A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain

NCT ID: NCT03760887

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2018-12-30

Brief Summary

To determine if there is any carry over difference with sensation training to the low back for patients with low back pain with the addition of a training at home. This will be looked at to see if there is a difference in pain or back / leg movement right after the training and in a few days after doing some exercises at home.

Detailed Description

In a previous case series patients with chronic Low Back Pain (LBP) who received tactile acuity training to their lower back in the absence of movement, experienced immediate positive changes in pain ratings and spinal movements. These changes, however, where only measured immediate post-intervention. This study aims to use a similar design of sensory discrimination for LBP, but will include a sensory discrimination home exercise program and compare groups at a follow-up visit for any difference between groups (48-96 hours) of the immediate changes. Changes will be assessed for pain and back and leg movement.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

No Home Sensory training

Patients who perform a home exercise program only

Group Type: SHAM_COMPARATOR

Home exercise program only

Intervention Type: OTHER

After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only

Home sensory training

Patients who perform home exercise and home sensory training

Group Type: EXPERIMENTAL

Home exercise program and home program of sensory discrimination

Intervention Type: OTHER

After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.

Interventions

Home exercise program only

After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only

Intervention Type: OTHER

Home exercise program and home program of sensory discrimination

After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adults over the age of 18
• patients presenting at PT with a primary complaint of LBP
• LBP being present for 3 months or more
• fluent in English
• willing to participate in the study
• They also will need someone who can assist with a sensory discrimination HEP.

Exclusion Criteria

• under age 18
• not able to read/understand the English language
• prisoners
• no medical issues precluding physical therapy treatment (red flags)
• if they had undergone spinal surgery
• if they had any skin or medical condition preventing them from receiving tactile stimuli on the lower back or had specific movement-based precautions, i.e., no active spinal flexion. - Patients presenting with leg pain only
• Patients with neurological deficit only in the lower extremity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Ambrose University

OTHER

Sponsor Role: lead

Responsible Party

Kevin Farrell

Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Farrell

Role: PRINCIPAL_INVESTIGATOR

St. Ambrose University

Locations

St. Ambrose university

Davenport, Iowa, United States

Countries

United States

References

Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Welding M (2015) Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy 43(2)

Reference Type: BACKGROUND

Other Identifiers

StAmbroseU sensory

Identifier Type: -

Identifier Source: org_study_id