- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04261296
Comparison of the Efficacy of Dry Needling and Balneotherapy in the Treatment of Myofascial Pain Syndrome
Myofascial pain syndrome (MAS) is a syndrome characterized by muscle spasm, tenderness, limited range of motion, stiffness, fatigue and sometimes autonomic dysfunctions accompanying pain and pain caused by trigger points in the tense bands formed in the muscles The disease is diagnosed clinically and there are many pharmacological and non-pharmacological approaches in treatment.
One of these treatments is dry needle therapy. Dry needling has been used for a long time in the treatment of myofascial pain syndrome.
Another treatment used in the treatment of myofascial pain syndrome is balneotherapy (spa treatment At Ahi Evran University Physical Therapy and Rehabilitation Center, balneotherapy is frequently used in the treatment of patients with myofascial pain syndrome.
The aim of this study is to compare the effectiveness of dry needling and balneotherapy, which has been used in the treatment of myofascial pain syndrome for many years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Myofascial pain syndrome (MAS) is a syndrome characterized by muscle spasm, tenderness, limited range of motion, stiffness, fatigue and sometimes autonomic dysfunctions accompanying pain and pain caused by trigger points in the tense bands formed in the muscles The disease is diagnosed clinically and there are many pharmacological and non-pharmacological approaches in treatment.
One of these treatments is dry needle therapy. Dry needling has been used for a long time in the treatment of myofascial pain syndrome.
Another treatment used in the treatment of myofascial pain syndrome is balneotherapy (spa treatment At Ahi Evran University Physical Therapy and Rehabilitation Center, balneotherapy is frequently used in the treatment of patients with myofascial pain syndrome.
The aim of this study is to compare the effectiveness of dry needling and balneotherapy, which has been used in the treatment of myofascial pain syndrome for many years.
120 volunteers are planned to be included in this study. Patients will be randomly divided into 3 groups. (randomization will be done as 1: 1: 1 with a closed envelope). The patients in the first group will be given "dry needle treatment" for the aching muscle. No medication is used in this treatment.In this treatment, depending on the thickness of the adipose tissue under the skin, 13 mm, 25 mm or 30 mm long; 0.20 mm thick acupuncture needle is used. Dry needling will be done with painful trigger point and it will be waited for about 20 minutes. This treatment will be repeated once a week for 3 weeks.
Patients in the second group will be given "spa treatment". A total of 15 sessions, 20 minutes a day, 5 days a week for 3 weeks, will be held in the spa, which operates within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Both of these methods will be applied to patients in the third group.
Evaluations will be repeated before treatment, 1st week after treatment and Week 12 (3rd Month). Patients' neck range of motion (by measuring with goniometer) will be evaluated and pressure pain threshold will be measured using algometer.
Patients' pain levels will be evaluated with Visual Analogue Scale, their moods with Beck Depression Scale, anxiety levels with Beck Anxiety Scale, fear of movement with Tampa Kinesiophobia Scale, neck functions with Neck Disability Questionnaire Questionnaire, and quality of life level with SF-36 Quality of Life Scale.
In addition, the Global Assessment Scale will be used to evaluate patients at the 1st and 12th weeks after treatment. This scale is scored as "-1 = deterioration, 0 = no change, 1 = slight improvement, 2 = significant improvement and 3 = near-normal improvement". Survey applications will take approximately 10 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zeynep Karakuzu Güngör, MD
- Phone Number: +905077750375
- Email: zeynepkarakuzu@hotmail.com.tr
Study Contact Backup
- Name: Fatmanur Aybala Koçak, MD
- Phone Number: +905052470739
- Email: faybalarem@gmail.com
Study Locations
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-
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Kırşehir, Turkey, 40100
- Ahi Evran University Education and Research Hospital
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Contact:
- Zeynep Karakuzu Güngör, MD
- Phone Number: +905077750375
- Email: zeynepkarakuzu@hotmail.com.tr
-
Contact:
- Fatmanur Aybala Kocak, MD
- Phone Number: +90505 2470739
- Email: faybalarem@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female and male patients between the ages of 18-50 who have been diagnosed as "myofascial pain syndrome (MAS)" by clinical and examination
- Patients with cooperations who can correctly understand what is stated in the patient information form
- Patients who consent to participate in the study according to the informed voluntary consent form will be included in the study.
Exclusion Criteria:
- Presence of cervical disc hernia, radiculopathy or myelopathy
- Having tumoral, infectious, psychiatric, systemic disease and bleeding diathesis
- Stage 3-4 osteodegeneration
- Having a diagnosis of fibromyalgia syndrome according to the diagnostic criteria of 2016 American College of Rheumatology
- Presence of kyphoscoliosis
- Pregnancy
- Having had previous brain, neck or shoulder surgery
- Having received treatment for MAS in the last 6 months
- Symptom onset duration is less than 3 months
- Having analgesic use for any reason
- Failure to cooperate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry needling
Arm 1: Dry needling group.
Dry needling will be done with painful trigger point and it will be waited for about 20 minutes.
This treatment will be repeated once a week for 3 weeks.No medication is used in this treatment.
|
In this treatment, depending on the thickness of the adipose tissue under the skin, 13 mm, 25 mm or 30 mm long; 0.20 mm thick acupuncture needle is used
|
Experimental: balneotherapy
Arm 2: Balneotherapy A total of 15 sessions, 20 minutes a day, 5 days a week for 3 weeks, will be held in the spa, which operates within the body of Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center.
|
This treatment method; An "alert-fit" performed in a certain time interval and in a cure style by using the methods and doses of hot mineral waters, gases and peloids (sludge) from natural underground, determined in detail, repeatedly in series as bath, drinking and inhalation treatments.
treatment can be defined as.
There are studies showing that the effect of balneotherapy is mechanical, thermal, chemical, anti-inflammatory and immunological.
Other Names:
|
Experimental: Dry needling + balneotherapy
Arm3: dry needling + balneotherapy Both of these methods will be applied to patients in the third group.
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Both of these methods will be applied to patients in the third group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain will be investigated.
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Pain level of the patients will be determined by "Visual Analogue Scale".
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Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain will be investigated.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood of the patients
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of the mood of patients will be investigated.
|
Mood of the patients will be determined by using "Beck Depression Scale".
|
Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of the mood of patients will be investigated.
|
Pressure pain threshold
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain pressure threshold will be investigated.
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Pressure pain threshold will be measured in patients using algometer.
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Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of pain pressure threshold will be investigated.
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Anxiety level of the patients
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of the anxiety will be investigated.
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Anxiety level of the patients will be determined by using "Beck Anxiety Scale"
|
Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of the anxiety will be investigated.
|
Quality of life of the patients
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the quality of life will be investigated.
|
Anxiety level of the patients will be determined by using "Short Form-36 Quality of Life.
Scale"
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Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the quality of life will be investigated.
|
Kinesiophobia of the patients
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of kinesiophobia will be investigated.
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Anxiety level of the patients will be determined by using "Tampa Kinesiophobia Scale".
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Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of kinesiophobia will be investigated.
|
Disability level of the patients
Time Frame: Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of disablity will be investigated.
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Disability level of the patients will be determined by using "Neck Disability Questionnaire".
|
Measurements will be made before treatment, at the 1st week after treatment and at the 3rd month after treatment. Then change of the level of disablity will be investigated.
|
Global Assesment of the patients
Time Frame: The Global Assessment Scale will be used to evaluate patients at the 1st and 12th weeks after treatment.
|
Global Assesment of the patients will be determined by using "Global Assessment Scale".
|
The Global Assessment Scale will be used to evaluate patients at the 1st and 12th weeks after treatment.
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-22/217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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