Dry Needling, Manual Therapy and Exercise for Neck Pain Management

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Dry Needling

Therapeutic Exercise

Manual Therapy

Sham Dry Needling

About this trial

This is an interventional treatment trial for Neck Pain, Posterior focused on measuring Dry Needling

Eligibility Criteria

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

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)

Sites / Locations

Juan Antonio Valera-CaleroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling Group

Sham Dry Needling Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

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)

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)

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)

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)

Secondary Outcome Measures

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)

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)

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)

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)

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)

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.

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.

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.

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.

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.

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05607459

First Posted

October 28, 2022

Last Updated

August 30, 2023

Sponsor

Camilo Jose Cela University

Collaborators

Universidad Rey Juan Carlos

1. Study Identification

Unique Protocol Identification Number

NCT05607459

Brief Title

Dry Needling, Manual Therapy and Exercise for Neck Pain Management

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Camilo Jose Cela University

Collaborators

Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain, Posterior

Keywords

Dry Needling

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized, parallel, controlled and single-blinded clinical trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dry Needling Group

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Dry Needling Group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Dry Needling

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Therapeutic Exercise

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Manual Therapy

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sham Dry Needling

Intervention Description

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.

Primary Outcome Measure Information:

Title

Visual Analogue Scale

Description

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

Title

Visual Analogue Scale

Description

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

Title

Visual Analogue Scale

Description

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

Title

Visual Analogue Scale

Description

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

Title

Visual Analogue Scale

Description

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 Outcome Measure Information:

Title

Pittsburg Sleeping Quality Index

Description

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

Title

Pittsburg Sleeping Quality Index

Description

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

One month follow-up

Title

Pittsburg Sleeping Quality Index

Description

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

Title

Pittsburg Sleeping Quality Index

Description

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

Title

Pittsburg Sleeping Quality Index

Description

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

Title

Hospital Anxiety and Depression Scale

Description

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

Title

Hospital Anxiety and Depression Scale

Description

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

One month follow-up

Title

Hospital Anxiety and Depression Scale

Description

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

Three months follow-up

Title

Hospital Anxiety and Depression Scale

Description

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

Six months follow-up

Title

Hospital Anxiety and Depression Scale

Description

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

Twelve months follow-up

Title

Neck Disability Index

Description

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

Title

Neck Disability Index

Description

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

Title

Neck Disability Index

Description

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

Title

Neck Disability Index

Description

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

Title

Neck Disability Index

Description

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

Title

Tampa Scale for Kinesiophobia

Description

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.

Time Frame

Baseline

Title

Tampa Scale for Kinesiophobia

Description

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.

Time Frame

One month follow-up

Title

Tampa Scale for Kinesiophobia

Description

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.

Time Frame

Three months follow-up

Title

Tampa Scale for Kinesiophobia

Description

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.

Time Frame

Six months follow-up

Title

Tampa Scale for Kinesiophobia

Description

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.

Time Frame

Twelve months follow-up

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: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Juan Antonio Valera-Calero, PhD

Phone

653 766 841

Email

javalera@ucjc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Antonio Valera Calero, PhD

Organizational Affiliation

Camilo José Cela University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Juan Antonio Valera-Calero

City

Alcorcón

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan Antonio Valera-Calero, PhD

Phone

+34653766841

Email

javalera@ucjc.edu

12. IPD Sharing Statement

Plan to Share IPD

No

Neck Pain, Posterior

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial