Reliability and Validity of Outcome Measures for Phantom Limb Pain

NCT ID: NCT03588793

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-10
• Study Completion Date: 2020-03-13

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).

Conditions

Phantom Limb Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Two Point Discrimination

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

Intervention Type: OTHER

Other Intervention Names

Implicit Motor Imagery Testing

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teesside University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Graham

PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Teesside University School of Health & Social Care

Middlesbrough, , United Kingdom

Countries

United Kingdom

Other Identifiers

TU243418

Identifier Type: -

Identifier Source: org_study_id