Reliability and Validity of Outcome Measures for Phantom Limb Pain

NCT03588793 | Completed

• 1 other identifier: TU243418
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Intra-rater reliability analysis

  Administered on 2 separate occasions, 7-14 days apart

Secondary Outcomes (3)

• Statistical analysis of change in EQ-5D-L scores

  Administered on 2 separate occasions, 7-14 days apart

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

  Administered on 2 separate occasions, 7-14 days apart

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

  Administered on 2 separate occasions, 7-14 days apart

Interventions

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

Also known as: Implicit Motor Imagery Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Amputees

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teesside University: lead

Study Sites (1)

Teesside University School of Health & Social Care

Middlesbrough, United Kingdom

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 17, 2018
• Study Start: December 10, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

GB (1)