Dry Needling, Manual Therapy and Exercise for Neck Pain Management

Study Overview
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Brief Summary
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Since neck pain is the fourth highest disabling condition (with an estimated point prevalence of 20%, lifetime prevalence up to 70% and high recurrence rates), dry needling targeting myofascial trigger points in neck muscles has been proposed as an effective treatment for reducing pain and disability in patients with chronic neck pain. A recent meta-analysis reported whether dry needling could be recommended for this population. Low to moderate evidence suggests that dry needling can be effective at the short-term, but its effects on pressure pain sensitivity or cervical range of motion are limited.

Official Title
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Efficacy of Adding Dry Needling to a Manual Therapy and Therapeutic Exercise Interventions for Managing Neck Pain Populations: A Randomized Controlled Trial

Conditions
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Neck Pain, Posterior

Intervention / Treatment
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* Other: Dry Needling
* Behavioral: Therapeutic Exercise
* Other: Manual Therapy
* Other: Sham Dry Needling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be between 18 and 65 years old To have been experiencing unilateral neck pain for at least 3 months To have a Neck Disability Index (NDI) score >8 To have a Visual Analogue Scale (VAS) score >3 To have at least one active MTrP located in the upper trapezius or cervical multifidus muscles Exclusion Criteria: History of whiplash injury Previous cervical surgery Cervical radiculopathy or myelopathy Diagnosis of fibromyalgia Additional analgesic treatments during the study (e.g. physiotherapy or drugs) Psychiatric disorders Any contraindication to the interventions proposed (e.g. fear of needles or anticoagulants)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel, controlled and single-blinded clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Needling Group<br>This group will receive dry needling, manual therapy (consisting of a manual compression over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus) and therapeutic exercise interventions | Other: Dry Needling<br>* Dry needling consists of a skilled intervention which uses a thin filiform needle (as those used in acupuncture) to penetrate the skin and stimulate underlying myofascial trigger points (defined as a hyperirritable spot in skeletal muscle that is associated with a hypersensitive palpable nodule in a taut band which is painful on manual compression and can give rise to characteristic referred pain, referred tenderness, motor dysfunction and autonomic phenomena.) This intervention will be performed targeting the upper trapezius and cervical multifidus muscles<br>Behavioral: Therapeutic Exercise<br>* Patients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles.<br>Other: Manual Therapy<br>* Patients will receive a manual compression (30 seconds) over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus muscle.<br>|
| Active Comparator: Sham Dry Needling Group<br>This group will receive manual therapy (consisting of a manual compression over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus), therapeutic exercise interventions and a previously described sham dry needling intervention. | Behavioral: Therapeutic Exercise<br>* Patients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles.<br>Other: Manual Therapy<br>* Patients will receive a manual compression (30 seconds) over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus muscle.<br>Other: Sham Dry Needling<br>* For the sham DN intervention, a similar approach will be used, but the skin will be not pierced since the material used will be a telescopic Park's sham device. The guide tube will be pressed against the skin mark and the sham needle will be allowed to drop. The handle will be tapped briskly, but the (blunted) needle tip will not not break the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable) | Baseline | 
| Visual Analogue Scale | A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable) | One month follow-up | 
| Visual Analogue Scale | A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable) | Three months follow-up | 
| Visual Analogue Scale | A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable) | Six months follow-up | 
| Visual Analogue Scale | A 100mm visual analogue scale will be used. The patient will indicate the level of pain intensity from 0 (no pain) to 10 (the worst pain imaginable) | Twelve months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburg Sleeping Quality Index | This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality) | Baseline | 
| Pittsburg Sleeping Quality Index | This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality) | One month follow-up | 
| Pittsburg Sleeping Quality Index | This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality) | Three months follow-up | 
| Pittsburg Sleeping Quality Index | This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality) | Six months follow-up | 
| Pittsburg Sleeping Quality Index | This is a validated self-reported questionnaire assessing the sleeping quality. Scores range from 0 (best sleep quality) to 21 (worst sleep quality) | Twelve months follow-up | 
| Hospital Anxiety and Depression Scale | This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels. | Baseline | 
| Hospital Anxiety and Depression Scale | This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels. | One month follow-up | 
| Hospital Anxiety and Depression Scale | This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels. | Three months follow-up | 
| Hospital Anxiety and Depression Scale | This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels. | Six months follow-up | 
| Hospital Anxiety and Depression Scale | This is a validated self-reported questionnaire assessing the level of anxiety and depression in two subscales (HADS-A and HADS-D). Scores for each scale range from 0 to 21 points, where lower scores are associated with lower depressive and anxiety levels. | Twelve months follow-up | 
| Neck Disability Index | This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability). | Baseline | 
| Neck Disability Index | This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability). | One month follow-up | 
| Neck Disability Index | This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability). | Three months follow-up | 
| Neck Disability Index | This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability). | Six months follow-up | 
| Neck Disability Index | This is a validated self-reported questionnaire assessing the neck pain disability. Scores range from 0 (absence of disability) to 100 (worst disability). | Twelve months follow-up | 
| Tampa Scale for Kinesiophobia | The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 complete disagreement and 4 complete agreement (total score from 0 to 44), where higher scores indicate greater kinesiophobia. | Baseline | 
| Tampa Scale for Kinesiophobia | The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 complete disagreement and 4 complete agreement (total score from 0 to 44), where higher scores indicate greater kinesiophobia. | One month follow-up | 
| Tampa Scale for Kinesiophobia | The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 complete disagreement and 4 complete agreement (total score from 0 to 44), where higher scores indicate greater kinesiophobia. | Three months follow-up | 
| Tampa Scale for Kinesiophobia | The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 complete disagreement and 4 complete agreement (total score from 0 to 44), where higher scores indicate greater kinesiophobia. | Six months follow-up | 
| Tampa Scale for Kinesiophobia | The scale consist of 11 items where patients have to choose in a 4-point Likert scale how much they agree with each item, being 1 complete disagreement and 4 complete agreement (total score from 0 to 44), where higher scores indicate greater kinesiophobia. | Twelve months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Needling