Kinesio Taping and Inhibitory Treatment Techniques

Sponsor

Universidad de Almeria (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02859467

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective: Compare the benefits of Kinesio Taping and Inhibitory Treatment Techniques for Cervical, Thoracic and Lumbar Spine in Patients with Fibromyalgia Syndrome (FMS).

Study Design: A single-blind randomized controlled trial was conducted on patients with FMS.

Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving kinesio taping and inhibitory treatment techniques, or to a control group for exercises and electrical stimulation therapy.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Other: Kinesio Taping and Inhibitory Treatment Techniques Other: Exercise and Electrical Stimulation Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Benefits of Kinesio Taping and Inhibitory Treatment Techniques in Patients With Fibromyalgia Syndrome

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kinesio Taping and Inhibitory Treatment Techniques During each session participants will receive the application kinesio taping in trapezius, infraspinatus and paravertebral muscles. Inhibitory Treatment Techniques: Release Technique of the trapezius muscle. Release Technique for scalene muscles. Technique suboccipital inhibition. Technique hands crossed for induction dorsal superficial fascia.	Other: Kinesio Taping and Inhibitory Treatment Techniques Kinesio Taping on trapezius, infraspinatus, and paravertebral muscles Inhibitory Treatment Techniques: Release Technique of the trapezius muscle. Release Technique for scalene muscles. Technique suboccipital inhibition. Technique hands crossed for induction dorsal superficial fascia.
Active Comparator: Exercise and Electrical Stimulation Therapy Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.	Other: Exercise and Electrical Stimulation Therapy Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.

Arm

Intervention/Treatment

Experimental: Kinesio Taping and Inhibitory Treatment Techniques

During each session participants will receive the application kinesio taping in trapezius, infraspinatus and paravertebral muscles. Inhibitory Treatment Techniques: Release Technique of the trapezius muscle. Release Technique for scalene muscles. Technique suboccipital inhibition. Technique hands crossed for induction dorsal superficial fascia.

Other: Kinesio Taping and Inhibitory Treatment Techniques

Kinesio Taping on trapezius, infraspinatus, and paravertebral muscles Inhibitory Treatment Techniques: Release Technique of the trapezius muscle. Release Technique for scalene muscles. Technique suboccipital inhibition. Technique hands crossed for induction dorsal superficial fascia.

Active Comparator: Exercise and Electrical Stimulation Therapy

Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.

Other: Exercise and Electrical Stimulation Therapy

Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.

Outcome Measures

Primary Outcome Measures

Pain Intensity [Changes from Baseline, and 10 weeks]
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.

Secondary Outcome Measures

Quality of Life (SF-36) [Changes from Baseline, and 10 weeks]
Pittsburgh Quality of Sleep Questionnaire [Changes from Baseline, and 10 weeks]
Beck Inventory for Depression [Changes from Baseline, and 10 weeks]
Fibromyalgia Impact Questionnaire (FIQ) [Changes from Baseline, and 10 weeks]
Hospital Anxiety Depression Scale (HADS) [Changes from Baseline, and 10 weeks]
State-Trait Anxiety Inventory (STAI) [Changes from Baseline, and 10 weeks]
McGill Pain Questionnaire [Changes from Baseline, and 10 weeks]
Fatigue Impact Scale [Changes from Baseline, and 10 weeks]
Pain Pressure [Changes from Baseline, and 10 weeks]
Schöber Test [Changes from Baseline, and 10 weeks]
Widespread pain index [Changes from Baseline, and 10 weeks]
Symptom severity score [Changes from Baseline, and 10 weeks]
Measurement Finger-Floor [symptom severity scale]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed Fibromyalgia Syndrome.
Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
Agreement to attend evening therapy sessions.
Non-practice of regular physical activity.

Exclusion Criteria:

A history of surgery.
The presence of comorbid conditions (e.g., morbid obesity, inflammatory diseases, irritable bowel syndrome and interstitial cystitis).
A history of whiplash injury.
Severe physical disability.
uncontrolled endocrine disorders (e.g., hyperthyroidism, diabetes); 6) illness (e.g., schizophrenia or substance abuse).
The use of medication other than as-needed analgesics (excluding long-term narcotics).
Malignancy.
Psychiatric disorders.
A score of ≥ 9 points in the Beck depression inventory.