search
Back to results

Effectiveness of Dry Needling Adding to Physical Therapy in Patients With Chronic Non-Specific Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
control
dry needling
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring dry needling, exercise, manual therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • UFCSPA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

dry needling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

pain intensity
measured by 11-point numeric rating scale
disability
measured by neck disability index

Secondary Outcome Measures

pain intensity
measured by 11-point numeric rating scale
disability
measured by neck disability index
global perceived effect
measured by global perceived rating scale
quality of sleep
measure by Pittsburgh quality index
catastrophizing
measure by pain catastrophizing scale
self-efficacy
measured by The Pain Self-Efficacy Questionnaire
adverse events
record of the adverse events

Full Information

First Posted
October 5, 2016
Last Updated
November 10, 2018
Sponsor
Federal University of Health Science of Porto Alegre
search

1. Study Identification

Unique Protocol Identification Number
NCT02927977
Brief Title
Effectiveness of Dry Needling Adding to Physical Therapy in Patients With Chronic Non-Specific Neck Pain
Official Title
Dry-needling Added to Physical Therapy for Treating Patients With Chronic Non-specific Neck Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Background: Neck pain is a costly and high prevalent problem. Current evidences show that pain education, exercises and manual therapy are recommended to treat patients with chronic non-specific neck pain, but the use of dry needling has not been studied adequately when in combination with these therapies. Previous trials have shown that dry needling have effectiveness in reducing neck pain in the short and medium term. However, these studies have some limitations as a small sample size and follow-up time reduced. A clinical trial with multimodal treatment method and consistent with clinical practice is needed to determine the effects of dry needling on individuals with non-specific neck pain. Purpose: 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 and compare to individuals who received the multimodal physical therapy rehabilitation program without the use of the dry needling. Design: a randomized single blind placebo controlled trial will be conducted trial in accordance with the CONSORT guidelines. Patients (n=116) with non-specific neck pain will be randomized to receive 1) pain education, manual therapy, and exercise (n=58) or 2) pain education, manual therapy, exercise and dry needling (n=58). Participants will receive 4-6 treatments during 4 weeks. Clinical outcomes (pain intensity, disability,global perceived effect, self-efficacy, quality of sleep and catastrophizing) will be obtained at follow-up appointments at four, twelve and twenty-four weeks after randomisation. Methods: The primary outcome will be pain (measured by 11-point numerical pain rating scale) and disability (measured by the Neck Disability Index) measure four weeks after randomization. Secondary outcome will be pain and disability in twelve and twenty-four weeks after randomization and global perceived effect (measured by global perceived rating scale), self-efficacy (measured by pain self-efficacy questionnaire), quality of sleep (measure by Pittsburgh quality index), catastrophizing (measure by pain catastrophizing scale) measured four weeks, twelve weeks and twenty-four weeks after randomization and and registration of adverse events (24h, 27h and four weeks after randomization). Data Analysis: All outcomes will be assessed following intention-to-treat principles. For each outcome, linear mixed models will be employed containing terms for participant, treatment center, group, time and group by time interaction. Known prognostic factors for increased disability in chronic neck pain will be treated as potential confounders and, in the presence of group imbalance despite random allocation, they will be treated as covariates for all outcomes. For the primary outcomes, a p < 0.05 will be considered statistically significant. For all secondary outcomes, a p < 0.01 will be considered statistically significant. Significance: the results of this study will provide new information about the clinical application of dry needling in additional component for the management of non-specific neck pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
dry needling, exercise, manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
dry needling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
control
Other Intervention Name(s)
active control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain intensity
Description
measured by 11-point numeric rating scale
Time Frame
4 weeks after randomisation
Title
disability
Description
measured by neck disability index
Time Frame
4 weeks after randomisation
Secondary Outcome Measure Information:
Title
pain intensity
Description
measured by 11-point numeric rating scale
Time Frame
12, 24 weeks after randomisation
Title
disability
Description
measured by neck disability index
Time Frame
12, 24 weeks after randomisation
Title
global perceived effect
Description
measured by global perceived rating scale
Time Frame
4,12, 24 weeks after randomisation
Title
quality of sleep
Description
measure by Pittsburgh quality index
Time Frame
4,12, 24 weeks after randomisation
Title
catastrophizing
Description
measure by pain catastrophizing scale
Time Frame
4,12, 24 weeks after randomisation
Title
self-efficacy
Description
measured by The Pain Self-Efficacy Questionnaire
Time Frame
4,12, 24 weeks after randomisation
Title
adverse events
Description
record of the adverse events
Time Frame
24h, 72h and four weeks after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fábio F Stieven, Master
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
UFCSPA
City
Porto Alegre
State/Province
RS
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effectiveness of Dry Needling Adding to Physical Therapy in Patients With Chronic Non-Specific Neck Pain

We'll reach out to this number within 24 hrs