Neck PainNCT06275074
Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance
A study testing Dry Needling and Therapeutic Exercise in people with Neck Pain and Sleep Disturbance, run by Mayo Clinic at 1 site in United States.
Trial summary
Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain, Sleep Disturbance
- What is being tested?
- Dry Needling and Therapeutic Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous surgery to the neck or thoracic spine
- Central nervous system disorders
- Systemic joint disease (e.g. rheumatoid arthritis)
- Infection
- Cancer
- Raynaud's disease
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic - Motion Analysis Lab
Rochester, Minnesota, 55905
About this study
Official title: Effects of Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance - A Pilot Study
Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.
Read the 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.
- Conditions
- Neck Pain, Sleep Disturbance
- Being tested
- Dry Needling, Therapeutic Exercise
- Keywords
- Needling, Sleep Disturbance, Chronic pain, Neck Pain, Actigraphy, Physical Therapy, Feasibility
- Medical subject headings
- Neck Pain, Parasomnias, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
Insertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles
Therapeutic ExerciseOther
Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling and Therapeutic Exercise | Experimental | Not described Receives: Procedure: Dry Needling; Other: Therapeutic Exercise |
| Therapeutic Exercise Alone | Active comparator | Not described Receives: Other: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
Sleep Duration
Total sleep time and Sleep latency via wrist actigraphy
Measured: 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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start14 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray M. Lunasin, Mayo Clinic
- Investigators
- Ray Lunasin, P.T., D.P.T., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275074
- Sponsor's protocol ID
- 23-007716
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance - A Pilot Study
- ClinicalTrials.gov ID
- NCT06275074
- Acronym / sponsor ID
- 23-007716
- Conditions
- Neck Pain, Sleep Disturbance
- Keywords
- Needling, Sleep Disturbance, Chronic pain, Neck Pain, Actigraphy, Physical Therapy, Feasibility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling and Therapeutic Exercise | Experimental | Procedure: Dry Needling, Other: Therapeutic Exercise |
| Therapeutic Exercise Alone | Active comparator | Other: Therapeutic Exercise |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Previous surgery to the neck or thoracic spine
- Central nervous system disorders
- Systemic joint disease (e.g. rheumatoid arthritis)
- Infection
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingInsertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles | Procedure or surgery | Dry Needling and Therapeutic Exercise |
| Therapeutic ExerciseTherapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance. | Other | Dry Needling and Therapeutic Exercise, Therapeutic Exercise Alone |
Primary outcome
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.
2 secondary outcomes
Sleep Duration
Time frame: 5 weeks
Sleep Quality
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Clinical trial webpage of studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray Lunasin, P.T., D.P.T. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Therapeutic Exercise in people with Neck Pain and Sleep Disturbance, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant retention rate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.