Effectiveness of Shock-wave Therapy in Patients With Myofascial Pain Syndrome
Primary Purpose
Myofascial Pain Syndrome, Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Radial Shock-Wave Therapy
Control
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Physiotherapy, shock wave therapy, stretching exercises
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Silivri Public Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Radial shock-wave group
Control
Arm Description
Group I (15 subjects) received radial shock-wave application one times a week for six weeks and home based stretching exercises.
Group II (15 subjects) received home based stretching exercises for six weeks.
Outcomes
Primary Outcome Measures
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).
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.
Disability
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
Pressure pain threshold (PPT)
Digital pressure algometer applied to patients active trigger points.
Secondary Outcome Measures
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).
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.
Disability
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
Pressure pain threshold (PPT)
Digital pressure algometer applied to patients active trigger points.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04814017
Brief Title
Effectiveness of Shock-wave Therapy in Patients With Myofascial Pain Syndrome
Official Title
Effectiveness of Radial Shock-wave Therapy Combined With Self-stretching Exercises in Patients With Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 28, 2013 (Actual)
Primary Completion Date
April 10, 2013 (Actual)
Study Completion Date
June 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
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
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.
Detailed Description
Thirty-four cervical MPS patients aged between 25-57 years (average age: 41,20±10,23 years) who diagnosed cervical MPS (myofascial pain syndrome), had cervical MPS for 6 months and who had at least one trigger point on their cervical, back and shoulder muscles were included to this study.
Thirty-four participant were included to the study. Taking into consideration including and excluding factors 34 participants divided into two groups: intervention shock-wave therapy group, control group. Because of several private reason (not attending treatment regularly and not participating in the final evaluations), 4 participant were excluded from study.
All assessments done by the same physiotherapist (FU) before the first session and one week after the last treatment session. Demographic data of participants recorded by using a form at the baseline of the study.
Patients in the intervention group (n=15) received 6 sessions radial shock wave treatment once a week during 6 weeks. During the treatment, the patients sat on chairs and supported their upper bodies with a pillow on the bed. Ultrasound gel was applied to the application area. Radial shock-wave therapy was applied to each trigger point in the preliminary evaluation. The muscles related trigger points were stretched position during the application. 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 scapulae muscles were treated.
Neck and upper back muscle static stretching exercises were teached to patients in the both groups 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Chronic Pain
Keywords
Physiotherapy, shock wave therapy, stretching exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radial shock-wave group
Arm Type
Experimental
Arm Description
Group I (15 subjects) received radial shock-wave application one times a week for six weeks and home based stretching exercises.
Arm Title
Control
Arm Type
Experimental
Arm Description
Group II (15 subjects) received home based stretching exercises for six weeks.
Intervention Type
Procedure
Intervention Name(s)
Radial Shock-Wave Therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity was measured using a Visual Analogue Scale (VAS) measuring 10 cm (0: I have no pain, 10: I have an intolerable pain).
Time Frame
Baseline
Title
Cervical Range of Motion
Description
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.
Time Frame
Baseline
Title
Disability
Description
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
Time Frame
Baseline
Title
Pressure pain threshold (PPT)
Description
Digital pressure algometer applied to patients active trigger points.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity was measured using a Visual Analogue Scale (VAS) measuring 10 cm (0: I have no pain, 10: I have an intolerable pain).
Time Frame
6 weeks
Title
Cervical Range of Motion
Description
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.
Time Frame
6 weeks
Title
Disability
Description
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
Time Frame
6 weeks
Title
Pressure pain threshold (PPT)
Description
Digital pressure algometer applied to patients active trigger points.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur OYMAK SOYSAL, Dr.
Organizational Affiliation
Saraykoy Vocational School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erol Ozen, Dr.
Organizational Affiliation
Denizli Private Health Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Silivri Public Hospital
City
Istanbul
State/Province
Silivri
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Because there is no web site to share my data
Citations:
PubMed Identifier
30171341
Citation
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.
Results Reference
result
PubMed Identifier
22139052
Citation
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.
Results Reference
result
PubMed Identifier
18469684
Citation
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.
Results Reference
result
PubMed Identifier
20354859
Citation
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.
Results Reference
result
Learn more about this trial
Effectiveness of Shock-wave Therapy in Patients With Myofascial Pain Syndrome
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