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

NCT03760887 | Completed

• 1 other identifier: StAmbroseU sensory
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low back pain; Sensory; Tactile; Education

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Lumbar Flexion

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

  Change from baseline to treatment immediately upon completion of initial session

• Lumbar Flexion

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

  Change from end of treatment initial session to 2-4 days

• Straight Leg Raise

  Neurodynamic measurement of leg raise (lower limb tension test)

  Change from baseline to treatment immediately upon completion of initial session

• Straight Leg Raise

  Neurodynamic measurement of leg raise (lower limb tension test)

  Change from end of treatment initial session to 2-4 days

Study Arms (2)

No Home Sensory training

SHAM COMPARATOR

Patients who perform a home exercise program only

Other: Home exercise program only

Home sensory training

EXPERIMENTAL

Patients who perform home exercise and home sensory training

Other: Home exercise program and home program of sensory discrimination

Interventions

Home exercise program only OTHER

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

No Home Sensory training

Home exercise program and home program of sensory discrimination 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.

Home sensory training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Ambrose University: lead

Study Sites (1)

St. Ambrose university

Davenport, Iowa, 52803, United States

Location

Related 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)

  BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Farrell

  St. Ambrose University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were randomly assigned to one of two groups (control or experimental).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 30, 2018
• Study Start: June 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: April 23, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)