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Procedure

Spinal Manipulative Therapy for Neck Pain

N/A

Recruiting

Led By Arin Ellingson, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Ages 18 to 39

Pain intensity >3 (0-10 scale)

Must not have

History of cervical spine surgery

Contraindications to radiation exposure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hr

Summary

"This trial aims to develop a way to measure spinal health using movement patterns, to improve treatments like spinal manipulation therapy. The study will focus on how spinal motions can indicate spinal problems and if therapy can improve

Who is the study for?

This trial is for adults aged 18 to 39 who have been experiencing nonspecific, mechanical neck pain of moderate intensity or higher (more than a 3 on a scale from 0-10) for over three months. It's not suitable for individuals outside this age range or those with different types of neck pain.

What is being tested?

The study aims to see if Spinal Manipulative Therapy (SMT) can correct abnormal neck movements in people with chronic neck pain by comparing it against light massage and no treatment at all. Participants will be randomly assigned to one of these three groups.

What are the potential side effects?

While the document doesn't specify side effects, SMT may sometimes result in temporary discomfort, headaches, tiredness, or worsening of existing symptoms. Light massage is generally well-tolerated but could cause mild soreness.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 39 years old.

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My pain level is above 3 on a scale of 0 to 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my neck spine.

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I cannot be exposed to radiation due to health risks.

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I do not have conditions like neck instability or serious nerve problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hr

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hr

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hr for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Intersegmental and Global Range of Motion

Secondary study objectives

Fear of pain assessment

Neck disability

Neck pain intensity

+5 more

Side effects data

From 2019 Phase 2 trial • 273 Patients • NCT02868034

10%

Increased low back symptoms from treatment

100%

80%

60%

40%

20%

Study treatment Arm

No Further Treatment

Extended SMT

Activating Exercise Component Only

Mobilizing Exercise Component Only

SMT With Activating Exercise Component

SMT With Mobilizing Exercise Component

Activating Exercise and Mobilizing Exercise Components

SMT With Activating Exercise and Mobilizing Exercise Components

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Experimental groupExperimental Treatment1 Intervention

Spinal Manipulative therapy group

Group II: No treatment groupActive Control1 Intervention

No Treatment: participants will be placed in a similar position to the other groups for the same duration, but no treatment or touch will be administered.

Group III: Pseudo sham groupPlacebo Group1 Intervention

Light massage group

0 / 5Eligibility criteria met