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Procedure

Manual therapy treatment 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

SS-MECH Trial 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.Check my eligibility

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.See study design

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.

SS-MECH Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

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

SS-MECH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in Cervical Range of motion device (CROM) in flexion using a CROM

Changes in Cervical Range of motion device in extension using a CROM

Changes in Cervical Range of motion device in side flexion using a CROM

+6 more

Secondary outcome measures

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

SS-MECH 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

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,364 Previous Clinical Trials

3,420,516 Total Patients Enrolled

University of Colorado, DenverOTHER

1,738 Previous Clinical Trials

2,149,400 Total Patients Enrolled

Saint-Joseph UniversityOTHER

42 Previous Clinical Trials

5,078 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any spots available for this experimental research at the moment?

"As per clinicaltrials.gov, this research study is recruiting participants and was published on December 1st 2023 with the most recent update being on December 13th of that same year."

Answered by AI

What is the targeted recruitment size for this medical experiment?

"Yes, according to the clinicaltrials.gov website, this investigation is actively recruiting participants as of December 13th 2023. The trial was first published on December 1st 2023 and requires 126 volunteers across a single site."

Answered by AI

What are the desired results of this research endeavor?

"This trial's primary goal is to measure changes in cervical range of motion device rotation using a CROM. Secondary objectives include assessing the Working Alliance Inventory (WAI), PROMIS 29.2, and Patient Health Engagement Scale over 3-week period. WAI evaluates collaborative relationship between therapist and client on 36 different criteria; each item scored from 1-7 with higher scores representing better alliance. The PROMIS 29.2 measures pain intensity through 0-10 numeric rating scale while other scales are measured as t score relative to general population mean value 50%. PHE-s consists of 6 items rated from 1-7 where lower"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Specific and Shared Mechanisms Associated With Treatment for Chronic Neck Pain

2024. "Specific and Shared Mechanisms Associated With Treatment for Chronic Neck Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05940012.

All > Neck Pain