A Study of Effect of Dry Needling for Chronic Neck Pain

Study Overview
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Brief Summary
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The purpose of this study is to examine whether dry needling in addition to exercises improves sleep quality and sleep duration in individuals with chronic neck pain and sleep disturbance.

Official Title
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The Effect of Dry Needling on Sleep Quality, Pain Intensity, and Function in Individuals With Chronic Neck Pain and Sleep Disturbance: A Pilot Study

Conditions
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Neck Pain

Intervention / Treatment
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* Behavioral: Home Exercise Program
* Procedure: Dry Needling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neck pain lasting greater than 3 months19. Presence of sleep disturbance - to be defined as a score ≥ 8 on the Insomnia Severity Index. Exclusion Criteria: Central nervous system disorders. Signs consistent with nerve root compression (at least 2 of the following had to be diminished for nerve root involvement to be considered: myotomal strength, sensation, or reflexes). Prior surgery to the neck or thoracic spine. Systemic joint disease (e.g. rheumatoid arthritis.) Evidence of red flags (e.g. fracture, infection, tumor, cauda equina syndrome), cancer. Raynaud's disease. Pregnancy. Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus). Workers' compensation or pending legal action regarding their neck pain. 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; Current anticoagulant therapy or known thrombocytopenia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and dry needling<br>Subjects will complete a 5 day a week exercise program and 1 session per week standard of care dry needling for 4 weeks. | Behavioral: Home Exercise Program<br>* Comprised of four exercises aimed to improve postural strength, postural stability, and trunk range of motion; 3 sets of 10 repetitions, 5 days a week<br>Procedure: Dry Needling<br>* Administered for a total of 4 sessions at a frequency of once per week. The target muscles to be needled will include the upper trapezius, infraspinatus, cervico-thoracic junction multifidus, and cervical erector spinae.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quality | Measured using the Pittsburgh Sleep Quality Index (PSQI). Self-report questionnaire that measures general sleep quality. The scoring range is 0-21 with 0-3 scoring for each component. Higher scores indicate worse sleep quality. | Baseline, 5 weeks | 
| Change in sleep duration | Number of minutes in sleep measured using a consumer-grade sleep tracking device. | Baseline, 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level | Measured using the Numerical Pain Rating Scale (NPRS), an 11-point numeric scale ranging from '0' representing no pain to '10' representing worst pain imaginable. | Baseline, 5 weeks | 
| Change in dysfunction | Assessed using the Neck Disability Index (NDI), a self-reported condition-specific functional status questionnaire and consists of 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each item is scored on a scale of 0-5, with the possible total score ranging from 0-50 or 0%-100%. | Baseline, 5 weeks |