FibromyalgiaNCT05622487
Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia
A study testing Neural Therapy and Kinesio taping in people with Fibromyalgia, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study; to investigate the effects of neural therapy and kinesio taping treatments on pain, functional status and quality of life in women with fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Neural Therapy and Kinesio taping
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jan 2022
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be diagnosed with fibromyalgia according to the ACR 2016 diagnostic criteria.
- Being a woman between the ages of 18 and 55.
- No change in the medical treatment he received for fibromyalgia syndrome during the study
- To be able to come to treatment 1 day a week for 6 weeks
Who cannot join
- Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
- Peripheral venous insufficiency, coagulopathies and anticoagulant drug use
- Loss of sensation, loss of position sense, unhealed fracture or open surgical wound
- Uncontrolled hypertension and uncontrolled diabetes
- Be in major depression
- Cognitive impairment that causes difficulty following simple commands
Show all 10Show fewer
- Pregnancy
- Be in menopause
- Allergy to local anesthetics and kinesio taping
- Open wound or infection at the application site
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatıh, 34034
Istanbul University
Istanbul, 3409
About this study
Official title: The Effects of Neural Therapy and Kinesio Taping on Pain, Functional Status, and Quality of Life in Fibromyalgia Patients: A Prospective Randomized Double-Blind Study
The aim of this study; to investigate the effects of neural therapy and kinesio taping treatments on pain, functional status and quality of life in women with fibromyalgia.
Read the detailed description
Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive impairment, and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. Neural therapy and kinesio taping are treatments for musculoskeletal diseases. In this prospective, randomized controlled, double-blind, interventional study, 64 patients aged 18-55 years who met the eligibility criteria will be included in the study. Eligible participants will be randomly assigned to one of two groups using computer generated random numbers. Segmental neural therapy and sham kinesio taping will be applied to the first group. In the second group, kinesio taping with inhibition technique will be applied to bilateral trapezius and erector spina muscles and sham neural therapy will be added. Treatments will be applied once a week for a total of 6 weeks. Both groups will be given a home exercise program consisting of stretching exercises and will be checked every week. During the follow-up period, patients will be asked not to make changes to their current medical treatment. Participants will be evaluated for pain by Visual Analogue Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Central Sensitisation Inventory (CSI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36), manual algometer measurements and number of tender points, as well as post-treatment and post-treatment 3 month control data.
- Conditions
- Fibromyalgia
- Being tested
- Neural Therapy, Kinesio taping
- Keywords
- Fibromyalgia, Neural Therapy, Kinesio Taping
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural TherapyOther
Neural therapy is a form of treatment that aims to act on the autonomic nervous system, by injecting local anesthetics into certain parts of the body.
Kinesio tapingOther
Kinesiotape is used for injury prevention, rehabilitation and performance enhancement. It has been shown to be clinically effective in increasing joint movements, increasing muscle activity, inducing muscle maximum torque earlier, and improving functional performance
| Study group | Role | What they receive |
|---|---|---|
| Neural Therapy | Active comparator | Segmental neural therapy will be administered with intradermal 0.5% lidocaine from cervical 1st to sacral 1st vertebra and upper trapezius region with quaddel injections.. Sham kinesio taping will be applied to the bilateral arms of the patients. Home exercise program; trapezius stretching, cervical, thoracic and lumbar paravertebral muscle stretching exercises will be required to be performed 10 times and every day. Receives: Other: Neural Therapy |
| Kinesio Taping | Active comparator | Kinesio taping will be applied with muscle inhibition technique by stretching from the origin to the insertion of the upper trapezius, cervical thoracic and lumbar paravertebral muscles. Sham neural therapy will be applied to the bilateral arms of the patients. Home exercise program; trapezius stretching, cervical, thoracic and lumbar paravertebral muscle stretching exercises will be required to be performed 10 times and every day. Receives: Other: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale pain (0-10 point).
Higher scores mean a worse outcome
Measured: up to 3 month
Fibromyalgia Impact Questionnaire (0-100 point)
The Fibromyalgia Impact Questionnaire was developed to assess the current functional status of women with FMS. Higher scores mean a worse outcome
Measured: up to 3 month
Pain measurement with manual algometer
18 tender points in 1990 ACR FMS criteria will be evaluated with a manual algometer. Higher scores mean a worse outcome
Measured: up to 3 month
Secondary outcomes (5)
Beck Depression Inventory (0-63 point)
Beck Depression Inventory (BDI) is a frequently used evaluation criterion as a diagnosis and follow-up parameter in evaluating the state of depression. Higher scores mean a worse outcome
Measured: up to 3 month
Beck Anxiety Inventory (0-63 point)
The scale aims to determine the frequency and severity of anxiety symptoms experienced by individuals. The highest score that can be obtained from the 21-item scale is 63. Higher scores mean a worse outcome
Measured: up to 3 month
Central Sensitisation Inventory (0-100 point)
Central sensitization scale; It is a scale used to detect central sensitization conditions such as fibromyalgia, migraine, myofascial pain, temporomandibular disorder. Higher scores mean a worse outcome
Measured: up to 3 month
Health Assessment Questionnaire (0-60 point)
The health assessment questionnaire shows the extent of the participant's functional ability, is sensitive to change, and is a good predictor of future cost and disability. Higher scores mean a worse outcome
Measured: up to 3 month
Short Form-36 (0-100 point)
Short Form-36 is one of the commonly used scales in which health concepts such as functional status and well-being are evaluated. This scale examines health in 8 dimensions: physical function, physical role limitations, emotional role limitations, social function, mental health, vitality (energy), pain and general perception of health. Higher scores mean a worse outcome
Measured: up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Mar 2021
- Primary completion1 Nov 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan GOK, Istanbul University
- Investigators
- Ayşegül Ketenci, Professor, Principal investigator, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622487
- Sponsor's protocol ID
- Istanbul Universty FMS
- Status last verified
- Nov 2022
- First submitted
- 6 Aug 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neural Therapy and Kinesio Taping on Pain, Functional Status, and Quality of Life in Fibromyalgia Patients: A Prospective Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT05622487
- Acronym / sponsor ID
- Istanbul Universty FMS
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Neural Therapy, Kinesio Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 18 Nov 2022 (actual)
- 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.
