Tactile Acuity in Experimentally Induced Acute Low Back Pain

NCT03021278 | Completed

• 1 other identifier: 8/2016
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether experimentally induced acute low back pain might lead to alteration in lumbar tactile acuity measured in region affected by pain compared to pain-free side and pain-free controls.

Conditions

Acute Pain; Low Back Pain

Keywords

Tactile acuity; Chronic pain; Two-point discrimination; Point-to-point test; Two-point estimation; Body image

Outcome Measures

Primary Outcomes (1)

• Lumbar tactile acuity measured by two-point discrimination test (TPD).

  Mechanical callipers will be delicately applied to the pre-marked axis until the very first blanching of the skin. Testing will be commenced with 0 mm between the two calliper's tips, and then the distance between them will be gradually increased until participants will able to verbally report that two points had been touched instead of one. Subsequently, the descending sequence will be applied until the perception of the two points disappeared.

  Measured an average 3 minutes after manipulation (e.g. saline injection).

Secondary Outcomes (5)

• Pain intensity measured behaviourally on a Numerical Rating Scale (NRS).

  Pain intensity will be measured just after saline/sham injection and every 30 seconds after this time point up until 12 minutes.

• Distribution of pain measured by estimating the diameter of the circle representing area affected by pain. Greater circle (diameter) will refer to the greater distribution of pain (larger body surface affected).

  Pain distribution will be measured just after saline/sham injection and every 30 seconds after this time point up until 12 minutes.

• Fear of pain measured on a Numerical Rating Scale (NRS).

  Fear of pain measured only at baseline

• Lumbar tactile acuity measured by point-to-point test (PTP).

  PTP measured at baseline (1), an average 3 minutes after manipulation (2) (e.g. saline injection) and 12 minutes after manipulation (3)

• Lumbar tactile acuity measured by two-point estimation test (TPE)

  PTP measured at baseline (1), an average 3 minutes after manipulation (2) (e.g. saline injection) and 12 minutes after manipulation (3)

Other Outcomes (2)

• Fear of Pain Questionnaire (FPQ-III).

  Measured only at baseline

• Pain Catastrophizing Scale (PCS).

  Measured only at baseline

Study Arms (3)

Saline Injection

EXPERIMENTAL

In the saline injection group, low back pain will be induced via 1.0 ml hypertonic (5% NaCl).

Other: Saline injection

Sham Injection

EXPERIMENTAL

In the sham injection group, a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience.

Other: Sham injection

Control Group

NO INTERVENTION

The control group will not receive any kind of pain or pinprick sensation.

Interventions

Saline injection OTHER

In the saline injection group, low back pain will be induced via 1.0 ml hypertonic (5% NaCl) saline bolus injection which is a commonly used model of acute low back pain. Saline will be injected into the right (or left) lumbar longissimus muscle 50 mm lateral to the spinous process just above (5 mm) previously marked point. Injections will be performed by a physician under ultrasound imaging guidance to ensure that each single injection will be equally placed at a depth of 30 mm. The side for the pain induction will be randomised across subjects. The place of needle insertion and corresponding point on the opposite side of the body will be covered by placing a small piece of adhesive plaster.

Also known as: Experimental pain

Saline Injection

Sham injection OTHER

In the sham-injection group (placebo comparator), a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience. A pinprick sensation will be produced by a weighted stimulus applied perpendicularly to the skin just above without piercing the skin. A stimulus of 512 mN will be used to produce a pinprick sensation and activation of cutaneous nociceptors. Adhesive tapes covering stimulation points will also be provided.

Also known as: Sham pain

Sham Injection

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Only participants with similar mechanical detection threshold (MDT) on both sides of the spine will be included.

You may not qualify if:

• sex: female
• age \< 18 or \> 35 years
• laterality: left-handed
• current pain experience
• episodes of back pain lasting more than 24 hours within the previous one-month period
• history of chronic pain, i.e. pain lasting more than one-month
• comorbidities affecting the nervous system
• cardio-vascular diseases
• psychiatric illnesses
• any disease requiring systematic drug consumption.
• diagnosed hypersensitive reaction to saline solution

Sponsors & Collaborators

• The Jerzy Kukuczka Academy of Physical Education in Katowice: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

The Jerzy Kukuczka Academy of Physical Education

Katowice, 40-065, Poland

Location

Related Publications (5)

• Adamczyk W, Slugocka A, Saulicz O, Saulicz E. The point-to-point test: A new diagnostic tool for measuring lumbar tactile acuity? Inter and intra-examiner reliability study of pain-free subjects. Man Ther. 2016 Apr;22:220-6. doi: 10.1016/j.math.2015.12.012. Epub 2016 Jan 2.

  PMID: 26797175 BACKGROUND

• Catley MJ, O'Connell NE, Berryman C, Ayhan FF, Moseley GL. Is tactile acuity altered in people with chronic pain? a systematic review and meta-analysis. J Pain. 2014 Oct;15(10):985-1000. doi: 10.1016/j.jpain.2014.06.009. Epub 2014 Jun 28.

  PMID: 24983492 BACKGROUND

• Tsao H, Tucker KJ, Coppieters MW, Hodges PW. Experimentally induced low back pain from hypertonic saline injections into lumbar interspinous ligament and erector spinae muscle. Pain. 2010 Jul;150(1):167-172. doi: 10.1016/j.pain.2010.04.023. Epub 2010 May 26.

  PMID: 20510516 BACKGROUND

• Wand BM, Di Pietro F, George P, O'Connell NE. Tactile thresholds are preserved yet complex sensory function is impaired over the lumbar spine of chronic non-specific low back pain patients: a preliminary investigation. Physiotherapy. 2010 Dec;96(4):317-23. doi: 10.1016/j.physio.2010.02.005.

  PMID: 21056167 BACKGROUND

• Adamczyk WM, Saulicz O, Saulicz E, Luedtke K. Tactile acuity (dys)function in acute nociceptive low back pain: a double-blind experiment. Pain. 2018 Mar;159(3):427-436. doi: 10.1097/j.pain.0000000000001110.

  PMID: 29140929 DERIVED

Related Links

• Protocol of the meta-analysis on lumbar tactile acuity in patients with low back pain and healthy controls

MeSH Terms

Conditions

Acute Pain; Low Back Pain; Chronic Pain

Interventions

Sodium Chloride; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wacław M Adamczyk, Msc

  The Jerzy Kukuczka Academy of Physical Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)