Chronic Pain After Amputation | NCT00006427

Studies
Chronic Pain After Amputation

NCT00006427

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Status

Completed

Last Update Posted

Sep 26, 2016Estimated

Enrollment

125

Phase

Phase 4

Conditions

Amputation, Traumatic
Pain
Postoperative Pain

Interventions

Amitriptyline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P01HD033988	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1996

Primary Completion Date

Jul 2001Actual

Completion Date

Not provided

First Submitted Date

Nov 1, 2000

First Submission Date that Met QC Criteria

Nov 1, 2000

First Posted Date

Nov 2, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2016

Last Update Posted Date

Sep 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

Collaborators

Not provided

Description Module

Brief Summary

This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation

Detailed Description

This double-masked placebo controlled trial will randomize patients (n=125) who are 6 months or more after amputation and have a 3 or more month history of pain to a daily dose of amitriptyline or a placebo for 6 weeks. Patients will receive a complete functional neurological examination by one of the study physicians or nurses masked to their treatment assignment. Study participants will also be interviewed by telephone to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain, at the beginning and end of the six-week trial and four months later.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125

Name	Type	Description	Arm Group Labels	Other Names
Amitriptyline	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Amputation six months ago or longer
Pain for 3 months or longer

Exclusion Criteria:

History of cardiovascular disease, seizures, or glaucoma
Currently taking antidepressant medications
Currently hyperthyroid or taking thyroid medication
Currently pregnant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence Robinson, MD, Professor	University of Washington, Department of Rehabilitation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington, Department of Rehabilitation Medicine		Seattle	Washington	98195	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8321759	Background	Davis RW. Successful treatment for phantom pain. Orthopedics. 1993 Jun;16(6):691-5. doi: 10.3928/0147-7447-19930601-10.
1535121	Background	Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992 May;49(2):205-219. doi: 10.1016/0304-3959(92)90144-Z.

ID	Term
D000673	Amputation, Traumatic
D010146	Pain
D010149	Pain, Postoperative
D059350	Chronic Pain

ID	Term
D014947	Wounds and Injuries
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003986	Dibenzocycloheptenes
D001567	Benzocycloheptenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic