NCT04261296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 4, 2020

Last Update Submit

February 27, 2023

Conditions

Keywords

dry needlingspa

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Pain level of the patients will be determined by "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.

Secondary Outcomes (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +2 more secondary outcomes

Study Arms (3)

Dry needling

EXPERIMENTAL

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

balneotherapy

EXPERIMENTAL

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

Dry needling + balneotherapy

EXPERIMENTAL

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

Other: dry needling +balneotherapy

Interventions

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

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
balneotherapy

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

Dry needling + balneotherapy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University Education and Research Hospital

Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 25042309BACKGROUND

MeSH Terms

Interventions

Dry NeedlingBalneology

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Zeynep Karakuzu Güngör, MD

    Ahi Evran Unıversity Faculty of Medicine

    PRINCIPAL INVESTIGATOR
  • Fatmanur Aybala Koçak, MD

    Ahi Evran Unıversity Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 7, 2020

Study Start

February 10, 2020

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

I believe that the study results will be beneficial to the world of science.

Locations