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

• Sponsor: St. Ambrose University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03758807
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 14.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Manual Therapy; Education	Other: Manual Therapy with Traditional Biomechanical Explanation; Other: Manual Therapy with Neuroplastiicity Explanation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Control TrialRandomized Control Trial
• Masking: Single (Participant)
• Masking Description: Patients were randomly assigned to one of two treatment groups
• Primary Purpose: Treatment
• Official Title: A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Passive treatment Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.	Other: Manual Therapy with Traditional Biomechanical Explanation; Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..
Experimental: Active Treatment Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.	Other: Manual Therapy with Neuroplastiicity Explanation; Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.

Outcome Measures

Primary Outcome Measures

1. Low Back Pain Rating [Change from baseline to initial treatment]

   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. LBP is reported to be 2.0.

2. 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.

3. Lumbar flexion [Change from baseline to initial treatment]

   Active trunk forward flexion in cm (distance finger tips to floor)

4. Lumbar flexion [Change from initial treatment to 2-4 days]

   Active trunk forward flexion in cm (distance finger tips to floor)

5. Straight Leg Raise [Change from baseline to initial treatment]

   Neurodynamic Measurement of Leg Raise (lower limb tension test)

6. Straight Leg Raise [Change from initial treatment to 2-4 days]

   Neurodynamic Measurement of Leg Raise (lower limb tension test)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kevin Farrell	Davenport	Iowa	United States	52803

Sponsors and Collaborators

• St. Ambrose University

Investigators

• Principal Investigator: Kevin Farrell, St. Ambrose University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kevin Farrell, Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy, St. Ambrose University
• ClinicalTrials.gov Identifier: NCT03758807
• Other Study ID Numbers: StAmbroseUactive passive
• First Posted: Nov 29, 2018
• Last Update Posted: Apr 23, 2019
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kevin Farrell, Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy, St. Ambrose University: Low back pain; Manual Therapy; Education; Neuroplasticiy
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Apr 23, 2019