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NCT Number: NCT06275074

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neck Pain Chronic Pain Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic - Motion Analysis Lab

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

dry needling

Procedure

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

Therapeutic exercise

Other

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

Primary outcomes

  1. Participant retention rate

    Time frame: 1 year

    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%

  2. Participant intervention adherence

    Time frame: 1 year

    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.

  3. Number of adverse responses to treatment

    Time frame: 1 year

    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.

Secondary outcomes

  1. Sleep Duration

    Time frame: 5 weeks

    Total sleep time and Sleep latency via wrist actigraphy

  2. Sleep Quality

    Time frame: 13 weeks

    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.

Other outcomes

  1. Disability Level

    Time frame: 13 weeks

    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.

  2. Pain Level

    Time frame: 13 weeks

    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."

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Feb 23, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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