Clinical Outcomes After Dry Needling on Cervical Muscles, Quality of Life, Fatigue, Quality of Sleep, Anxiety and Depression in Patients With Fibromyalgia Syndrome.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Universidad de Almeria
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Active and Latent Myofascial Trigger Points (Number of trigger Points)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Objectives: The purpose of the current randomized clinical trial is to compare the effectiveness of dry needling versus myofascial release therapy on myofascial trigger points (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and depression in patients with fibromyalgia syndrome (FMS).
Detailed Description
Design: A single-blind randomized controlled trial will be conducted on patients with FMS. Methods: Sixty-four subjects with FMS will be randomly assigned to an experimental group receiving dry needling therapy, or to a control group for myofascial release therapy in the trigger points active or latent in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus. Myofascial trigger points, quality of life, impact of fibromyalgia symptoms, quality of sleep, intensity of pain, anxiety levels, state of depression, impact of fatigue will be recorded at baseline and after four weeks of treatment.
Investigators
Adelaida María Castro-Sánchez
PhD, Full Professor
Universidad de Almeria
Eligibility Criteria
Inclusion Criteria
- •Fibromyalgia syndrome diagnosis.
- •Aged from 18 to 60 years.
- •No regular physical activity.
- •Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
- •Agreement to attend evening therapy sessions
Exclusion Criteria
- •Receipt of any no pharmacologic therapies.
- •Presence of cardiac, renal or hepatic insufficiency.
- •Severe physical disability.
- •Comorbid condition (eg, inflammatory disease).
- •Infection fever.
- •Hypotension.
- •Skin alterations.
- •Psychiatric illness.
- •Previous history of surgery.
Outcomes
Primary Outcomes
Active and Latent Myofascial Trigger Points (Number of trigger Points)
Time Frame: Change from baseline myofascial trigger points at four weeks
Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.
Secondary Outcomes
- Quality of Life (SF-36 quality of life questionnaire)(Change from baseline quality of life at four weeks)
- Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)(Change from baseline impact of fibromyalgia symptoms at four weeks)
- Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)(Change from baseline quality of life at four weeks)
- Pain (Visual Analog Scale)(Change from baseline pain intensity at four weeks)
- Anxiety levels (State-Trait Anxiety Inventory )(Change from baseline anxiety levels at four weeks)
- State of depression (Beck Depression Inventory)(Change from state of depression at four weeks)
- Impact of fatigue (Fatigue Impact Scale )(Change from impact of fatigue at four weeks)