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Effectiveness of ultrasound guided interfascial hydrodissection for myofascial pain syndrome of the upper trapezius: A single blind randomized controlled trial

PHRR200403-002587

Effectiveness of ultrasound guided interfascial hydrodissection for myofascial pain syndrome of the upper trapezius: A single blind randomized controlled trial

Myofascial pain syndrome (MPS) is a common condition that affects the society today which is usually the cause of neck, upper back and lower back pain. There are pharmacologic and non-pharmacologic treatments for MPS. However, both treatments have limited evidence in their effectiveness.

A newer needling technique called the interfascial block where anesthetic is injected in between the fascia of the trapezius and deeper muscles is being utilized. The objectives of this study is to determine short term and long term effectiveness of hydrodissection of the upper trapezius and stretching exercise compared to dry needling with self stretching exercise in the treatment of MPS using the Visual Analogue Scale (VAS). It will also determine any possible adverse effects during the study.

Study Design: This is a single blind randomized clinical trial including all patients who complains of upper back pain and diagnosed to have MPS.

Sample size calculation: computed using G*Power ver. 3.1.9.4 using a prior analysis for a repeated ANOVA (within-between interaction) at a postulated conservative moderate effect size (f= 0.25), power of 0.80 at α= 0.05. Based on the sample size analysis, the required sample is n=20 per group. Accounting for possible dropouts, a 20% inflation rate was adopted. Thus, this study will recruit n=44 total number of subjects (22 for each group).

 

Recruitment Process

Methods:   The participants will be divided into two groups.  Group 1 will have ultrasound guided interfascial block.   The intervention will be done by a registered musculoskeletal sonologist. Ultrasound guided interfascial block will be done using an ultrasound machine (Sonosite Edge) with a linear transducer (8 to 15 MHz) with a saline-anesthetic solution (1cc 2% lidocaine+5cc PNSS) injected between the fascia of the trapezius muscle and the fascia of the muscle directly under it.   Dry needling will be applied to participants in group 2 by a physiatrist who underwent training in dry needling.

Pain will be assessed using the visual analogue scale (VAS) score. It will be obtained prior to the procedure, immediately after the procedure, 10 minutes after the procedure, 1 week, 2 weeks, 4 weeks, 3 and 6 months follow up.

Statistical Analysis: For the VAS scores, a one-way repeated-measures ANOVA (within-between interaction) with follow-up Bonferroni correction (α= 0.05) will be conducted to determine the effect of the given intervention. Variables deemed non-normally distributed will be factored in the general linear model as a covariate. The effect size will be interpreted using the Cohens d. When the Mauchly’s test is significant (p< 0.05), the Greenhouse-Geisser correction will be applied. SPSS ver 23 will be used for statistical analysis.

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Biomedical products and engineering
Start Date Duration in Months Target Completion Date Actual Completion Date
2020-05-01 12 2021-05-01 0000-00-00

Ongoing

Institution Classification Region LTO #
University of Santo Tomas Hospital Private Non-profit NCR
Institution Classification Region LTO #
University of Santo Tomas Hospital, Department of Physical Medicine and Rehabilitation Private Business NCR
University of Santo Tomas, Department of Physical Medicine and Rehabilitation Private Business NCR
Institution Region
University of Santo Tomas Hospital, Department of Physical Medicine and Rehabilitation NCR
Name E-Mail Institution and Institution Address
Consuelo Suarez bebetsuarez61@gmail.com 17 Gen de Jesus St, San Juan, Metromanila
Name E-Mail Institution and Institution Address
Consuelo Suarez bebetsuarez61@gmail.com 17 Gen de Jesus St, San Juan, Metromanila
Name Expertise Affiliation
Charidy Marie Therese G. Suarez- Ramos, M.D. Rehabilitation Medicine Our Lady of Lourdes Hospital
Consuelo B. Gonzalez-Suarez, MD, PhD Rehabilitation Medicine University of Santo Tomas, Department of Physical Medicine and Rehabilitation
Jose Alfonso R. Llamas, M.D. Rehabilitation University of Santo Tomas Hospital, Department of Physical Medicine and Rehabilitation
Maria Katherine C. Gonzalez, M.D. Rehabilitation Medicine University of Santo Tomas Hospital, Department of Physical Medicine and Rehabilitation
Philippe Hubert C.S. Co, M.D. Rehabilitation Medicine University of Santo Tomas Hospital, Department of Physical Medicine and Rehabilitation

Myofascial pain syndrome of the upper trapezius

Pain  using the visual analogue scale (VAS) score. It will be obtained prior to the procedure, immediately after the procedure, 10 minutes after the procedure, 1 week, 2 weeks, 4 weeks, 3 and 6 months follow up.

 

Possible adverse events such as pain,  dizziness and infection on needle site injection

Recruiting

  • Philippines

Non-clinical Studies

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