search
Back to results

Comparison of the Efficacy of Dry Needling and Balneotherapy in the Treatment of Myofascial Pain Syndrome

Primary Purpose

Myofascial Pain Syndrome of Neck

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
dry needling
balneotherapy
dry needling +balneotherapy
Sponsored by
Ahi Evran University Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome of Neck focused on measuring dry needling, spa

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female and male patients between the ages of 18-50 who have been diagnosed as "myofascial pain syndrome (MAS)" by clinical and examination
  2. Patients with cooperations who can correctly understand what is stated in the patient information form
  3. Patients who consent to participate in the study according to the informed voluntary consent form will be included in the study.

Exclusion Criteria:

  1. Presence of cervical disc hernia, radiculopathy or myelopathy
  2. Having tumoral, infectious, psychiatric, systemic disease and bleeding diathesis
  3. Stage 3-4 osteodegeneration
  4. Having a diagnosis of fibromyalgia syndrome according to the diagnostic criteria of 2016 American College of Rheumatology
  5. Presence of kyphoscoliosis
  6. Pregnancy
  7. Having had previous brain, neck or shoulder surgery
  8. Having received treatment for MAS in the last 6 months
  9. Symptom onset duration is less than 3 months
  10. Having analgesic use for any reason
  11. Failure to cooperate

Sites / Locations

  • Ahi Evran University Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dry needling

balneotherapy

Dry needling + balneotherapy

Arm Description

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.

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.

Arm3: dry needling + balneotherapy Both of these methods will be applied to patients in the third group.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Pain level of the patients will be determined by "Visual Analogue Scale".

Secondary Outcome Measures

Mood of the patients
Mood of the patients will be determined by using "Beck Depression Scale".
Pressure pain threshold
Pressure pain threshold will be measured in patients using algometer.
Anxiety level of the patients
Anxiety level of the patients will be determined by using "Beck Anxiety Scale"
Quality of life of the patients
Anxiety level of the patients will be determined by using "Short Form-36 Quality of Life. Scale"
Kinesiophobia of the patients
Anxiety level of the patients will be determined by using "Tampa Kinesiophobia Scale".
Disability level of the patients
Disability level of the patients will be determined by using "Neck Disability Questionnaire".
Global Assesment of the patients
Global Assesment of the patients will be determined by using "Global Assessment Scale".

Full Information

First Posted
February 4, 2020
Last Updated
February 27, 2023
Sponsor
Ahi Evran University Education and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04261296
Brief Title
Comparison of the Efficacy of Dry Needling and Balneotherapy in the Treatment of Myofascial Pain Syndrome
Official Title
Comparison of the Efficacy of Dry Needling and Balneotherapy in the Treatment of Myofascial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome of Neck
Keywords
dry needling, spa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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.
Arm Title
balneotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Dry needling + balneotherapy
Arm Type
Experimental
Arm Description
Arm3: dry needling + balneotherapy Both of these methods will be applied to patients in the third group.
Intervention Type
Other
Intervention Name(s)
dry needling
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
balneotherapy
Other Intervention Name(s)
Spa
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
dry needling +balneotherapy
Intervention Description
Both of these methods will be applied to patients in the third group.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Pain level of the patients will be determined by "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.
Secondary Outcome Measure Information:
Title
Mood of the patients
Description
Mood of the patients will be determined by using "Beck Depression 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 the mood of patients will be investigated.
Title
Pressure pain threshold
Description
Pressure pain threshold will be measured in patients using algometer.
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.
Title
Anxiety level of the patients
Description
Anxiety level of the patients will be determined by using "Beck Anxiety 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 the anxiety will be investigated.
Title
Quality of life of the patients
Description
Anxiety level of the patients will be determined by using "Short Form-36 Quality of Life. 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 quality of life will be investigated.
Title
Kinesiophobia of the patients
Description
Anxiety level of the patients will be determined by using "Tampa Kinesiophobia 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 kinesiophobia will be investigated.
Title
Disability level of the patients
Description
Disability level of the patients will be determined by using "Neck Disability Questionnaire".
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.
Title
Global Assesment of the patients
Description
Global Assesment of the patients will be determined by using "Global Assessment Scale".
Time Frame
The Global Assessment Scale will be used to evaluate patients at the 1st and 12th weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Karakuzu Güngör, MD
Organizational Affiliation
Ahi Evran Unıversity Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatmanur Aybala Koçak, MD
Organizational Affiliation
Ahi Evran Unıversity Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ahi Evran University Education and Research Hospital
City
Kırşehir
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I believe that the study results will be beneficial to the world of science.
Citations:
PubMed Identifier
25042309
Citation
Ong J, Claydon LS. The effect of dry needling for myofascial trigger points in the neck and shoulders: a systematic review and meta-analysis. J Bodyw Mov Ther. 2014 Jul;18(3):390-8. doi: 10.1016/j.jbmt.2013.11.009. Epub 2013 Nov 9.
Results Reference
background

Learn more about this trial

Comparison of the Efficacy of Dry Needling and Balneotherapy in the Treatment of Myofascial Pain Syndrome

We'll reach out to this number within 24 hrs