Shockwave Effectiveness in Myofascial Pain of the Upper Trapezius Muscle

NCT04121130 | Completed DMC

• 1 other identifier: REHA-2019-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Focused shockwaves are generated electrically, either within the applicator (electrohydraulic technique), or externally to it in the focal zone (electromagnetic or piezoelectric techniques), and then propagate to a designated focal point in order to treat it. Most research in shockwave therapy has focused on understanding the mechanism which results in the establishment of a mechano-sensitive feedback loop between the acoustic impulse and the stimulated cells, and involves specific transduction pathways and gene expression. Taking as valid the current physiopathological hypothesis of myofascial pain (MPS) and considering the mechanotransduction effect of ESWT in other diseases, it could be posited that ESWT in MPS may increase perfusion, promote angiogenesis and alter the pain signaling in ischaemic tissues caused by the influx of calcium. On the other hand, recent articles have demonstrated that free nerve endings degenerate after the application of ESWT, and that ESWT produces a transient dysfunction of nerve excitability at the neuromuscular junction, by bringing about the degeneration of AChR. Finally, following a pure mechanistic approach, shockwaves might be able to break-up the Actine-myosin links, as they are propagating perpendicularly to the sarcomere contractions. Study Hypothesis: To obtain pain relief and improvement in functional and quality of life scales, by performing 3 ESWT sessions, 1 per week (0,10 mJ/mm2; 2000 impulses; 5 Hz) in the most painful tender and/or trigger points of the upper trapezius muscle. Primary objective: To analyze the effectiveness of Focused Shockwave Treatment in myofascial pain of the upper trapezius muscle.

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (5)

• Algometric evaluation

  Pressure algometry \[PA\] is employed for quantification of tenderness in diagnosis of tender spots, trigger points, fibromyalgia and muscle spasm.

  12 weeks

• VAS (Visual Analogue Scale)

  The visual analogue scale (VAS) is considered to be one of the best methods available for the estimation of the intensity of pain.

  12 weeks

• Roles and Maudsley

  The RM scale is a subjective 4-point patient assessment of pain and limitations of activity. The RM score has been used extensively at centers throughout the world to assess outcome after SWT.

  12 weeks

• EuroQol five dimensions questionnaire

  The EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal.

  12 weeks

• EQ VAS

  The EQ-5D VAS is a standardized measure of global health status.

  12 weeks

Secondary Outcomes (1)

• Likert scale

  12 weeks

Study Arms (2)

Group A (F-ESWT Group)

ACTIVE COMPARATOR

3 F-ESWT sessions, 1 per week (0,10 mJ/mm2; 2000 impulses; 5 Hz) in the most painful tender and/or trigger points of the upper trapezius muscle.

Device: F-ESWT Group

Group B (sham F-ESWT):

PLACEBO COMPARATOR

3 sham F-ESWT sessions, 1 per week (0,01 mJ/mm2; 2000 SW; 5 Hz) in the most painful tender and/or trigger points of the upper trapezius muscle.

Device: sham F-ESWT

Interventions

F-ESWT Group DEVICE

3 F-ESWT sessions, 1 per week (0,10 mJ/mm2; 2000 impulses; 5 Hz) in the most painful tender and/or trigger points of the upper trapezius muscle.

Group A (F-ESWT Group)

sham F-ESWT DEVICE

3 sham F-ESWT sessions, 1 per week (0,01 mJ/mm2; 2000 SW; 5 Hz) in the most painful tender and/or trigger points of the upper trapezius muscle.

Group B (sham F-ESWT):

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• No range of motion restriction
• Informed consent signed
• Diagnosis of myofascial pain of the upper trapezius muscle.
• Myofascial pain of the upper trapezius muscle non-responsive to physioterapic treatments

You may not qualify if:

• Age \< 18 years
• Restricted range of motion
• Tumor in the area to be treated
• Wound in the area to be treated
• Coagulation disorders or anticoagulant therapy
• Local infection
• Pregnancy

Sponsors & Collaborators

• Fundación Garcia Cugat: lead

Study Sites (1)

Fundacion Garcia Cugat

Barcelona, 08023, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Montse García

  Fundación García Cugat

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: October 9, 2019
• Study Start: February 27, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 15, 2019
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)