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

Dry-needling Added to Physical Therapy for Treating Patients With Chronic Non-specific Neck Pain: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02927977
Enrollment
116
Registered
2016-10-07
Start date
2016-12-31
Completion date
2018-03-31
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

dry needling, exercise, manual therapy

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.

Interventions

OTHERcontrol

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.

OTHERdry needling

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.

Sponsors

Federal University of Health Science of Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
pain intensity4 weeks after randomisationmeasured by 11-point numeric rating scale
disability4 weeks after randomisationmeasured by neck disability index

Secondary

MeasureTime frameDescription
global perceived effect4,12, 24 weeks after randomisationmeasured by global perceived rating scale
quality of sleep4,12, 24 weeks after randomisationmeasure by Pittsburgh quality index
pain intensity12, 24 weeks after randomisationmeasured by 11-point numeric rating scale
self-efficacy4,12, 24 weeks after randomisationmeasured by The Pain Self-Efficacy Questionnaire
adverse events24h, 72h and four weeks after randomisationrecord of the adverse events
catastrophizing4,12, 24 weeks after randomisationmeasure by pain catastrophizing scale
disability12, 24 weeks after randomisationmeasured by neck disability index

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026