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

NCT ID: NCT02927977

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-03-31

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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

control

Intervention Type: OTHER

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.

dry 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. Participants will receive 4-6 treatments during 4 weeks.

Group Type: EXPERIMENTAL

dry needling

Intervention Type: OTHER

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.

Interventions

control

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

dry 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.

Intervention Type: OTHER

Other Intervention Names

active control

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Fábio Franciscatto Stieven

MsC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fábio F Stieven, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Locations

UFCSPA

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

DRY01

Identifier Type: -

Identifier Source: org_study_id