|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03021278 |
|
Date of registration:
|
09/01/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Tactile Acuity in Experimentally Induced Acute Low Back Pain
|
|
Scientific title:
|
Lumbar Tactile Acuity in Experimentally Induced Acute Low Back Pain |
|
Date of first enrolment:
|
January 2017 |
|
Target sample size:
|
57 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03021278 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Poland
| | | | | | | |
|
Contacts
|
|
Name:
|
Waclaw M Adamczyk, Msc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Jerzy Kukuczka Academy of Physical Education |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Only participants with similar mechanical detection threshold (MDT) on both sides of
the spine will be included.
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Pain
|
|
Low Back Pain
|
|
Intervention(s)
|
|
Other: Saline injection
|
|
Other: Sham injection
|
|
Primary Outcome(s)
|
|
Lumbar tactile acuity measured by two-point discrimination test (TPD).
[Time Frame: Measured an average 3 minutes after manipulation (e.g. saline injection).]
|
|
Secondary Outcome(s)
|
|
Lumbar tactile acuity measured by two-point estimation test (TPE)
[Time Frame: PTP measured at baseline (1), an average 3 minutes after manipulation (2) (e.g. saline injection) and 12 minutes after manipulation (3)]
|
|
Pain intensity measured behaviourally on a Numerical Rating Scale (NRS).
[Time Frame: Pain intensity will be measured just after saline/sham injection and every 30 seconds after this time point up until 12 minutes.]
|
|
Lumbar tactile acuity measured by point-to-point test (PTP).
[Time Frame: PTP measured at baseline (1), an average 3 minutes after manipulation (2) (e.g. saline injection) and 12 minutes after manipulation (3)]
|
|
Fear of pain measured on a Numerical Rating Scale (NRS).
[Time Frame: Fear of pain measured only at baseline]
|
|
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).
[Time Frame: Pain distribution will be measured just after saline/sham injection and every 30 seconds after this time point up until 12 minutes.]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|