NCT02927977

Brief Summary

The purpose of this randomized clinical trial is to verify the effectiveness of the addition of the dry needling in individuals with non-specific neck pain who receive a multimodal physical therapy rehabilitation program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

October 5, 2016

Last Update Submit

November 10, 2018

Conditions

Keywords

dry needlingexercisemanual therapy

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    measured by 11-point numeric rating scale

    4 weeks after randomisation

  • disability

    measured by neck disability index

    4 weeks after randomisation

Secondary Outcomes (7)

  • pain intensity

    12, 24 weeks after randomisation

  • disability

    12, 24 weeks after randomisation

  • global perceived effect

    4,12, 24 weeks after randomisation

  • quality of sleep

    4,12, 24 weeks after randomisation

  • catastrophizing

    4,12, 24 weeks after randomisation

  • +2 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises and manual therapy. Participants will receive 4-6 treatments during 4 weeks.

Other: control

dry needling

EXPERIMENTAL

Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises, manual therapy and dry needling in neck muscles. Participants will receive 4-6 treatments during 4 weeks. Participants will receive 4-6 treatments during 4 weeks.

Other: dry needling

Interventions

controlOTHER

Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises and manual therapy. Participants will receive 4-6 treatments during 4 weeks.

Also known as: active control
Control

Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises, manual therapy and dry needling in neck muscles. Participants will receive 4-6 treatments during 4 weeks.

dry needling

Eligibility Criteria

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

You may qualify if:

  • able to speaking and reading in Portuguese, severity of the symptoms at least 3 points on 0-10 numeric pain rating and at least 14% disability on Neck Disability Index.

You may not qualify if:

  • history of whiplash associated injuries, fibromyalgia, cervical spine symptoms of radiculopathy or myelopathy, use of anticoagulant medication, pregnancy, history of spinal surgeries and "red flags" (spinal fracture, inflammatory diseases, tumor, fracture, rheumatoid arthritis, osteoporosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFCSPA

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Neck PainMotor Activity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Fábio F Stieven, Master

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 7, 2016

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

March 1, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations