Myofascial Pain SyndromeNCT04814017
Effectiveness of Shock-wave Therapy in Patients With Myofascial Pain Syndrome
A study testing Radial Shock-Wave Therapy in people with Myofascial Pain Syndrome and Chronic Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome, Chronic Pain
- What is being tested?
- Radial Shock-Wave Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jan 2013to 30 Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Silivri Public Hospital
Istanbul, Silivri, 34000
About this study
Official title: Effectiveness of Radial Shock-wave Therapy Combined With Self-stretching Exercises in Patients With Myofascial Pain Syndrome
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.
Read the 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.
- Conditions
- Myofascial Pain Syndrome, Chronic Pain
- Being tested
- Radial Shock-Wave Therapy, Control
- Keywords
- Physiotherapy, shock wave therapy, stretching exercises
- Medical subject headings
- Myofascial Pain Syndromes, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Shock-Wave TherapyProcedure or surgery
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.
ControlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Radial Shock-Wave Therapy |
| Control | Experimental | Group II (15 subjects) received home based stretching exercises for six weeks. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline
Disability
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
Measured: Baseline
Pressure pain threshold (PPT)
Digital pressure algometer applied to patients active trigger points.
Measured: Baseline
Secondary 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).
Measured: 6 weeks
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.
Measured: 6 weeks
Disability
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
Measured: 6 weeks
Pressure pain threshold (PPT)
Digital pressure algometer applied to patients active trigger points.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start28 Jan 2013
- Primary completion10 Apr 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Uguz Selcuk, Pamukkale University
- Investigators
- Aysenur OYMAK SOYSAL, Dr., Study chair, Saraykoy Vocational SchoolErol Ozen, Dr., Study chair, Denizli Private Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814017
- Sponsor's protocol ID
- 24.01.2013/2
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because there is no web site to share my data
Publications
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.
PubMed 30171341Williams 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.
PubMed 22139052Aslan 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.
PubMed 18469684Ay 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.
PubMed 20354859
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Radial Shock-wave Therapy Combined With Self-stretching Exercises in Patients With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT04814017
- Acronym / sponsor ID
- 24.01.2013/2
- Conditions
- Myofascial Pain Syndrome, Chronic Pain
- Keywords
- Physiotherapy, shock wave therapy, stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 28 Jan 2013 (actual)
- Primary completion
- 10 Apr 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial shock-wave group | Experimental | Procedure: Radial Shock-Wave TherapyGroup I (15 subjects) received radial shock-wave application one times a week for six weeks and home based stretching exercises. |
| Control | Experimental | Procedure: ControlGroup II (15 subjects) received home based stretching exercises for six weeks. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial Shock-Wave TherapyRadial 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. | Procedure or surgery | Radial shock-wave group |
| ControlNeck 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. | Procedure or surgery | Control |
Primary outcome
Pain Intensity
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain.
Pressure pain threshold (PPT)
Time frame: Baseline
Digital pressure algometer applied to patients active trigger points.
4 secondary outcomes
Pain Intensity
Time frame: 6 weeks
Cervical Range of Motion
Time frame: 6 weeks
Disability
Time frame: 6 weeks
Pressure pain threshold (PPT)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Results publication: PubMed 30171341Kiraly 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 publication: PubMed 22139052Williams 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 publication: PubMed 18469684Aslan 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 publication: PubMed 20354859Ay 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.
- Individual participant dataSharing planned: No. Because there is no web site to share my data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysenur OYMAK SOYSAL, Dr. study chair
Saraykoy Vocational School
Erol Ozen, Dr. study chair
Denizli Private Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Shock-Wave Therapy in people with Myofascial Pain Syndrome and Chronic Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04814017, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.