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

NCT01705600 | Unknown

• 1 other identifier: 23210
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Sensitization; Low Back Pain; Pain Catastrophizing

Keywords

Central Sensitization; Low Back Pain; Pain; Pain Catastrophizing; Brence

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for Pain

  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.

  week 1,4,12, 26

Secondary Outcomes (1)

• Pain Catastrophizing Scale

  Weeks 1,4,12,26

Other Outcomes (1)

• Global Rating of Perceived Change

  At discharge (Avg. 4-6 weeks after enrollment)

Study Arms (1)

Pain Verbalization Repression Rules

EXPERIMENTAL

This group will wear a bracelet with a set of rules which will restrict ones verbalization of pain complaints

Behavioral: Pain Verbalization Repression Rules

Interventions

Pain Verbalization Repression Rules BEHAVIORAL

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.

Pain Verbalization Repression Rules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• a.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.

You may not qualify if:

• Any red-flags indicating the low back pain is caused by non-musculoskeletal pathology
• 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)
• 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)

Sponsors & Collaborators

• Keystone Rehabilitation Systems: lead

Study Sites (1)

Keystone Physical Therapy

Pittsburgh, Pennsylvania, 15017, United States

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph B Brence, DPT

  Physiotherapy Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: October 12, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

US (1)