A Study of Effect of Dry Needling for Chronic Neck Pain

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05860751
• Other study ID #: 22-009645
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Behavioral:
• Home Exercise Program
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

Procedure:
• Dry Needling
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in sleep duration	Number of minutes in sleep measured using a consumer-grade sleep tracking device.	Baseline, 5 weeks
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials