Reliability and Validity of Outcome Measures for Phantom Limb Pain

Phantom Limb Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588793
• Other study ID #: TU243418
• Status: Completed
• Start date: December 10, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: April 2021
• Source: Teesside University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

Other:
• Two Point Discrimination
Validity of mechanism in phantom limb pain i.e. cortical reorganisation to be tested using comparison of data from interventions above

Locations

Country	Name	City	State
United Kingdom	Teesside University School of Health & Social Care	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Teesside University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Statistical analysis of change in EQ-5D-L scores	Health related Quality of Life questionnaire. Intra-rater reliability analysis	Administered on 2 separate occasions, 7-14 days apart
Secondary	Statistical analysis of change in Short Form McGill Pain Questionnaire 2 (SF-MPQ-2) scores	Intra-rater reliability analysis	Administered on 2 separate occasions, 7-14 days apart
Secondary	Statistical analysis of change in Trinity Amputation and Prosthetic Evaluation Score - Revised (TAPES-R) - Amended version to include phantom limb pain and demographics questions	Intra-rater reliability	Administered on 2 separate occasions, 7-14 days apart