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Completed

NCT Number: NCT03588793

Reliability and Validity of Outcome Measures for Phantom Limb Pain

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).

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Key information

Conditions

Phantom Limb Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teesside University School of Health & Social Care

Middlesbrough, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Two Point Discrimination

Other

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

Other names: Implicit Motor Imagery Testing

Primary outcomes

  1. Statistical analysis of change in Visual Analogue Scale (VAS) for pain scores

    Time frame: Administered on 2 separate occasions, 7-14 days apart

    Intra-rater reliability analysis

Secondary outcomes

  1. Statistical analysis of change in EQ-5D-L scores

    Time frame: Administered on 2 separate occasions, 7-14 days apart

    Health related Quality of Life questionnaire. Intra-rater reliability analysis

  2. Statistical analysis of change in Short Form McGill Pain Questionnaire 2 (SF-MPQ-2) scores

    Time frame: Administered on 2 separate occasions, 7-14 days apart

    Intra-rater reliability analysis

  3. Statistical analysis of change in Trinity Amputation and Prosthetic Evaluation Score - Revised (TAPES-R) - Amended version to include phantom limb pain and demographics questions

    Time frame: Administered on 2 separate occasions, 7-14 days apart

    Intra-rater reliability

Sponsors and collaborators

Lead sponsor

Teesside University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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