Clinical trial NCT04814017: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Chronic Pain
Keywords: Physiotherapy
shock wave therapy
stretching exercises
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Intensity
timeFrame: Baseline
measure: Cervical Range of Motion
timeFrame: Baseline
measure: Disability
timeFrame: Baseline
measure: Pressure pain threshold (PPT)
timeFrame: Baseline
Secondary outcomes:
measure: Pain Intensity
timeFrame: 6 weeks
measure: Cervical Range of Motion
timeFrame: 6 weeks
measure: Disability
timeFrame: 6 weeks
measure: Pressure pain threshold (PPT)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Silivri Public Hospital
state: Silivri
Study officials:
affiliation: Saraykoy Vocational School
name: Aysenur OYMAK SOYSAL, Dr.
role: STUDY_CHAIR
affiliation: Denizli Private Health Hospital
name: Erol Ozen, Dr.
role: STUDY_CHAIR
References:
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.
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.
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.
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.