Pragmatically Applied Orthopedic Manual Therapy and Dry Needling for Low Back Pain.

Summary

Both orthopedic manual therapy (OMT) and dry needling (DN) have been shown to be effective at reducing pain and disability for individuals with low back pain (LBP). It is unclear if one intervention, or in combination with one another, is more effective. The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with combined OMT + DN on pain and disability for patients with LBP. Both within and between group effects will be presented.

Patient factors such as; generalized anxiety disorder, depression, fear-avoidance behaviors, pain catastrophizing, and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP. Moreover, sleep deprivation and pain related fear of movement functionally can change a person's pain inhibitory pathways leading to hyeralgesia. These factors have been individually analyzed regarding their effects on pain related outcomes, which limits our understanding of how clustering patient factors might affect recovery. A secondary aim will involve determining the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN and/or manual therapy.

Conditions

• Low Back Pain, Mechanical

Interventions

OTHER

Orthopedic Manaual Therapy

Can include either spinal mobilizations or spinal manipulation therapy targeting the stiff or symptomatic level of the lumbar spine. Various types of mobilization or manipulation may be used based on the therapists clinical reasoning. The therapist will determine which technique and dosage parameters for each subject based on individual patient clinical data. Common mobilizations techniques involve gently and repeatedly applying pressure over different parts of the patient's spine that is associated with their symptoms. For a manipulation, the patient will be positioned in side-lying position. The therapist will then position the patient further to target the symptomatic level. The patient is asked to take a deep breathe in and out. The therapist will slowly add pressure through the trunk and apply a fast but small thrust motion toward the table.

OTHER

Dry Needling

dry needling both sides of the symptomatic level(s) of the lumbar spine as well as needling other areas in the lower extremity and pelvis based on the results of their clinical evaluation and/or the subjects presenting symptoms. Dry needling involves the insertion of a monofilament needle (nothing is injected) into symptomatic soft tissue. The therapist will determine which technique and dosage parameters for each subject based on individual patient clinical data.

OTHER

Home exercise program

5 exercises will be selected from 10 options intended to reinforce the improvements made from treatment.

OTHER

Patient education

Patient education on the low back condition, advice to stay active, and home exercise performance.

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• Youngstown State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-31

Primary Completion

2025-12-31

Completion

2025-12-31