NCT03991689

Brief Summary

Objective: to verify the effect of solution-focused group therapy (SFBT) on pain management as well as physiological, psychological and social adaptation in patients with spinal cord injury. Setting: for matters of convenience, the samples were collected at medical and rehabilitation centers in Taiwan. Twenty-six patients with spinal cord injuries and neuropathic pain were invited to join the four pain management groups. Method: In the case of patients with spinal cord injury affected by neuropathic pain, a solution-focused pain management group therapy was conducted once a week for 6 weeks, 90 minutes each time; fear avoidance theory and acceptance and commitment therapy was used for pain management, using solution-focus group counseling strategies to guide group members to achieve pain management goals by accepting pain and establishing goals.The group effectiveness was assessed before and after the group intervention in terms of pain intensity (0-10 numeric rating scale), brief pain inventory-pain inference, chronic pain self-efficacy scale, pain fear (0-10 numeric rating scale), depression (patient health questionnaire-9), demoralization (demoralization scale), post-traumatic growth inventory and life quality (WHOQOL-BREF). Then we analyzed the correlation between the difference values of the variables before and after the test in order to understand the clinical application of the pain management group therapy for patients with spinal cord injury.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

June 9, 2019

Last Update Submit

June 18, 2019

Conditions

Keywords

spinal cord injurypain managementpain intensitypain self-efficacysolution-focused group therapy

Outcome Measures

Primary Outcomes (7)

  • The pain intensity and pain fear scale

    The pain intensity and pain fear scale is based on the Numeric Rating Scale, asking participants "the intensity of pain in your body now" and "the degree of fear towards the future caused by your physical pain", from a minimum of 0 to a maximum of 10.

    6 weeks

  • Brief Pain Inventory-Pain inference

    Participants are asked to answer the extent to which pain interferes with daily life, mood, relationships with others, sleep, breathing, cough, mobility, and enjoyment of life over the past 24 hours, with a score of 0 representing no interference to 10 points representing complete interference. The total score ranges from 0 to 70, and the higher the score, the greater the degree of interference from pain.

    6 weeks

  • Pain management self-efficacy subscale and symptom response self-efficacy subscale within Chronic Pain Self-Efficacy Scale (CPSS)

    Since most of the patients with spinal cord injury were injured in the whole body or in the lower part of their body, the self-efficacy of their physical functions could not be revealed. Therefore, the 9 questions regarding the body function self-efficacy subscale were removed and revised into 13 questions regarding the pain self-efficacy. Participants used 0 to 10 points to indicate their degree of confidence in management and response to the situation described; 0 points indicate complete uncertainty, 10 points indicate 10% confidence, and the total score ranged from 0 to 130 points.

    6 weeks

  • The depression scale uses Patient Health Questionnaires-9

    participants are asked to answer the frequency of symptoms described in the topic over the past two weeks, namely 0 points in case there were no symptoms, several days (1 point), more than one week (2 points) and almost every day (3 points) score. The total score ranges from 0 to 27 points. The higher the score, the more serious the depression.

    6 weeks

  • Demoralization scale - Mandarin Version (DS-M)

    DS-M includes loss of meaning, dysphoria, disheartenment, sense of failure, helplessness, and other items for total of 24 questions, with a score ranging from 0 to 4, namely from completely disagree to completely agree. The total score ranges from 0 to 96 points. The higher the score, the higher the degree of demoralization.

    6 weeks

  • Post-traumatic growth inventory (PTGI)

    PTGI assesses an individual's possible positive psychological changes after major stress events, including increasing the relation with others, opening up to new possibilities, increasing personal strength, appreciation of life, and spiritual change. The scale has a total of 21 questions, 0-5 points indicating a scale from no change to a very large degree of change. The total score ranges from 0 to 105 points. Spinal cord injury is mostly caused by accidents. So for a part of those with post-traumatic stress disorder (PTSD), it is estimated that post-traumatic growth can provide information about the psychological recovery of people with spinal cord injury.

    6 weeks

  • The quality of life adopts Taiwan's concise version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF-TW)

    It is made up of the 26 questions of WHOQOL-BREF , plus 2 questions related to Taiwan, for a total of 28 questions. The individual score ranges from 1 to 5. The total score ranges from 0 to 140. The higher the score, the better the quality of life.

    6 weeks

Study Arms (1)

the six weeks solution-focused pain management groups

EXPERIMENTAL
Behavioral: solution-focused group therapy

Interventions

Participants began a 90-minute solution-focused pain management group, which lasted for six weeks, and after the group ended, the questionnaire post-test was carried out, and a total of 26 participants thus completed their group journey. The group effect was evaluated by the difference between the scores of the questionnaires before and after the group.

the six weeks solution-focused pain management groups

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with spinal cord injury as being in compliance with the Taiwan National Health Insurance's definition

You may not qualify if:

  • Psychiatric disabilities
  • Intellectual disabilities
  • Unconscious patients
  • Patients in critical condition
  • Bedridden patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AgnosiaSpinal Cord InjuriesPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2019

First Posted

June 19, 2019

Study Start

April 29, 2014

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share