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

• ClinicalTrials.gov Identifier: NCT03760887
• Recruitment Status: Completed
• First Posted: November 30, 2018
• Last Update Posted: April 23, 2019
• Sponsor: St. Ambrose University
• Information provided by (Responsible Party): Kevin Farrell, St. Ambrose University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Other: Home exercise program only; Other: Home exercise program and home program of sensory discrimination	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Control Trial
• Masking: Single (Participant)
• Masking Description: Patients were randomly assigned to one of two groups (control or experimental).
• Primary Purpose: Treatment
• Official Title: A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial
• Actual Study Start Date: June 1, 2018
• Actual Primary Completion Date: December 30, 2018
• Actual Study Completion Date: December 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: No Home Sensory training; Patients who perform a home exercise program only	Other: 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
Experimental: Home sensory training; Patients who perform home exercise and home sensory training	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.

Outcome Measures

Primary Outcome Measures :

1. Low Back Pain Rating [ Time Frame: Change from baseline to following treatment immediately upon completion of initial session ]
   Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
2. Low Back Pain Rating [ Time Frame: Change from end of treatment initial session to 2-4 days ]
   Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
3. Lumbar Flexion [ Time Frame: Change from baseline to treatment immediately upon completion of initial session ]
   Active trunk forward flexion measured in cm (finger tips to floor)
4. Lumbar Flexion [ Time Frame: Change from end of treatment initial session to 2-4 days ]
   Active trunk forward flexion measured in cm (finger tips to floor)
5. Straight Leg Raise [ Time Frame: Change from baseline to treatment immediately upon completion of initial session ]
   Neurodynamic measurement of leg raise (lower limb tension test)
6. Straight Leg Raise [ Time Frame: Change from end of treatment initial session to 2-4 days ]
   Neurodynamic measurement of leg raise (lower limb tension test)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Iowa

St. Ambrose university

Davenport, Iowa, United States, 52803

Sponsors and Collaborators

St. Ambrose University

Investigators

• Principal Investigator: Kevin Farrell; St. Ambrose University

More Information

Publications:

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)

• Responsible Party: Kevin Farrell, Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy, St. Ambrose University
• ClinicalTrials.gov Identifier: NCT03760887
• Other Study ID Numbers: StAmbroseU sensory
• First Posted: November 30, 2018
• Last Update Posted: April 23, 2019
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• 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, St. Ambrose University:

Low back pain; Sensory; Tactile; Education

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations