Effects of Manual Therapy in Fibromyalgia Syndrome

NCT03630757 | Completed DMC

• 1 other identifier: 2018-40016-69
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Manual Therapies

Keywords

Fibromyalgia syndrome; Manual Therapies; Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  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.

  Baseline, up to 3 weeks

Secondary Outcomes (3)

• Pittsburgh Quality of Sleep Questionnaire Index

  Baseline, up to 3 weeks

• Hospital of Anxiety and Depression Scale

  Baseline, up to 3 weeks

• Fibromyalgia Impact Questionnaire

  Baseline, up to 3 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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

Group 2

PLACEBO COMPARATOR

reaching to the feet while sitting together with warming and cooling periods

Other: Treatment

Interventions

Treatment OTHER

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).

Group 2; Treatment

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Istanbul Bilgi University

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• TOMRIS DUYMAZ

  Istanbul Bilgi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 15, 2018
• Study Start: January 2, 2018
• Primary Completion: April 5, 2018
• Study Completion: July 7, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

TU (1)