Effectiveness of Shock-wave Therapy in Patients With Myofascial Pain Syndrome

NCT04814017 | Completed

• 1 other identifier: 24.01.2013/2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

30 patients with chronic cervical myofascial pain (4 males, 26 females) aged between 25 to 57 years (with average age 41,20±10,23 years) were included the study. Participants were divided into two groups as intervention group (n=15) and control group (n=15). Patients in intervention group received radial shock-wave application one times a week for six weeks and home based stretching exercises. Patients in control group (CG) received home based stretching exercises. Rest and activity pain (Visual Analog Scale), pressure pain threshold (PPT), cervical range of motion (CROM) and disability (Neck Disability Index) were assessed at baseline and after the treatment.

Conditions

Myofascial Pain Syndrome; Chronic Pain

Keywords

Physiotherapy; shock wave therapy; stretching exercises

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  Pain intensity was measured using a Visual Analogue Scale (VAS) measuring 10 cm (0: I have no pain, 10: I have an intolerable pain).

  Baseline

• Cervical Range of Motion

  Cervical range of motion (CROM) tool was used to assess cervical range of motion. Measurements were repeated three times in flexion, extension, rotation and lateral flexion directions.

  Baseline

• Disability

  Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.

  Baseline

• Pressure pain threshold (PPT)

  Digital pressure algometer applied to patients active trigger points.

  Baseline

Secondary Outcomes (4)

• Pain Intensity

  6 weeks

• Cervical Range of Motion

  6 weeks

• Disability

  6 weeks

• Pressure pain threshold (PPT)

  6 weeks

Study Arms (2)

Radial shock-wave group

EXPERIMENTAL

Group I (15 subjects) received radial shock-wave application one times a week for six weeks and home based stretching exercises.

Procedure: Radial Shock-Wave Therapy

Control

EXPERIMENTAL

Group II (15 subjects) received home based stretching exercises for six weeks.

Procedure: Control

Interventions

Radial Shock-Wave Therapy PROCEDURE

Radial shock-wave therapy was applied in 1.0-4.0 bar intensity, 10-15 hz frequency interval. 300-700 pulse for a trigger point, 1500-3000 pulse for a muscle. Intensity, frequency and pulse increased every session regularly beginning from minimal taking patients tolerance into consideration. Trigger points in the upper, middle and lower trapezius, supraspinatus, infraspinatus and levator scapula muscles were treated. Neck and upper back muscle static stretching exercises were teached to patients as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.

Radial shock-wave group

Control PROCEDURE

Neck and upper back muscle static stretching exercises were teached to patients as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.

Control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed cervical MPS
• Have cervical MPS for at least 6 months.
• Patients who has at least one trigger points on their cervical, back and shoulder muscles.

You may not qualify if:

• Fibromyalgia diagnosed patients in reference to 1990 ACR criteria.
• Patients who has characteristic cervical disc degeneration, radiculopathy, myelopathy.
• Patients who has cervical fracture, tumor, infection, malign, psychiatric and systemic illness.
• Patients who had an operation because of cervical problem.
• Patients who is treated with another treatment technique at the same time.
• Being pregnant

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Silivri Public Hospital

Istanbul, Silivri, 34000, Turkey (Türkiye)

Location

Related Publications (4)

• Kiraly M, Bender T, Hodosi K. Comparative study of shockwave therapy and low-level laser therapy effects in patients with myofascial pain syndrome of the trapezius. Rheumatol Int. 2018 Nov;38(11):2045-2052. doi: 10.1007/s00296-018-4134-x. Epub 2018 Aug 31.

  PMID: 30171341 RESULT

• Williams MA, Williamson E, Gates S, Cooke MW. Reproducibility of the cervical range of motion (CROM) device for individuals with sub-acute whiplash associated disorders. Eur Spine J. 2012 May;21(5):872-8. doi: 10.1007/s00586-011-2096-8. Epub 2011 Dec 3.

  PMID: 22139052 RESULT

• Aslan E, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagly N. The cultural adaptation, reliability and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2008 May 15;33(11):E362-5. doi: 10.1097/BRS.0b013e31817144e1.

  PMID: 18469684 RESULT

• Ay S, Dogan SK, Evcik D, Baser OC. Comparison the efficacy of phonophoresis and ultrasound therapy in myofascial pain syndrome. Rheumatol Int. 2011 Sep;31(9):1203-8. doi: 10.1007/s00296-010-1419-0. Epub 2010 Mar 31.

  PMID: 20354859 RESULT

MeSH Terms

Conditions

Myofascial Pain Syndromes; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aysenur OYMAK SOYSAL, Dr.

  Saraykoy Vocational School

  STUDY CHAIR

• Erol Ozen, Dr.

  Denizli Private Health Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 24, 2021
• Study Start: January 28, 2013
• Primary Completion: April 10, 2013
• Study Completion: June 30, 2013
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)