Dry Needling, Manual Therapy and Exercise for Neck Pain Management

Neck Pain, Posterior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607459
• Other study ID #: PhD-MML
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: August 2023
• Source: Camilo Jose Cela University
• Contact: Juan Antonio Valera-Calero, PhD
• Phone: 653 766 841
• Email: javalera[@]ucjc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neck Pain
• Neck Pain, Posterior

Intervention

Other:
• Dry Needling
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

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

Other:
• Manual Therapy
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 Needling
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.

Locations

Country	Name	City	State
Spain	Juan Antonio Valera-Calero	Alcorcón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Camilo Jose Cela University	Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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