NCT02219386

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
Last Updated

September 3, 2014

Status Verified

August 1, 2014

Enrollment Period

2.9 years

First QC Date

August 8, 2014

Last Update Submit

August 30, 2014

Conditions

Keywords

Myofascial pain syndromes,physiotherapy,muscle stretching exercises,neck pain,dry needling

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Pain Pressure Threshold (PPT. Participants were followed for the duration of the intervention, an average of 6 weeks)

    Pretreatment, post treatment and follow-up.

Other Outcomes (2)

  • Strenght scored by Digital dynamometer (Participants were followed for the duration of the intervention, an average of 6 weeks)

    Pretreatment, post treatment and follow-up.

  • Cervical Range of Motion assesed with CROM goniometer (Participants were followed for the duration of the intervention, an average of 6 weeks)

    Pretreatment, post treatment and follow-up.

Study Arms (2)

Deep dry needling

ACTIVE COMPARATOR

The group of DDN receive this treatment and stretch

Other: Group 1. Deep dry needling

muscle stretch

OTHER

The stretch applied was as described by Simons et al. (Simons et al., 1999). During the stretch the physiotherapist took up the slack, avoiding pain elicitation, maintaining the tension for four seconds and releasing the tension for eight seconds; this cycle was repeated three times

Other: Group 1. Deep dry needlingOther: group 2. Passive analitical stretch (performed in both groups)

Interventions

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.

Deep dry needlingmuscle stretch
Also known as: only the same stretch as performed in deep dry needling group.
muscle stretch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18
  • present myofascial trigger points in trapezius muscle

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UDAIF

Alcalá de Henares, Madrid, 28820, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Ester Cerezo-Téllez, PT

    Alcalá University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist.Master.

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 18, 2014

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

September 3, 2014

Record last verified: 2014-08

Locations