (6)

• 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.

  PMID: 20184717 BACKGROUND

• 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.

  PMID: 26481494 BACKGROUND

• 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.

  PMID: 26884794 BACKGROUND

• 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.

  PMID: 24991436 BACKGROUND

• 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.

  PMID: 28681712 BACKGROUND

• 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.

  PMID: 36897535 DERIVED

Related Links

• Armiger, P., \& Martyn, M. A. (2010). Stretching for functional flexibility: Wolters Kluwer Health/Lippincott, Williams, \& Wilkins.

MeSH Terms

Conditions

Fibromyalgia; Pain; Fatigue; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Beraat Alptug, MSc

  European University of Lefke

  PRINCIPAL INVESTIGATOR

• Emine H. Tüzün, Prof. Dr.

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

• Barıs Kececi, PT

  European University of Lefke

  PRINCIPAL INVESTIGATOR

• Levent Eker, M. D.

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be performed by an experienced physiotherapist who will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Physiotherapist

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 15, 2018
• Study Start: November 6, 2018
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CY (1)