NCT02262234

Brief Summary

Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to treat. Many treatments reduce chronic pain only partially. As a result, many people with SCI must find ways of accomplishing daily activities even though they have pain. The purpose of this research study is to determine how well two different kinds of education programs reduce the extent to which chronic pain interferes with daily life and well-being.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

October 7, 2014

Last Update Submit

May 8, 2020

Conditions

Spinal Cord InjuryChronic Pain

Keywords

Spinal cord injuryChronic painEducation

Outcome Measures

Primary Outcomes (1)

  • Pain interference with activities

    The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS). The MPI-LIS is a 10-item self-report of extent of interference of pain with life activities and the enjoyment of life. The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.

    Week 10 versus baseline

Secondary Outcomes (3)

  • Pain intensity

    Week 10 versus baseline

  • Mental health and well-being

    Week 10 versus baseline

  • Pain attitudes

    Week 10 versus baseline

Study Arms (2)

Education Program Type 1

EXPERIMENTAL
Other: Education Program Type 1

Education Program Type 2

EXPERIMENTAL
Other: Education Program Type 2

Interventions

Education Program Type 1OTHER

The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.

Education Program Type 1
Education Program Type 2OTHER

The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.

Education Program Type 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury for at least one year
  • Chronic pain for at least three months that is moderate to severe (rated at or above 4/10 on a scale of 0 to 10 where 0 = "no pain" and 10 = "pain as bad as you can imagine")
  • Fluent in English
  • Not currently starting a new pain treatment or changing a previous pain treatment

You may not qualify if:

  • Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect my physical or mental functioning
  • Significant difficulties with learning or memory
  • Previous participation in a health and function education program specifically designed for people with chronic pain and SCI
  • Inability to understand English
  • Presence of other conditions not related to SCI that cause pain (such as fibromyalgia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesChronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeanne M Zanca, PhD, MPT

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 13, 2014

Study Start

September 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

US(1)