INSTRUMENTED-MANUAL PHYSIOTHERAPY VERSUS NONINSTRUMENTED
- Conditions
- Neck Pain
- Interventions
- Procedure: Manual massageProcedure: Instrumented massage
- Registration Number
- NCT02953236
- Lead Sponsor
- University of Malaga
- Brief Summary
This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.
- Detailed Description
Background: There are several therapies currently used to treat myofascial trigger points, including conservative and invasive techniques. It has been shown that conservative techniques including therapeutic massage, stretching, transcutaneal electrical nerve stimulation, spray and stretch, cold laser treatment, and ultrasound are the most applied treatments for myofascial pain syndrome, but no single strategy has proved to be universally successful. Instrumented massage has shown clinical effectiveness on shoulder pain, low back pain, and only one study (case report) on myofascial trigger points. This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.
Methods/Design: The study includes 31 volunteers with myofascial trigger points on right trapezius muscle. Clinical and patient data were obtained from questionnaires, VAS, algometry, sono-myoelastography and myotonometry. Also, physiotherapist grip strength was measured. Subjects were randomly allocated into one of two groups: Instrumented massage or Manual massage. The intervention consisted in a single 20 minutes session of massage on the back and neck by the same therapist, depending of the group, massage was applied manually or instrumented.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
-
• To be of legal age.
- To understand correctly Spanish.
- To show their approval by signing the informed consent.
- Suffering from mechanical neck pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manual massage Manual massage - Instrumented massage Instrumented massage -
- Primary Outcome Measures
Name Time Method • Stiffness of the right upper trapezius myofascial trigger point measured by MyoptronPRO. 10 minutes Stiffness characteristics will be measured using a handheld MyotonPRO device (MyotonPRO, Myoton Ltd, Estonia). MyotonPRO has shown high levels of reliability in a session or between sessions both by the same operator (intra-rater) and between different operators (inter-rater), both in young subjects and elderly (Aird et al., 2012) (Mullix et al., 2012). Stiffness (N/m) will be calculated by software of MyotonPRO (Vain, 1994, 1995). Stiffness is the ability of tissue to restore it shape after removing of external force acting on the muscle.
• Pain as measured by VAS 10 minutes The Visual Analogue Scale (VAS) was designed to allow a subjective assessment of pain. A VAS is usually a horizontal line of 10 cm. with perpendicular lines at the ends, which are defined as the extreme limits of the painful experience. Previous studies have shown that the VAS has adequate psychometric properties, including test-retest reliability (r = 0.78) and convergent validity with other measures of pain such as the McGill Pain Questionnaire (r = 0.49 to 0.65) (Sriwatanakul K ., 1983).
• Stiffness (Hz) of the right upper trapezius myofascial trigger point measured by sono-myoelastography. 10 minutes Sono-myoelastography uses an external vibration source with a frequency less than 1000 Hz in conjunction with Doppler techniques to identify localized regions of increased tissue stiffness (Muro-Culebras, 2013). In this study vibrations will be produced in the right upper trapezius muscle using an external massage vibrator (Model NC70209, North Coast Medical, Gilroy, CA, USA) modified with a flat and elongated applicator (with an application area of 1 x 4 cm). This vibration source will be placed approximately 2-3 cm away from each of the points marked as ''positive'' in the clinical examination and induce vibrations of about 92 Hz. By use of the power Doppler technique, the sono-myoelastography images will be collected while applying vibrations.
- Secondary Outcome Measures
Name Time Method • Blood flow of the right upper trapezius myofascial trigger point measured by sono-myoelastography. 10 minutes Circulation will be studied using the Doppler technique, since it has been shown for other studies (Sikdar et al., 2009). The resistive index (RI) is determined in the ascending branch of the transverse cervical artery and in other arteries or arterioles that will be in the vicinity of points marked as ''positive'' in the clinical examination. The waveform of blood flow, based on Doppler flow, will be scored on a scale of 0-2 (Sikdar et al. 2009).
pain threshold pressure PPT 10 minutes • Grip strength as measured by a Dynamometer 10 minutes This instrument will be used to measure grip strength of both physiotherapist upper limbs. The dynamometer has proven to be the safest \[ICC = 0.98\] and most valid \[ICC = 0.99\] method to measure grip strength of the hand. (Bellace JV, 2000).
•PRO Neck Disability Index-Sp 10 minutes Neck Disability Index is the most widely used neck pain scale in the largest number of populations and has been validated most often against multiple measurements of function, pain, and clinical signs and symptoms. (Cleland et al., 2006). For this study we will use the Spanish version (NDI-Sp), since it has proven to be reliable (r = 0.98), valid, and sensitive to change. (Andrade et al., 2010).
•PRO Spine Functional Index SFI-Sp 10 minutes For this study we will use the Spanish version (SFI-Sp), since it has proven to be a valid and reliable measure of the spinal region result. This regional tool reflects the status and any change in the kinetic chain of the spine. This questionnaire has demonstrated high internal consistency (α = 0.85) and reliability (r = 0.96) (AI Cuesta-Vargas, 2014).
Trial Locations
- Locations (1)
Antonio Cuesta-Vargas
🇪🇸Malaga, Spain