NCT06275074

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Mar 2024Apr 2027

First Submitted

Initial submission to the registry

February 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

March 14, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

February 16, 2024

Last Update Submit

April 14, 2026

Conditions

Neck PainSleep Disturbance

Keywords

NeedlingSleep DisturbanceChronic painNeck PainActigraphyPhysical TherapyFeasibility

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Sleep Duration

    5 weeks

  • Sleep Quality

    13 weeks

Other Outcomes (2)

  • Disability Level

    13 weeks

  • Pain Level

    13 weeks

Study Arms (2)

Dry Needling and Therapeutic Exercise

EXPERIMENTAL
Procedure: Dry NeedlingOther: Therapeutic Exercise

Therapeutic Exercise Alone

ACTIVE COMPARATOR
Other: Therapeutic Exercise

Interventions

Dry NeedlingPROCEDURE

Insertion of filiform needles into cervicothoracic multifidi, upper trapezius, and suboccipital muscles

Dry Needling and Therapeutic Exercise
Therapeutic ExerciseOTHER

Therapeutic exercise program provided to all participants with the aim of addressing periscapular strength and postural edurance.

Dry Needling and Therapeutic ExerciseTherapeutic Exercise Alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic - Motion Analysis Lab

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Neck PainParasomniasChronic Pain

Interventions

Dry NeedlingExercise Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Ray Lunasin, P.T., D.P.T.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to group assignment of participants.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 23, 2024

Study Start

March 14, 2024

Primary Completion

September 1, 2024

Study Completion (Estimated)

April 1, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)