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Verbalization in Patients With Non-specific Low Back Pain and Central Sensitization

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ClinicalTrials.gov Identifier: NCT01705600
Recruitment Status : Unknown
Verified October 2012 by Joseph Brence, Keystone Rehabilitation Systems.
Recruitment status was:  Active, not recruiting
First Posted : October 12, 2012
Last Update Posted : October 12, 2012
Sponsor:
Information provided by (Responsible Party):
Joseph Brence, Keystone Rehabilitation Systems

Brief Summary:

The primary goal of this study is to examine the effects of limiting complaints on pain and pain catastrophizing (PC) in individuals with low back pain (LBP) who are in a state of central sensitization (CS).

The study will be performed on individuals who have LBP and are in a state of CS. CS is classified as a type of pain which has the following dominant features: pain that is disproportionate to the nature or extent of injury/pathology; disproportionate, non-mechanical, unpredictable pattern of pain provocation in response to aggravating/easing factors; strong association with maladaptive psychological factors

; diffuse/non-anatomic areas of pain/tenderness to palpation. These criterion have been demonstrated to have discriminative validity for diagnosing CS.


Condition or disease Intervention/treatment Phase
Central Sensitization Low Back Pain Pain Catastrophizing Behavioral: Pain Verbalization Repression Rules Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Protocol for the Evaluation of the Effects of Limiting Verbal Complaints on Pain and Pain Catastrophizing in Individuals With LBP Who Are in a State of Central Sensitization
Study Start Date : September 2012
Estimated Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Pain Verbalization Repression Rules
This group will wear a bracelet with a set of rules which will restrict ones verbalization of pain complaints
Behavioral: Pain Verbalization Repression Rules
The involved subjects will be randomized to either a bracelet with receive verbal repression guidelines OR just a bracelet. They will receive typical physical therapy interventions for the treatment of low back pain (modalities, exercise, manual treatment) with the only change being the education of the one group to repress verblization of pain complaints. The bracelet is worn as a reminder of the rules given.




Primary Outcome Measures :
  1. Visual Analogue Scale for Pain [ Time Frame: week 1,4,12, 26 ]
    This is the visual analogue scale for pain which is routinely used in Physical Therapy practice. The multiple time frames are to assess a change in subjective pain values throughout the study.


Secondary Outcome Measures :
  1. Pain Catastrophizing Scale [ Time Frame: Weeks 1,4,12,26 ]
    This scale measures catastrophic thoughts often related to prolonged pain. The multiple time frames are to assess a change in subjective values throughout the study.


Other Outcome Measures:
  1. Global Rating of Perceived Change [ Time Frame: At discharge (Avg. 4-6 weeks after enrollment) ]
    This rates an individuals perceived change in recovery after physical therapy interventions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Individuals over the age of 18 who present to physical therapy with a clinical diagnosis of non-specific low back pain.

Their pain must also have the one of the following characteristics:

2a.the pain is disproportionate to the nature or extent of injury/pathology AND/OR 2b.the pain is disproportionate, non-mechanical, and unpredictable in response to aggravating/easing factors AND/OR 2c.the pain has a strong association with maladaptive psychological factors AND/OR 2d. the pain is diffuse/non-anatomic areas of pain/tenderness to palpation.

Exclusion Criteria:

  1. Any red-flags indicating the low back pain is caused by non-musculoskeletal pathology
  2. Pain whose origin could be better defined as noceptive (intermittent and sharp with movement or mechanical provocation; pain localized to the area of injury or dysfunction; clear, proportionate mechanical/anatomical nature to aggravating and easing factors; pain described as shooting, burning, sharp, electric-like; pain in association with other dysesthesias; night pain/disturbed sleep; antalgic postures/movement)
  3. Pain whose origin could better be defined as peripheral neuropathic (history of nerve injury, pathology or mechanical compromise; pain in a dermatomal or cutaneous distribution; pain/symptoms provocation with movement tests that move or compress neural tissue (ex. SLR)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705600


Locations
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United States, Pennsylvania
Keystone Physical Therapy
Pittsburgh, Pennsylvania, United States, 15017
Sponsors and Collaborators
Keystone Rehabilitation Systems
Investigators
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Principal Investigator: Joseph B Brence, DPT Physiotherapy Associates

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Responsible Party: Joseph Brence, Physical Therapist, Keystone Rehabilitation Systems
ClinicalTrials.gov Identifier: NCT01705600     History of Changes
Other Study ID Numbers: 23210
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012
Keywords provided by Joseph Brence, Keystone Rehabilitation Systems:
Central Sensitization
Low Back Pain
Pain
Pain Catastrophizing
Brence
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms