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Procedure

Manual Therapy for Chronic Neck Pain (SS-MECH Trial)

N/A

Recruiting

Led By Chad E Cook

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age and older

experience ongoing neck pain of ≥3 on a 10-point scale for most days of the previous 3-months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate how manual therapy and exercise treatments affect chronic neck pain. It will compare specific and shared mechanisms between the two treatments to see what influences outcomes.

Who is the study for?

This trial is for adults 18 and older who have had neck pain rated at least a 3 out of 10 nearly every day for the past three months or more, without another diagnosis explaining the pain.

What is being tested?

The study compares specific effects of manual therapy to exercise in treating chronic neck pain. It also examines 'shared' mechanisms common to both treatments to see which influences outcomes more.

What are the potential side effects?

While not explicitly listed, manual therapy and exercise may cause temporary discomfort, soreness, or aggravation of existing pain initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had neck pain of 3 or more out of 10 for most days in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Patient Health Engagement Scale

Change in the PROMIS 29.2.

Change in the University of Washington Pain-Related Self Efficacy Scale short form

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Manual therapy treatmentExperimental Treatment1 Intervention

Manual therapy treatments will consist of global soft tissue stretching of the upper trapezius, occipital muscles, levator scapula, and scalene muscles as the patient lies in supine. Non-thrust manipulation will consist of unilateral or central posterior-anterior accessory movements (PAIVMs) to the cervical and upper thoracic segments (in prone) at the most symptomatic levels. Passive physiological intervertebral movements of rotation will be performed in supine, as a mechanism to reduce pain and increase range of motion. Individuals with chronic neck pain randomized to the manual therapy arm, will be assigned a HEP twice daily that will consist of cervical rotations with belt or equivalent, side flexion with belt or equivalent, self-stretching exercises that are designed to target the upper thoracic musculature, and corner wall stretches.

Group II: Resisted exercise treatmentActive Control1 Intervention

In-clinic exercises will consist of chin retractions in sitting, supine clock isometric resistance, supine anterior neck flexion exercises that target the deep neck flexors, prone neck extensor exercises (with concurrent chin retraction), and lateral neck raises (bilaterally). The study team will also target the mid and upper thoracic region by performing upright rows, supine chest raises that target the mid-scapular muscles and the paraspinal muscles, prone "I, T, and Y" exercises, and proprioceptive neuromuscular facilitation exercises using a bar or a cane. Individuals randomized to the resistance exercise arm will be assigned a HEP twice daily that will consist of chin retractions in sitting, supine anterior neck flexion exercises, and elastic band rows that replicate the upright rows performed in the clinic.

0 / 2Eligibility criteria met