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Effects of Manual Therapy in Fibromyalgia Syndrome (Fibromyalgia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03630757
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : August 16, 2018
Information provided by (Responsible Party):
TOMRIS DUYMAZ, Istanbul Bilgi University

Brief Summary:
Fibromyalgia syndrome (FMS) is among the most difficult diseases that restrict physical functions of patients due to persistent aches,sleep problems,psychological problems and decrease the quality of life. The aim of this study was to investigate the efficacy of manual therapy (MT) in the treatment of FMS patients.

Condition or disease Intervention/treatment Phase
Fibromyalgia Manual Therapies Other: Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients were randomly divided into 2 groups of 20 people. A randomized list is prepared in a computer environment by a statistician for randomization. In this list, the odd numbers for the control group and the MT group were given double numbers. The group identification is printed on sequentially numbered cards placed in sealed envelopes. After enrollment, the numbered envelope was opened by the patient and the blind investigator. For the study group, manual therapy (MT) was given and the home exercise program was given and for the control group only home exercise program was given. In the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk). The treatment program has been implemented by a physiotherapist who specializes in this area.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Manual Therapy on Pain, Spinal Mobility, Quality of Sleep and Emotional Status in Fibromyalgia Syndrome
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : April 5, 2018
Actual Study Completion Date : July 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Treatment
While holding the patient's head with the therapist's hands,the cervical spinous processes with the fingertips palpitate to the occipital condyle towards the proximal.Then the fingers of both hands applied pressure to the axis in the space between the occipital condyle and the spinous process
Other: Treatment
In the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk).

Placebo Comparator: Group 2
reaching to the feet while sitting together with warming and cooling periods
Other: Treatment
In the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk).

Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: Baseline, up to 3 weeks ]
    The VAS pain score was measured to determine the pain level of the patients. The 0-10 cm chart was presented to the patient, with 0 no pain, 0 the most severe pain felt in life 10, 18 and was asked to mark the pain severity. Then the point marked with the millimetric ruler was measured and recorded.

Secondary Outcome Measures :
  1. Pittsburgh Quality of Sleep Questionnaire Index [ Time Frame: Baseline, up to 3 weeks ]
    This scale assesses sleep quality in the last month, the presence of sleep disturbance and the extent of this disorder. A total of 24 questions are covered, 19 of which are filled by the individual himself and 5 are filled by the individual's roommate. It is used only to evaluate the answers of the questions answered by the individual himself. Each item of the index takes a score between 0 (no annoyance) - 3 (serious annoyance). The sum of the scores of the seven subcomponents gives the total sleep quality score. The total score of the index is between 0 and 21, with scores below 5 indicating 'good' sleep quality and scores above 5 or 5 indicating 'poor' sleep quality.

  2. Hospital of Anxiety and Depression Scale [ Time Frame: Baseline, up to 3 weeks ]
    Developed by Zigmond and Snaith in 1983, scale is used to assess patients in terms of anxiety and depression. The HAD scale contains a total of 14 questions, seven of which measure anxiety and the other seven (double count) of depression. As a result of the validity and reliability studies performed by Aydemir et al., The cut-off score for the HAD anxiety score (HAD-A) was 10/11 and for the HAD depression score (HAD-D) it was 7/8. Accordingly, areas above these scores are considered at risk. The risk of anxiety and depression in HAD is self-assessment scale used to measure the level and change of violence.

  3. Fibromyalgia Impact Questionnaire [ Time Frame: Baseline, up to 3 weeks ]
    FIQ was used to assess functional status in a group of patients with fibromyalgia syndrome. This scale measures 10 different features including physical function, feeling good, not going to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Except for the ability to feel good, low scores indicate healing or less affected than 19 diseases. The FIQ is filled by the patient and takes about 5 minutes to complete. The maximum possible score for each descendant is 10. So the total maximum score is 100. While an average FMS patient has 50 points, more severely affected FMS patients usually score over 70 and 70 points.

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Between the ages of 30 and 50
  • No remission during the last 48 months
  • Do not have regular physical activity
  • Have had a daily activity limit of at least 1 day within 30 days

Exclusion Criteria:

  • Cardiac, renal, hepatic insufficiency
  • Severe physical disability
  • Comorbid conditions (interstitial cystitis, inflammatory diseases)
  • Chronic viral infection
  • Fever
  • Rheumatoid arthritis, herpes lupus
  • Multiple sclerosis, polio, epilepsy
  • Hypertension and hypotension
  • Respiratory deficiencies during treatment
  • Skin lesions
  • Psychiatric disorders
  • Past surgical history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03630757

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Istanbul Bilgi University
Istanbul, Turkey, 34440
Sponsors and Collaborators
Istanbul Bilgi University
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Study Director: TOMRIS DUYMAZ Istanbul Bilgi University
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Responsible Party: TOMRIS DUYMAZ, Asst. Prof. Ph.D., Istanbul Bilgi University Identifier: NCT03630757    
Other Study ID Numbers: 2018-40016-69
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TOMRIS DUYMAZ, Istanbul Bilgi University:
Fibromyalgia syndrome
Manual Therapies
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases