FibromyalgiaNCT02859467
Kinesio Taping and Inhibitory Treatment Techniques
A study testing Kinesio Taping and Inhibitory Treatment Techniques and Exercise and Electrical Stimulation Therapy in people with Fibromyalgia, run by Universidad de Almeria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Kinesio Taping and Inhibitory Treatment Techniques and Exercise and Electrical Stimulation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2016to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- Malignancy.
- Psychiatric disorders.
- A score of ≥ 9 points in the Beck depression inventory.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Kinesio Taping and Inhibitory Treatment Techniques in Patients With Fibromyalgia Syndrome
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.
- Conditions
- Fibromyalgia
- Being tested
- Kinesio Taping and Inhibitory Treatment Techniques, Exercise and Electrical Stimulation Therapy
- Keywords
- Physical Therapy Modalities, Exercise, Electrical Stimulation Therapy, Bandages
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio Taping and Inhibitory Treatment TechniquesOther
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.
Exercise and Electrical Stimulation TherapyOther
Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise and Electrical Stimulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
Measured: Changes from Baseline, and 10 weeks
Secondary outcomes (13)
Quality of Life (SF-36)
Measured: Changes from Baseline, and 10 weeks
Pittsburgh Quality of Sleep Questionnaire
Measured: Changes from Baseline, and 10 weeks
Beck Inventory for Depression
Measured: Changes from Baseline, and 10 weeks
Fibromyalgia Impact Questionnaire (FIQ)
Measured: Changes from Baseline, and 10 weeks
Hospital Anxiety Depression Scale (HADS)
Measured: Changes from Baseline, and 10 weeks
State-Trait Anxiety Inventory (STAI)
Measured: Changes from Baseline, and 10 weeks
McGill Pain Questionnaire
Measured: Changes from Baseline, and 10 weeks
Fatigue Impact Scale
Measured: Changes from Baseline, and 10 weeks
Pain Pressure
Measured: Changes from Baseline, and 10 weeks
Schöber Test
Measured: Changes from Baseline, and 10 weeks
Widespread pain index
Measured: Changes from Baseline, and 10 weeks
Symptom severity score
Measured: Changes from Baseline, and 10 weeks
Measurement Finger-Floor
Measured: symptom severity scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2020
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859467
- Sponsor's protocol ID
- UAL-496
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2016
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27377815Fernandez-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.
PubMed 27296946Saral 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.
PubMed 27055444Mendonca 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.
PubMed 27014012Coppieters 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.
PubMed 27008285Yuan 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.
PubMed 25457196Liptan 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.
PubMed 23768283Castro-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.
PubMed 21673013Castro-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.
PubMed 21234327Ericsson 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.
PubMed 27473164
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Kinesio Taping and Inhibitory Treatment Techniques in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT02859467
- Acronym / sponsor ID
- UAL-496
- Conditions
- Fibromyalgia
- Keywords
- Physical Therapy Modalities, Exercise, Electrical Stimulation Therapy, Bandages
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping and Inhibitory Treatment Techniques | Experimental | Other: Kinesio Taping and Inhibitory Treatment TechniquesDuring 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. |
| Exercise and Electrical Stimulation Therapy | Active comparator | Other: Exercise and Electrical Stimulation TherapySession for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio Taping and Inhibitory Treatment TechniquesKinesio 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. | Other | Kinesio Taping and Inhibitory Treatment Techniques |
| Exercise and Electrical Stimulation TherapySession for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles. | Other | Exercise and Electrical Stimulation Therapy |
Primary outcome
Pain Intensity
Time frame: Changes from Baseline, and 10 weeks
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
13 secondary outcomes
Quality of Life (SF-36)
Time frame: Changes from Baseline, and 10 weeks
Pittsburgh Quality of Sleep Questionnaire
Time frame: Changes from Baseline, and 10 weeks
Beck Inventory for Depression
Time frame: Changes from Baseline, and 10 weeks
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Changes from Baseline, and 10 weeks
Hospital Anxiety Depression Scale (HADS)
Time frame: Changes from Baseline, and 10 weeks
State-Trait Anxiety Inventory (STAI)
Time frame: Changes from Baseline, and 10 weeks
McGill Pain Questionnaire
Time frame: Changes from Baseline, and 10 weeks
Fatigue Impact Scale
Time frame: Changes from Baseline, and 10 weeks
Pain Pressure
Time frame: Changes from Baseline, and 10 weeks
Schöber Test
Time frame: Changes from Baseline, and 10 weeks
Widespread pain index
Time frame: Changes from Baseline, and 10 weeks
Symptom severity score
Time frame: Changes from Baseline, and 10 weeks
Measurement Finger-Floor
Time frame: symptom severity scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 27377815Macfarlane 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.
- Background: PubMed 27296946Fernandez-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.
- Background: PubMed 27055444Saral 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.
- Background: PubMed 27014012Mendonca 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.
- Background: PubMed 27008285Coppieters 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.
- Background: PubMed 25457196Yuan 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.
- Background: PubMed 23768283Liptan 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.
- Background: PubMed 21673013Castro-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.
- Background: PubMed 21234327Castro-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.
- Background: PubMed 27473164Ericsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping and Inhibitory Treatment Techniques and Exercise and Electrical Stimulation Therapy in people with Fibromyalgia, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Changes from Baseline, and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02859467, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.