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Reliability and Validity of Outcome Measures for Phantom Limb Pain

The Reliability and Validity of Outcome Measures for People Who Have Phantom Limb Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03588793
Enrollment
40
Registered
2018-07-17
Start date
2018-12-10
Completion date
2020-03-13
Last updated
2021-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phantom Limb Pain

Brief 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).

Interventions

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

Sponsors

Teesside University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age: ≥ 18 years At least six months post amputation (date of surgery) The amputation must be above wrist/ankle. Are currently experiencing PLP which has persisted for at least 3 months or more They rate their PLP as ≥3 on a 0-10 scale on at least 2 days in the preceding week Concomitant medications;

Exclusion criteria

* Participating in any research trial of any intervention hypothesised to affect PLP. Currently under-going active prosthetic rehabilitation e.g. walking training sessions or upper limb rehabilitation sessions. Any current non-prescribed substance dependency An inability to understand and follow basic instructions - both the two-point discrimination test and left/right limb judgement task requires the participant to follow basic/simple instructions. Any person, otherwise eligible, who commences any treatment for PLP (physical or pharmacological, prescribed or non-prescribed) will be withdrawn from the study.

Design outcomes

Primary

MeasureTime frameDescription
Statistical analysis of change in Visual Analogue Scale (VAS) for pain scoresAdministered on 2 separate occasions, 7-14 days apartIntra-rater reliability analysis

Secondary

MeasureTime frameDescription
Statistical analysis of change in EQ-5D-L scoresAdministered on 2 separate occasions, 7-14 days apartHealth related Quality of Life questionnaire. Intra-rater reliability analysis
Statistical analysis of change in Short Form McGill Pain Questionnaire 2 (SF-MPQ-2) scoresAdministered on 2 separate occasions, 7-14 days apartIntra-rater reliability analysis
Statistical analysis of change in Trinity Amputation and Prosthetic Evaluation Score - Revised (TAPES-R) - Amended version to include phantom limb pain and demographics questionsAdministered on 2 separate occasions, 7-14 days apartIntra-rater reliability

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026