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

Low Back Pain Clinical Trial

Official title:

A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760887
• Other study ID #: StAmbroseU sensory
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2018
• Source: St. Ambrose University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	St. Ambrose university	Davenport	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
St. Ambrose University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Back Pain Rating	Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)	Change from baseline to following treatment immediately upon completion of initial session
Primary	Low Back Pain Rating	Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)	Change from end of treatment initial session to 2-4 days
Primary	Lumbar Flexion	Active trunk forward flexion measured in cm (finger tips to floor)	Change from baseline to treatment immediately upon completion of initial session
Primary	Lumbar Flexion	Active trunk forward flexion measured in cm (finger tips to floor)	Change from end of treatment initial session to 2-4 days
Primary	Straight Leg Raise	Neurodynamic measurement of leg raise (lower limb tension test)	Change from baseline to treatment immediately upon completion of initial session
Primary	Straight Leg Raise	Neurodynamic measurement of leg raise (lower limb tension test)	Change from end of treatment initial session to 2-4 days