Health TrialsbyHealthPanel

Chiropractic Care for Chronic Neck Pain: A Pilot Study

ConditionNeck Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital

About this trial

This pilot randomized controlled trial will evaluate the feasibility and preliminary clinical effects of multimodal chiropractic care for adults with chronic neck pain. Forty participants will be randomized to receive either multimodal chiropractic care plus enhanced usual care or enhanced usual care alone. Feasibility outcomes include recruitment, retention, adherence, and safety. Clinical outcomes include pain intensity, neck-related disability, physical and psychological function, and quality of life. Exploratory electroencephalography (EEG) and gait assessments will examine potential neurophysiological and biomechanical biomarkers associated with treatment response.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Currently receiving chiropractic care or have received chiropractic care within the past 12 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multimodal chiroprctic care

    Procedure/Surgery

    10 visits over 16 weeks including spinal manipulation/mobilization, soft tissue therapy, exercise, and education. Participants receive 10 visits of multimodal chiropractic care over 16 weeks in addition to enhanced usual care. Care may include spinal manipulation or mobilization, soft tissue therapy, therapeutic exercise, and education delivered by licensed chiropractors.

  • Enahnced usual care

    Behavioral

    Educational materials, usual medical care, biweekly check-in calls. Participants continue their usual medical care and receive educational materials for neck pain self-management and biweekly check-in calls from study staff.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Multimodal chiropractic careExperimental treatment 2 interventions
Group B: Enhanced usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recrutiment feasibility

Number of particpants enrolled within the recruitment period

Time frame
12 months
2

Retention/completion rate

Proportion of participants completing assessments

Time frame
16 and 24 weeks
3

Intervention Adherence

Percentage attending ≥ 70% chiropractic sessions

Time frame
16 weeks

Secondary outcomes

1

Clinical outcomes

Neck pain intensity, Neck Pain Disability Index, Promis 29, Bothersomeness of Pain, Pain on Movement

Time frame
baseline, 16 and 24 weeks
2

Biomarkers / mechanistic

Peak alpha frequency ERP amplitudes Gait speed and stride time variability Stride length Dual task cost (gait speed and variability)

Time frame
baseline and 16 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Palmer College of Chiropractic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: