Neck Pain, Sleep Disturbance
Conditions
Keywords
Needling, Sleep Disturbance, Chronic pain, Neck Pain, Actigraphy, Physical Therapy, Feasibility
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.
Interventions
PROCEDUREDry Needling
Insertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles
OTHERTherapeutic Exercise
Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to group assignment of participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant retention rate | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Duration | 5 weeks | Total sleep time and Sleep latency via wrist actigraphy |
| Sleep Quality | 13 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRay Lunasin, P.T., D.P.T.
Mayo Clinic
Outcome results
None listed