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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275074
• Other study ID #: 23-007716
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Ray Lunasin, P.T., D.P.T.
• Phone: 507-538-0839
• Email: lunasin.ray[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dyssomnias
• Neck Pain
• Parasomnias
• Sleep Disturbance

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic - Motion Analysis Lab	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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	Sleep Duration	Total sleep time and Sleep latency via wrist actigraphy	5 weeks
Secondary	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