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

Sponsor
Ahi Evran University Education and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04261296
Collaborator
(none)
120
1
3
3
39.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: dry needling
  • Other: balneotherapy
  • Other: dry needling +balneotherapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled studyrandomized controlled study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Efficacy of Dry Needling and Balneotherapy in the Treatment of Myofascial Pain Syndrome
Anticipated Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

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.

Other: dry needling
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.

Other: balneotherapy
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:
  • Spa
  • Experimental: Dry needling + balneotherapy

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analogue 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 pain will be investigated.]

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

    Secondary Outcome Measures

    1. Mood of the patients [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".

    2. Pressure pain threshold [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.]

      Pressure pain threshold will be measured in patients using algometer.

    3. Anxiety level of the patients [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.]

      Anxiety level of the patients will be determined by using "Beck Anxiety Scale"

    4. Quality of life of the patients [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"

    5. Kinesiophobia of the patients [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.]

      Anxiety level of the patients will be determined by using "Tampa Kinesiophobia Scale".

    6. Disability level of the patients [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.]

      Disability level of the patients will be determined by using "Neck Disability Questionnaire".

    7. Global Assesment of the patients [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".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahi Evran University Education and Research Hospital Kırşehir Turkey 40100

    Sponsors and Collaborators

    • Ahi Evran University Education and Research Hospital

    Investigators

    • Principal Investigator: Zeynep Karakuzu Güngör, MD, Ahi Evran Unıversity Faculty of Medicine
    • Study Director: Fatmanur Aybala Koçak, MD, Ahi Evran Unıversity Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zeynep Karakuzu Güngör, Research Assistant, Ahi Evran University Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04261296
    Other Study ID Numbers:
    • 2019-22/217
    First Posted:
    Feb 7, 2020
    Last Update Posted:
    Feb 7, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zeynep Karakuzu Güngör, Research Assistant, Ahi Evran University Education and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 7, 2020