NCT02859467

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4.3 years

First QC Date

August 4, 2016

Last Update Submit

September 20, 2023

Conditions

Keywords

Physical Therapy ModalitiesExerciseElectrical Stimulation TherapyBandages

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.

    Changes from Baseline, and 10 weeks

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Kinesio Taping and Inhibitory Treatment Techniques

EXPERIMENTAL

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

Exercise and Electrical Stimulation Therapy

ACTIVE COMPARATOR

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

Interventions

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.

Kinesio Taping and Inhibitory Treatment Techniques

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

Exercise and Electrical Stimulation Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adelaida María Castro-Sánchez

Almería, 04120, Spain

Location

Related Publications (10)

  • 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.

    PMID: 27377815BACKGROUND
  • 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.

    PMID: 27296946BACKGROUND
  • 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.

    PMID: 27055444BACKGROUND
  • 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.

    PMID: 27014012BACKGROUND
  • 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.

    PMID: 27008285BACKGROUND
  • 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.

    PMID: 25457196BACKGROUND
  • 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.

    PMID: 23768283BACKGROUND
  • 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.

    PMID: 21673013BACKGROUND
  • Castro-Sanchez AM, Mataran-Penarrocha GA, Granero-Molina J, Aguilera-Manrique G, Quesada-Rubio JM, Moreno-Lorenzo C. Benefits of massage-myofascial release therapy on pain, anxiety, quality of sleep, depression, and quality of life in patients with fibromyalgia. Evid Based Complement Alternat Med. 2011;2011:561753. doi: 10.1155/2011/561753. Epub 2010 Dec 28.

    PMID: 21234327BACKGROUND
  • Ericsson A, Palstam A, Larsson A, Lofgren M, Bileviciute-Ljungar I, Bjersing J, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves physical fatigue in women with fibromyalgia: a randomized controlled trial. Arthritis Res Ther. 2016 Jul 30;18:176. doi: 10.1186/s13075-016-1073-3.

    PMID: 27473164BACKGROUND

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

ExerciseElectric Stimulation Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2020

Study Completion

June 1, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations