Effects of Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance - A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Dry Needling
- Conditions
- Neck Pain
- Sponsor
- Mayo Clinic
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Participant retention rate
- Status
- Active, not recruiting
- Last Updated
- 16 days ago
Overview
Brief Summary
Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.
Detailed 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.
Investigators
Ray M. Lunasin
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
- •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
Arms & Interventions
Dry Needling and Therapeutic Exercise
Intervention: Dry Needling
Dry Needling and Therapeutic Exercise
Intervention: Therapeutic Exercise
Therapeutic Exercise Alone
Intervention: Therapeutic Exercise
Outcomes
Primary Outcomes
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%
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.
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
- Sleep Duration(5 weeks)
- Sleep Quality(13 weeks)