Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance

NCT ID: NCT06275074

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2026-03-01

Brief Summary

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Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.

Detailed Description

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The purpose of this pilot study is to determine the feasibility of a large randomized clinical trial (RCT) which aims to investigate the effects of dry needling (DN) in addition to therapeutic exercise (TE) on sleep duration and quality in patients with chronic neck pain (CNP) and sleep disturbance (SD). Specifically, the objective is to explore feasibility of a study protocol and examine the preliminary data of a small sample size for the effectiveness of DN and TE for individuals with CNP and SD to determine effect size of the intervention.

Conditions

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Neck Pain Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors will be blinded to group assignment of participants.

Study Groups

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Dry Needling and Therapeutic Exercise

Group Type EXPERIMENTAL

Dry Needling

Intervention Type PROCEDURE

Insertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles

Therapeutic Exercise

Intervention Type OTHER

Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance.

Therapeutic Exercise Alone

Group Type ACTIVE_COMPARATOR

Therapeutic Exercise

Intervention Type OTHER

Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance.

Interventions

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Dry Needling

Insertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles

Intervention Type PROCEDURE

Therapeutic Exercise

Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Neck pain lasting greater than 3 months 28,29
* Age: 18-75 years
* Presence of sleep disturbance - to be defined as a score ≥ 8 on the Insomnia Severity Index
* Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria

* Previous surgery to the neck or thoracic spine
* Central nervous system disorders
* Systemic joint disease (e.g. rheumatoid arthritis)
* Infection
* Cancer
* Raynaud's disease
* Pregnancy
* Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
* Insufficient English-language skills to complete all questionnaires.
* Contraindications to dry needling:

* Presence of needle phobia
* History of abnormal reaction to needling or injection
* History of bleeding disorder (e.g., current anticoagulant therapy or known thrombocytopenia)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ray M. Lunasin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ray Lunasin, P.T., D.P.T.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic - Motion Analysis Lab

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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23-007716

Identifier Type: -

Identifier Source: org_study_id

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