The aim of this study; to investigate the effects of neural therapy and kinesio taping treatments on pain, functional status and quality of life in women with fibromyalgia.
Detailed description
Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive impairment, and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. Neural therapy and kinesio taping are treatments for musculoskeletal diseases. In this prospective, randomized controlled, double-blind, interventional study, 64 patients aged 18-55 years who met the eligibility criteria will be included in the study. Eligible participants will be randomly assigned to one of two groups using computer generated random numbers. Segmental neural therapy and sham kinesio taping will be applied to the first group. In the second group, kinesio taping with inhibition technique will be applied to bilateral trapezius and erector spina muscles and sham neural therapy will be added. Treatments will be applied once a week for a total of 6 weeks. Both groups will be given a home exercise program consisting of stretching exercises and will be checked every week. During the follow-up period, patients will be asked not to make changes to their current medical treatment. Participants will be evaluated for pain by Visual Analogue Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Central Sensitisation Inventory (CSI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36), manual algometer measurements and number of tender points, as well as post-treatment and post-treatment 3 month control data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural Therapy | Active comparator | Other: Neural TherapySegmental neural therapy will be administered with intradermal 0.5% lidocaine from cervical 1st to sacral 1st vertebra and upper trapezius region with quaddel injections.. Sham kinesio taping will be applied to the bilateral arms of the patients. Home exercise program; trapezius stretching, cervical, thoracic and lumbar paravertebral muscle stretching exercises will be required to be performed 10 times and every day. |
| Kinesio Taping | Active comparator | Other: Kinesio tapingKinesio taping will be applied with muscle inhibition technique by stretching from the origin to the insertion of the upper trapezius, cervical thoracic and lumbar paravertebral muscles. Sham neural therapy will be applied to the bilateral arms of the patients. Home exercise program; trapezius stretching, cervical, thoracic and lumbar paravertebral muscle stretching exercises will be required to be performed 10 times and every day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- To be diagnosed with fibromyalgia according to the ACR 2016 diagnostic criteria.
- Being a woman between the ages of 18 and 55.
- No change in the medical treatment he received for fibromyalgia syndrome during the study
- To be able to come to treatment 1 day a week for 6 weeks
Key exclusion criteria (10 listed)
- Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
- Peripheral venous insufficiency, coagulopathies and anticoagulant drug use
- Loss of sensation, loss of position sense, unhealed fracture or open surgical wound
- Uncontrolled hypertension and uncontrolled diabetes
- Be in major depression
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 |
|---|---|---|
| Neural TherapyNeural therapy is a form of treatment that aims to act on the autonomic nervous system, by injecting local anesthetics into certain parts of the body. | Other | Neural Therapy |
| Kinesio tapingKinesiotape is used for injury prevention, rehabilitation and performance enhancement. It has been shown to be clinically effective in increasing joint movements, increasing muscle activity, inducing muscle maximum torque earlier, and improving functional performance | Other | Kinesio Taping |
Primary outcome
Visual Analogue Scale pain (0-10 point).
Time frame: up to 3 month
Higher scores mean a worse outcome
Fibromyalgia Impact Questionnaire (0-100 point)
Time frame: up to 3 month
The Fibromyalgia Impact Questionnaire was developed to assess the current functional status of women with FMS. Higher scores mean a worse outcome
Pain measurement with manual algometer
Time frame: up to 3 month
18 tender points in 1990 ACR FMS criteria will be evaluated with a manual algometer. Higher scores mean a worse outcome
5 secondary outcomes
Beck Depression Inventory (0-63 point)
Time frame: up to 3 month
Beck Anxiety Inventory (0-63 point)
Time frame: up to 3 month
Central Sensitisation Inventory (0-100 point)
Time frame: up to 3 month
Health Assessment Questionnaire (0-60 point)
Time frame: up to 3 month
Short Form-36 (0-100 point)
Time frame: up to 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ayşegül Ketenci, Professor principal investigator
Study Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Therapy and Kinesio taping in people with Fibromyalgia, run by Istanbul University at 2 sites in Turkey (Türkiye).
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 10 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: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale pain (0-10 point). (time frame: up to 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2022.