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Kinesio Taping and Inhibitory Treatment Techniques

Primary Purpose

Fibromyalgia

Status
Suspended
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Kinesio Taping and Inhibitory Treatment Techniques
Exercise and Electrical Stimulation Therapy
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Physical Therapy Modalities, Exercise, Electrical Stimulation Therapy, Bandages

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Adelaida María Castro-Sánchez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesio Taping and Inhibitory Treatment Techniques

Exercise and Electrical Stimulation Therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Pain Intensity
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)
Pittsburgh Quality of Sleep Questionnaire
Beck Inventory for Depression
Fibromyalgia Impact Questionnaire (FIQ)
Hospital Anxiety Depression Scale (HADS)
State-Trait Anxiety Inventory (STAI)
McGill Pain Questionnaire
Fatigue Impact Scale
Pain Pressure
Schöber Test
Widespread pain index
Symptom severity score
Measurement Finger-Floor

Full Information

First Posted
August 4, 2016
Last Updated
September 20, 2023
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT02859467
Brief Title
Kinesio Taping and Inhibitory Treatment Techniques
Official Title
Benefits of Kinesio Taping and Inhibitory Treatment Techniques in Patients With Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Physical Therapy Modalities, Exercise, Electrical Stimulation Therapy, Bandages

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesio Taping and Inhibitory Treatment Techniques
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise and Electrical Stimulation Therapy
Arm Type
Active Comparator
Arm Description
Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.
Intervention Type
Other
Intervention Name(s)
Kinesio Taping and Inhibitory Treatment Techniques
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise and Electrical Stimulation Therapy
Intervention Description
Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
Time Frame
Changes from Baseline, and 10 weeks
Secondary Outcome Measure Information:
Title
Quality of Life (SF-36)
Time Frame
Changes from Baseline, and 10 weeks
Title
Pittsburgh Quality of Sleep Questionnaire
Time Frame
Changes from Baseline, and 10 weeks
Title
Beck Inventory for Depression
Time Frame
Changes from Baseline, and 10 weeks
Title
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
Changes from Baseline, and 10 weeks
Title
Hospital Anxiety Depression Scale (HADS)
Time Frame
Changes from Baseline, and 10 weeks
Title
State-Trait Anxiety Inventory (STAI)
Time Frame
Changes from Baseline, and 10 weeks
Title
McGill Pain Questionnaire
Time Frame
Changes from Baseline, and 10 weeks
Title
Fatigue Impact Scale
Time Frame
Changes from Baseline, and 10 weeks
Title
Pain Pressure
Time Frame
Changes from Baseline, and 10 weeks
Title
Schöber Test
Time Frame
Changes from Baseline, and 10 weeks
Title
Widespread pain index
Time Frame
Changes from Baseline, and 10 weeks
Title
Symptom severity score
Time Frame
Changes from Baseline, and 10 weeks
Title
Measurement Finger-Floor
Time Frame
symptom severity scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Adelaida María Castro-Sánchez
City
Almería
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27377815
Citation
Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
Results Reference
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Fernandez-de-Las-Penas C, Arendt-Nielsen L. Myofascial pain and fibromyalgia: two different but overlapping disorders. Pain Manag. 2016 May;6(4):401-8. doi: 10.2217/pmt-2016-0013. Epub 2016 Jun 14.
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PubMed Identifier
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Citation
Saral I, Sindel D, Esmaeilzadeh S, Sertel-Berk HO, Oral A. The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial. Rheumatol Int. 2016 Oct;36(10):1379-89. doi: 10.1007/s00296-016-3473-8. Epub 2016 Apr 7.
Results Reference
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PubMed Identifier
27014012
Citation
Mendonca ME, Simis M, Grecco LC, Battistella LR, Baptista AF, Fregni F. Transcranial Direct Current Stimulation Combined with Aerobic Exercise to Optimize Analgesic Responses in Fibromyalgia: A Randomized Placebo-Controlled Clinical Trial. Front Hum Neurosci. 2016 Mar 10;10:68. doi: 10.3389/fnhum.2016.00068. eCollection 2016.
Results Reference
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PubMed Identifier
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Citation
Coppieters I, Cagnie B, Nijs J, van Oosterwijck J, Danneels L, De Pauw R, Meeus M. Effects of Stress and Relaxation on Central Pain Modulation in Chronic Whiplash and Fibromyalgia Patients Compared to Healthy Controls. Pain Physician. 2016 Mar;19(3):119-30.
Results Reference
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PubMed Identifier
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Citation
Yuan SL, Matsutani LA, Marques AP. Effectiveness of different styles of massage therapy in fibromyalgia: a systematic review and meta-analysis. Man Ther. 2015 Apr;20(2):257-64. doi: 10.1016/j.math.2014.09.003. Epub 2014 Oct 5.
Results Reference
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PubMed Identifier
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Citation
Liptan G, Mist S, Wright C, Arzt A, Jones KD. A pilot study of myofascial release therapy compared to Swedish massage in fibromyalgia. J Bodyw Mov Ther. 2013 Jul;17(3):365-70. doi: 10.1016/j.jbmt.2012.11.010. Epub 2013 Jan 3.
Results Reference
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PubMed Identifier
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Citation
Castro-Sanchez AM, Mataran-Penarrocha GA, Arroyo-Morales M, Saavedra-Hernandez M, Fernandez-Sola C, Moreno-Lorenzo C. Effects of myofascial release techniques on pain, physical function, and postural stability in patients with fibromyalgia: a randomized controlled trial. Clin Rehabil. 2011 Sep;25(9):800-13. doi: 10.1177/0269215511399476. Epub 2011 Jun 14.
Results Reference
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Citation
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Kinesio Taping and Inhibitory Treatment Techniques

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