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

Effects of Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance - A Pilot Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Neck Pain; Sleep Disturbance
• Intervention / Treatment: Procedure: Dry Needling; Other: Therapeutic Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Motion Analysis Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Needling and Therapeutic Exercise	Procedure: Dry Needling; Insertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles; Other: Therapeutic Exercise; Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance.
Active Comparator: Therapeutic Exercise Alone	Other: Therapeutic Exercise; Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant retention rate	One variable to be assessed to determine feasibility is retention rate of participants recruited and enrolled. The retention rate of participants will be calculated as follows: Retention rate = (Number of patients completing the study / Number of patients initially enrolled) x 100. Feasibility will be determined with 4-week attrition rate is less than 20%	1 year
Participant intervention adherence	One variable to be assessed to determine feasibility is intervention adherence. Adherence to therapeutic exercise program given to all participants will be assessed with an exercise diary to be completed by the participants to track exercise compliance. A new diary will be provided on a weekly basis to maintenance of records.	1 year
Number of adverse responses to treatment	Occurrence of adverse responses to treatment will be accounted for at each subsequent visit after initial treatment administered (visits 3-6). Patients will be asked to complete an intake form that will inquire about their experience post-intervention and provide examples of common adverse responses to determine if such events occurred for each respective participant.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Duration	Total sleep time and Sleep latency via wrist actigraphy	5 weeks
Sleep Quality	Sleep quality will be measured with the use of the Pittsburgh Sleep Quality Index (PSQI). There are seven components that range in scores of 0-3. Total scores range from 0-21 with higher scores indicating worse sleep quality.	13 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability Level	Disability level will be measured with the Neck Pain Disability Index (NDI). There are ten questions with a range of scores of 0-5. Total possible scores range from 0-50 or 0%-100% with higher scores indicating greater disability level.	13 weeks
Pain Level	Pain level will be measured using the numerical pain rating scale (NPRS). It is an 11-point numeric scale ranging from '0' representing "no pain" to '10' representing "worst pain imaginable."	13 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ray Lunasin, P.T., D.P.T., Mayo Clinic

Publications and helpful links

Helpful Links

• Clinical trial webpage of study

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Chronic pain; Physical Therapy; Neck Pain; Actigraphy; Sleep Disturbance; Needling
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parasomnias; Chronic Pain; Neck Pain; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy; Dry Needling
• Other Study ID Numbers: 23-007716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No