Back to resultsA Study of Effect of Dry Needling for Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Exercise Program
Dry Needling
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise and dry needling
Arm Description
Subjects will complete a 5 day a week exercise program and 1 session per week standard of care dry needling for 4 weeks.
Outcomes
Primary Outcome Measures
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.
Change in sleep duration
Number of minutes in sleep measured using a consumer-grade sleep tracking device.
Secondary Outcome Measures
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."
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%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05860751
Brief Title
A Study of Effect of Dry Needling for Chronic Neck Pain
Official Title
The Effect of Dry Needling on Sleep Quality, Pain Intensity, and Function in Individuals With Chronic Neck Pain and Sleep Disturbance: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
May 10, 2024 (Anticipated)
Study Completion Date
May 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise and dry needling
Arm Type
Experimental
Arm Description
Subjects will complete a 5 day a week exercise program and 1 session per week standard of care dry needling for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Home Exercise Program
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Dry Needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in sleep quality
Description
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.
Time Frame
Baseline, 5 weeks
Title
Change in sleep duration
Description
Number of minutes in sleep measured using a consumer-grade sleep tracking device.
Time Frame
Baseline, 5 weeks
Secondary Outcome Measure Information:
Title
Change in pain level
Description
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."
Time Frame
Baseline, 5 weeks
Title
Change in dysfunction
Description
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%.
Time Frame
Baseline, 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Lunasin, PT, DPT
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System
City
Austin
State/Province
Minnesota
ZIP/Postal Code
55912
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Effect of Dry Needling for Chronic Neck Pain
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