| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibromyalgia | Procedure: neural therapy Device: Physical Therapy | Not Applicable |
Fibromyalgia is a chronic disease characterized by widespread body pain, fatigue, sleep disturbance, and tenderness on palpation at trigger points in the musculoskeletal system.
Fibromyalgia prevalence is reported between 3% and 9%, and is three times more common in women than men. Although pharmacological and non-pharmacological approaches play a role in the treatment of the disease, the interest in non-pharmacological therapies has recently increased. In several studies, it has been shown that almost every fibromyalgia patient has applied at least one alternative and complementary medicine method such as Qigong, Tai Chi, yoga, mind body interventions, acupuncture, hydrotherapy, balneotherapy or phytotherapy.
Neural therapy is a regulation therapy that tries to correct this underlying autonomic dysfunction. In neural therapy; local painful areas, trigger points and symptomatic segments are included in the injection using local anesthetics and the underlying disruptive areas are investigated and treated. The aim of this study was to investigate the efficacy of neural therapy in fibromyalgia syndrome which is thought to have a neuroendocrine dysregulation disorder.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effectiveness of Neural Therapy in Patients With Fibromiyalgia |
| Actual Study Start Date : | January 20, 2019 |
| Actual Primary Completion Date : | April 20, 2019 |
| Actual Study Completion Date : | May 14, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Neural Therapy & home exercise program
Intracutaneous quaddle injections were performed using 1% lidocaine preparation as a local anesthetic for local application to painful points with palpation on the back and shoulders and for the segmental application, 2 cm lateral to the midline of the C1-T5 vertebrae and on spinous processes. Both the groups received education about fibromyalgia and home exercise program, which included stretching, strengthening, and aerobic exercises. |
Procedure: neural therapy
Intracutaneous quaddle injections were performed using 1% lidocaine preparation as a local anesthetic for local application to painful points with palpation on the back and shoulders and for the segmental application, 2 cm lateral to the midline of the C1-T5 vertebrae and on spinous processes.
|
|
Experimental: Physical Therapy & home exercise program
Physical therapy program was consist of transcutaneous electrical nerve stimulation- TENS (30-40 Hz, 20 minutes), hotpack (20 minutes) and continuous ultrasound (1mHz, 1.5w / cm2, 10 minutes) on painful points with palpation on the back and shoulders. Both the groups received education about fibromyalgia and home exercise program, which included stretching, strengthening, and aerobic exercises. |
Device: Physical Therapy
Physical therapy program was consist of transcutaneous electrical nerve stimulation- TENS (30-40 Hz, 20 minutes), hotpack (20 minutes) and continuous ultrasound (1mHz, 1.5w / cm2, 10 minutes) on painful points with palpation on the back and shoulders.
|
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | female sex |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Turkey | |
| Tuğba Atan | |
| Çorum, Turkey, 19100 | |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 1, 2019 | ||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||
| Last Update Posted Date | July 8, 2019 | ||||||
| Actual Study Start Date ICMJE | January 20, 2019 | ||||||
| Actual Primary Completion Date | April 20, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Visual analog scale for pain [ Time Frame: 4 weeks ] Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
|
||||||
| Original Primary Outcome Measures ICMJE |
Visual analog scale for pain (VAS- pain) [ Time Frame: 4 weeks ] Pain intensity was measured with visual analogue scale (0-10mm) which is used to measure musculoskeletal pain with very good reliability and validity.
|
||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Effectiveness of Neural Therapy in Patients With Fibromiyalgia | ||||||
| Official Title ICMJE | Effectiveness of Neural Therapy in Patients With Fibromiyalgia | ||||||
| Brief Summary | Neural therapy is a regulation therapy that tries to correct this underlying autonomic dysfunction. In neural therapy; local painful areas, trigger points and symptomatic segments are included in the injection using local anesthetics and the underlying disruptive areas are investigated and treated. The aim of this study was to investigate the efficacy of neural therapy in fibromyalgia syndrome which is thought to have a neuroendocrine dysregulation disorder. | ||||||
| Detailed Description |
Fibromyalgia is a chronic disease characterized by widespread body pain, fatigue, sleep disturbance, and tenderness on palpation at trigger points in the musculoskeletal system. Fibromyalgia prevalence is reported between 3% and 9%, and is three times more common in women than men. Although pharmacological and non-pharmacological approaches play a role in the treatment of the disease, the interest in non-pharmacological therapies has recently increased. In several studies, it has been shown that almost every fibromyalgia patient has applied at least one alternative and complementary medicine method such as Qigong, Tai Chi, yoga, mind body interventions, acupuncture, hydrotherapy, balneotherapy or phytotherapy. Neural therapy is a regulation therapy that tries to correct this underlying autonomic dysfunction. In neural therapy; local painful areas, trigger points and symptomatic segments are included in the injection using local anesthetics and the underlying disruptive areas are investigated and treated. The aim of this study was to investigate the efficacy of neural therapy in fibromyalgia syndrome which is thought to have a neuroendocrine dysregulation disorder. |
||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
| Condition ICMJE | Fibromyalgia | ||||||
| Intervention ICMJE |
|
||||||
| Study Arms ICMJE |
|
||||||
| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
60 | ||||||
| Original Actual Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | May 14, 2019 | ||||||
| Actual Primary Completion Date | April 20, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||
| Sex/Gender ICMJE |
|
||||||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Turkey | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04007172 | ||||||
| Other Study ID Numbers ICMJE | 2019-114 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Tuğba Atan, Hitit University | ||||||
| Study Sponsor ICMJE | Hitit University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Hitit University | ||||||
| Verification Date | July 2019 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||