Incidence and Factors Affecting the Development and Outcome of Phantom Limb Pain (PLP) - A Single-centre Prospective Cohort Study.

NCT05005481 | Unknown DMC

• 1 other identifier: 2021/2456
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Phantom limb pain (PLP), defined as pain felt in the missing portion of the amputated limb following amputation, occurs in a significant percentage of patients who undergo limb amputation and it is among the most difficult chronic pain syndromes to treat. Its incidence has been reported to be around 70% though a local pilot study in 2013 reported the incidence to be 25%. The investigators aim to determine the actual incidence of PLP by conducting a single-centre prospective cohort study and identify risk factors associated with PLP. Subsequently, the investigators will use identified risk factors to develop and validate a risk prediction model for PLP after amputation surgery and design interventional studies aimed at reducing the development of PLP in high risk patients.

Conditions

Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of Phantom Limb Pain

  Phantom Limb Pain

  3 months

Interventions

NIL intervention OTHER

NIL intervention will be performed on patients.

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients listed for limb amputation surgery will be recruited in the ward

You may qualify if:

• Age 21-80 years old
• Provided consent for the study
• Types of amputation surgery included: Forefoot amputation, below knee amputation, above knee amputation

You may not qualify if:

• Cognitive impairment/ uncommunicative patients
• Existing psychiatric condition

Sponsors & Collaborators

• Singapore General Hospital: lead
• Diana Chan Xin Hui: collaborator
• Lin Xufeng: collaborator
• Yap Haoyun: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

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

Central Study Contacts

Zhen Wei LIM, M Med

CONTACT

+65 97807505; lim.zhen.wei@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: August 9, 2021
• Primary Completion: April 9, 2022
• Study Completion: June 30, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)