Dry Needling, Manual Therapy and Exercise for Neck Pain Management

Camilo Jose Cela University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neck Pain, Posterior

Interventions

Dry NeedlingOTHER

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

Therapeutic ExerciseBEHAVIORAL

Patients will include a supervised therapeutic exercise program in their daily life, based on strengthening exercises for neck muscles.

Manual TherapyOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Juan Antonio Valera-Calero

Alcorcón, Madrid, Spain

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Twelve months follow-up

Secondary Outcomes

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)

Time frame: 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)

Data from ClinicalTrials.gov

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Patients will receive a manual compression (30 seconds) over myofascial trigger points located at the upper trapezius muscle, scalene muscles and cervical multifidus muscle.

Sham Dry NeedlingOTHER

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.

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: Baseline

Hospital Anxiety and Depression Scale

Time frame: One month follow-up

Hospital Anxiety and Depression Scale

Time frame: Three months follow-up

Hospital Anxiety and Depression Scale

Time frame: Six months follow-up

Hospital Anxiety and Depression Scale

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.