Clinical trial NCT03588793: Reliability and Validity of Outcome Measures for Phantom Limb Pain
Official title: The Reliability and Validity of Outcome Measures for People Who Have Phantom Limb Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phantom Limb Pain
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Amputees

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).


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.

Primary outcomes:
measure: Statistical analysis of change in Visual Analogue Scale (VAS) for pain scores
timeFrame: Administered on 2 separate occasions, 7-14 days apart
Secondary outcomes:
measure: Statistical analysis of change in EQ-5D-L scores
timeFrame: Administered on 2 separate occasions, 7-14 days apart
measure: Statistical analysis of change in Short Form McGill Pain Questionnaire 2 (SF-MPQ-2) scores
timeFrame: Administered on 2 separate occasions, 7-14 days apart
measure: Statistical analysis of change in Trinity Amputation and Prosthetic Evaluation Score - Revised (TAPES-R) - Amended version to include phantom limb pain and demographics questions
timeFrame: Administered on 2 separate occasions, 7-14 days apart
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University School of Health & Social Care
Study officials:
References: