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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02219386
Other study ID # 44/11Comision of investigation
Secondary ID
Status Completed
Phase N/A
First received August 8, 2014
Last updated August 30, 2014
Start date January 2011
Est. completion date January 2014

Study information

Verified date August 2014
Source University of Alcala
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the dimminution of pain of patients


Description:

EVALUATION:

A blind assesor does a complete evaluation of the patients to determine if they take part of the study. An assesment of pain (by visual analogue scale), Pain pressure theshold (kg/cm2 by algometry, Range of motion (CROM goniometer in degrees) and strength (digital dinamometry in Newtons) are performed. In this evaluation inclusion criteria is checked too.

INTERVENTION:

-TREATMENT GROUP(Deep dry needling group (DDN)):

An experienced physical therapist performed this treatment. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle with guided tube. ). In the case of upper trapezius active MTrPs, DDN was performed in the prone position. For medium and lower trapezius muscle MTrPs, DDN was performed in a side-lying position as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP.

After that, the stretch is performed

- Passive stretch of the trapezius muscle (both groups)

Another experienced physical therapist, after taking part of training-sesions to do the same stretch as in DDN group, performed the stretch.Participants in this group received the same stretch as patients in treatment group.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- over 18

- present myofascial trigger points in trapezius muscle

Exclusion Criteria:

- to be under anti-inflammatory, analgesic, anticoagulant, muscle relaxant or antidepressant medication at the start of the study or one week before it (Simons, 2004)

- to suffer from fibromyalgia syndrome, or to have any contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, fear of needles, wounds in the area of the puncture, metal allergy, cancer, systemic disease) (Baldry, 2005).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Other:
Group 1. Deep dry needling
Deep dry needling and stretch. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP. After four LTRs, the needle was withdrawn and the area was disinfected with alcohol again (Simons et al., 1999). Then, passive stretch was performed on the trapezius muscle.
group 2. Passive analitical stretch (performed in both groups)


Locations

Country Name City State
Spain UDAIF Alcalá de Henares Madrid

Sponsors (1)

Lead Sponsor Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Strenght scored by Digital dynamometer (Participants were followed for the duration of the intervention, an average of 6 weeks) pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention. Pretreatment, post treatment and follow-up. Yes
Other Cervical Range of Motion assesed with CROM goniometer (Participants were followed for the duration of the intervention, an average of 6 weeks) pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention. Participants were followed for the duration of the intervention, an average of 6 weeks) Pretreatment, post treatment and follow-up. Yes
Primary Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks) pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention. pretreatment, postreatment and follow-up(15 days) Yes
Secondary Pain Pressure Threshold (PPT. Participants were followed for the duration of the intervention, an average of 6 weeks) pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention. Pretreatment, post treatment and follow-up. Yes
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