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Effects of Mobilization and Perceptive Rehabilitation on Patients With Fibromyalgia Syndrome

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ClinicalTrials.gov Identifier: NCT03705910
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Beraat Alptug, European University of Lefke

Tracking Information
First Submitted Date  ICMJE October 7, 2018
First Posted Date  ICMJE October 15, 2018
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE November 6, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
Revised-Fibromyalgia Impact Questionnaire (FIQR) [ 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 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03705910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2019)
  • Socio-demographic and clinical characteristics [ 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 ]
    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.
  • Body Mass Index (BMI) [ 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 ]
    Weight and height will be combined to report BMI in kg/m^2.
  • Postural assessment 1 [ 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 ]
    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.
  • Postural assessment 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 ]
    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.
  • Cervical flexibility tests [ 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 ]
    Cervical flexibility will be assessed in flexion, extension, rotation and lateral flexion according to Armiger & Martyn (2010).
  • Cervical joint position sense [ 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 ]
    The patient will have a small laser pointer mounted onto a lightweight headband, which they will wear. The patient will be seated 100 cm from the wall. Measurements will be noted on the graph paper. The starting point that is projected by the laser on the graph paper will be marked. First the patients will perform active neck movements with eyes open and than eyes closed. After movement, the patient will return their head as accurately as possible to the starting position. This will include 3 trials, which will include cervical flexion, lateral flexion. The final laser position is measured against the starting position in centimetres.
  • Pressure pain threshold and toleration [ 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 ]
    Pressure algometer will be used to assess pain threshold and toleration. Measurements will be taken from both side of the body (low cervical region, second rib, occiput, trapezius muscle and supraspinatus muscle).
  • Short form of McGill pain questionnaire (SF-MPQ) [ 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 ]
    Turkish version of Short form of McGill pain questionnaire (SF-MPQ) will be used in this study. The main section of this questionnaire includes 15 words that describe pain. Patients should mark these words according to their pain intensities on a rating scale (0:none, 1:mild, 2:moderate, 3:severe). Next section of the SF-MPQ is measurement of pain intensity according to the visual analogue scale (VAS). The last section is the evaluative total pain intensity. The total score of the main component is derived by adding the rank values given by the patient for each descriptor out of 45. Scores can range from 0 to 45. A higher score of the main component of the SF-MPQ reflects more serious pain.
  • Beck Depression Inventory (BDI) [ 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 ]
    Turkish version of Beck Depression Inventory (BDI) will be used in this study. This inventory has 21 self-report items about depressive symptoms. All items should be answered from 0 through 3. The higher score represents the more intensity of the symptom. Items should be answered according to the past 2 weeks. The total score on the BDI, which has a range of 0 to 63. Higher values represent greater severity of depression (0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression).
  • Fatigue Severity Scale (FSS) [ 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 ]
    Turkish version of Fatigue Severity Scale (FSS) will be used in this study. This scale has 9 items. Each item should be scored (strongly disagrees) 0 to 7 (strongly agrees). The minimum score=9 and maximum score possible=63. Higher score=greater fatigue severity. The average score for all 9 items constitutes the FSS score.
  • Pittsburgh Sleep Quality Index (PSQI) [ 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 ]
    Turkish version of Pittsburgh Sleep Quality Index (PSQI) will be used in this study. This is a self-reported index that has 19 items with Likert and open-ended response formats. This index should be answered according to the past month. Minimum Score "0" means "good sleep" and Maximum Score "21" means "disrupted sleep".
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • Socio-demographic and clinical characteristics [ 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 ]
    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.
  • Body Mass Index (BMI) [ 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 ]
    Weight and height will be combined to report BMI in kg/m^2.
  • Postural assessment 1 [ 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 ]
    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.
  • Postural assessment 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 ]
    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.
  • Cervical flexibility tests [ 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 ]
    Cervical flexibility will be assessed in flexion, extension, rotation and lateral flexion according to Armiger & Martyn (2010).
  • Cervical joint position sense [ 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 ]
    The patient will have a small laser pointer mounted onto a lightweight headband, which they will wear. The patient will be seated 100 cm from the wall. Measurements will be noted on the graph paper. The starting point that is projected by the laser on the graph paper will be marked. First the patients will perform active neck movements with eyes open and than eyes closed. After movement, the patient will return their head as accurately as possible to the starting position. This will include 3 trials, which will include cervical flexion, lateral flexion. The final laser position is measured against the starting position in centimetres.
  • Pressure pain threshold and toleration [ 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 ]
    Pressure algometer will be used to assess pain threshold and toleration. Measurements will be taken from both side of the body (low cervical region, second rib, occiput, trapezius muscle and supraspinatus muscle).
  • Short form of McGill pain questionnaire (SF-MPQ) [ 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 ]
    Turkish version of Short form of McGill pain questionnaire (SF-MPQ) will be used in this study. The main section of this questionnaire includes 15 words that describe pain. Patients should mark these words according to their pain intensities on a rating scale (0:none, 1:mild, 2:moderate, 3:severe). Next section of the SF-MPQ is measurement of pain intensity according to the visual analogue scale (VAS). The last section is the evaluative total pain intensity.
  • Beck Depression Inventory (BDI) [ 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 ]
    Turkish version of Beck Depression Inventory (BDI) will be used in this study. This inventory has 21 self-report items about depressive symptoms. All items should be answered from 0 through 3. The higher score represents the more intensity of the symptom. Items should be answered according to the past 2 weeks. The total score on the BDI, which has a range of 0 to 63. Higher values represent greater severity of depression (0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression).
  • Fatigue Severity Scale (FSS) [ 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 ]
    Turkish version of Fatigue Severity Scale (FSS) will be used in this study. This scale has 9 items. Each item should be scored (strongly disagrees) 0 to 7 (strongly agrees). The minimum score=9 and maximum score possible=63. Higher score=greater fatigue severity. The average score for all 9 items constitutes the FSS score.
  • Pittsburgh Sleep Quality Index (PSQI) [ 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 ]
    Turkish version of Pittsburgh Sleep Quality Index (PSQI) will be used in this study. This is a self-reported index that has 19 items with Likert and open-ended response formats. This index should be answered according to the past month. Minimum Score "0" means "good sleep" and Maximum Score "30" means "disrupted sleep".
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Mobilization and Perceptive Rehabilitation on Patients With Fibromyalgia Syndrome
Official Title  ICMJE Effects of Mobilization and Perceptive Rehabilitation on Disability and Symptoms of Patients With Fibromyalgia Syndrome- A Randomised Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome measures will be performed by an experienced physiotherapist who will be blinded to the group allocation.
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Active Comparator: Perceptive Rehabilitation (PR-group)

    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.

    Intervention: Other: Perceptive Rehabilitation
  • Active Comparator: Mobilisation Techniques (Mob-group)

    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.

    Intervention: Other: Mobilisation Techniques
  • No Intervention: Control Group (C-group)
    This group will not receive any intervention during this period. C-group will attend assessments.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Beraat Alptug, MSc +905338498379 balptug@eul.edu.tr
Contact: Emine H. Tüzün, Prof. Dr. +903926301370 ext 1370 handan.tuzun@gmail.com
Listed Location Countries  ICMJE Cyprus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03705910
Other Study ID Numbers  ICMJE ETK00-2018-0206
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beraat Alptug, European University of Lefke
Study Sponsor  ICMJE European University of Lefke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account European University of Lefke
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP