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Reliability and Validity of Outcome Measures for Phantom Limb Pain

NCT03588793 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-04-08

No results posted yet for this study

Summary

Phantom limb pain (PLP) is experienced by 60-80% of all people who have had an amputation. This persistent pain condition can impact on independence, activities of daily living and overall quality of life.

While there is some research into PLP there is no consensus on appropriate outcome measures and there is (to our knowledge) neither guideline nor literature evidence on the reliability and validity of outcomes measures for this patient group. Such measures are vital to the robust evaluation of any interventions and/or monitoring progression.

The aim of the proposed study is to assess the reliability and validity of four self-report questionnaires (Visual Analog Scale (VAS) for pain, Short Form McGill Pain Questionnaire 2 (SFMPQ-2), Trinity Amputation and Prosthetic Evaluation Scale (TAPES), a health-related quality of life measure (EQ-5D-L), a pain diary, a left/right limb judgement task (Implicit Motor Imagery Testing - IMIT) and the two-point discrimination (TPD)test.

The data will be collated and statistically analysed to assess how stable each of the measures are over time (intra session reliability) and how each measure co-relates with the others (validity).

Conditions

  • Phantom Limb Pain

Interventions

OTHER

Two Point Discrimination

Validity of mechanism in phantom limb pain i.e. cortical reorganisation to be tested using comparison of data from interventions above

Sponsors & Collaborators

  • Teesside University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2020-03-13
Completion
2020-03-13

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03588793 on ClinicalTrials.gov