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Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry Needling and Therapeutic Exercise | Experimental |
| |
| Therapeutic Exercise Alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry Needling | Procedure | Insertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Duration | Total sleep time and Sleep latency via wrist actigraphy | 5 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Level |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ray Lunasin, P.T., D.P.T. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Motion Analysis Lab | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Clinical trial webpage of study | View source |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D020447 | Parasomnias |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Outcome assessors will be blinded to group assignment of participants.
| Therapeutic Exercise | Other | Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance. |
|
| 13 weeks |
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 |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |