NCT03545880

Brief Summary

Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Different therapeutic strategies targeting to decrease post-dry needling soreness need to be investigated. Since Kinesiotaping has been advocated for decreasing tone in the muscle tissues, it would be a potential intervention for this objective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

May 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

June 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

May 22, 2018

Last Update Submit

August 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in post-dry needling pain intensity before and after the intervention

    A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness and pain

    Baseline, immediately after, 24 hours after, 48 hours after and 72 hours after treatment

Secondary Outcomes (3)

  • Changes in cervical related-disability before and after the intervention

    Baseline and 72 hours after treatment

  • Changes in upper extremity related-disability before and after the intervention

    Baseline and 72 hours after treatment

  • Changes in pressure pain sensitivity

    Baseline, immediately after and 72 hours after treatment

Study Arms (2)

Kinesiotaping

EXPERIMENTAL

A Kinesiotaping will be provided over the upper trapezius muscle after the application of dry needling

Other: Kinesiotaping

Placebo

PLACEBO COMPARATOR

Individuals will not perform any action after the application of trigger point dry needling

Other: Placebo

Interventions

A Kinesiotaping will be provided over the upper trapezius muscle after the application of dry needling

Kinesiotaping
PlaceboOTHER

Individuals will not perform any action after the application of trigger point dry needling

Placebo

Eligibility Criteria

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

You may qualify if:

  • \- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature

You may not qualify if:

  • any contraindication to dry needling
  • whiplash injury;
  • previous cervical surgery;
  • cervical radiculopathy or myelopathy;
  • diagnosis of fibromyalgia syndrome;
  • having undergone any therapy intervention for the neck are in the previous 6 months;
  • fear to needles;
  • less than 18 or greater than 65 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 4, 2018

Study Start

June 6, 2018

Primary Completion

August 5, 2018

Study Completion

August 8, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations