A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain; Education; Manual Therapy
• Interventions: Other: Manual Therapy with Neuroplastiicity Explanation; Other: Manual Therapy with Traditional Biomechanical Explanation

• Registration Number: NCT03758807
• Lead Sponsor: St. Ambrose University

Brief Summary

To determine if there is any carry over difference between the type of education provided about common treatment techniques for patients with low back pain. This will be looked at right after treatment and when patients return on their second visit after they do a common exercise program for a few days.

Detailed Description

Prior clinical trials have shown that patients respond differently to different explanations about interventions performed. A recent randomized clinical trial demonstrated that a 10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's) with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate, significant improvement in straight leg raise (SLR) and pain for patients with chronic low back pain. However, there is a need to examine whether there is any carry over (48-96 hours) or if utilizing a home exercise program (HEP), aimed at increasing the various sensory process applied in the clinic, produces any carry over. This will be looked at in patients with who are provided different explanations about common back treatment techniques to see if there will be any change in pain rating or back and leg movement.

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-29
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• adults over the age of 18
• patients presenting at PT with a primary complaint of LBP
• LBP being present for 6 months or more
• fluent in English
• willing to participate in the study.

Exclusion Criteria

• under age 18
• not able to read/understand the English language
• prisoners
• no medical issues precluding physical therapy treatment (red flags)
• no medical precautions to the use of manual therapy (metal, skin lesions, etc.)
• prior spine surgery
• unable to lay prone for the treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	Manual Therapy with Neuroplastiicity Explanation	Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.
Passive treatment	Manual Therapy with Traditional Biomechanical Explanation	Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.

Primary Outcome Measures

Name	Time	Method
Straight Leg Raise	Change from initial treatment to 2-4 days	Neurodynamic Measurement of Leg Raise (lower limb tension test)
Lumbar flexion	Change from initial treatment to 2-4 days	Active trunk forward flexion in cm (distance finger tips to floor)
Low Back Pain Rating	Change from initial treatment to 2-4 days	Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.

Trial Locations

Locations (1)

Kevin Farrell; 🇺🇸 Davenport, Iowa, United States