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CompletedNCT04261296Updated Mar 1, 2023

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

An interventional study of dry needling and balneotherapy in Myofascial Pain Syndrome of Neck, sponsored by Ahi Evran University Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Ahi Evran University Education and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myofascial Pain Syndrome of Neck

Keywords

  • dry needling
  • spa
03

In context

Myofascial Pain Syndromes

1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.

This study's enrollment of 120 is above the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

Ahi Evran University Education and Research Hospital is the lead sponsor of 39 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Otherdry 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

  • Otherbalneotherapy

    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.

    Also known as: Spa

  • Otherdry needling +balneotherapy

    Both of these methods will be applied to patients in the third group.

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    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 outcomes

  1. Mood of the patients

    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.

  2. Pressure pain threshold

    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.

  3. Anxiety level of the patients

    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.

  4. Quality of life of the patients

    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.

  5. Kinesiophobia of the patients

    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.

  6. Disability level of the patients

    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.

  7. Global Assesment of the patients

    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.

07

Study locations

1 site
  • Ahi Evran University Education and Research Hospital
    Kırşehir, 40100, Turkey
08

References and documents

Publications

  • 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. PubMed 25042309 ↗

Individual participant data

Plan to share: No — I believe that the study results will be beneficial to the world of science.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04261296
Lead sponsor
Ahi Evran University Education and Research Hospital
Responsible party
Zeynep Karakuzu Güngör (Research Assistant, Ahi Evran University Education and Research Hospital) — Principal investigator
First posted
Feb 7, 2020
Start date
Feb 10, 2020
Primary completion
May 31, 2020
Completion
May 31, 2020
Last update
Mar 1, 2023

Study contacts

Zeynep Karakuzu Güngör, MD
principal investigator · Ahi Evran Unıversity Faculty of Medicine
Fatmanur Aybala Koçak, MD
study director · Ahi Evran Unıversity Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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