A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain

NCT00301444 | Unknown

• 1 other identifier: DCI P05-A008
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers propose to conduct a pilot study on the efficacy of mirror-box and mental visualization treatments on phantom limb pain. The trial will last for 4 months and during the first month, data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, average intensity of pain, and worst intensity of pain. In addition, the rapidity of pain relief, the length of therapy needed to sustain long-lasting pain relief, and whether use of these two treatment methods during rehabilitation can provide sustained and/or permanent pain relief will be determined. Cognitive testing will also be performed to determine the effect of limb amputation on cognition and mood with results being compared to an on-going study of similar effects in patients with chronic (\> 3 months) limb amputation. The inclusion of subjects with phantom limb pain in upper extremity amputations has recently been approved.

Conditions

Amputation; Phantom Limb; Pain

Keywords

phantom limb pain; limb amputation

Outcome Measures

Primary Outcomes (1)

• Significant decrease in the level of phantom limb pain at 4 weeks.

Secondary Outcomes (1)

• Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.

Interventions

mirror-box treatment DEVICE

Mental visualization BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18 to 70 years of age, active duty military, beneficiary, or retiree.
• Written informed consent and written authorization for use or release of health and research study information.
• Any single unilateral upper or lower limb amputation with the presence of phantom limb pain.
• No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
• Normal neurological examination.
• Degree of pain evaluated by VAS scoring a minimum of 3 cm at time of screening for entry into the study, with a minimum of three episodes per week.
• Ability to follow study instructions and likely to complete all required visits.

You may not qualify if:

• Age less than 18 or greater than 70.
• Bilateral upper or lower limb amputation.
• Presence of traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record.
• Known uncontrolled systemic disease- known cancer not in remission, known on-going infection, lupus, kidney disease requiring dialysis, any other systemic disease which might affect ability to participate in this study to its conclusion
• Concurrent participation in another investigational drug or device study for phantom limb pain or participation in the 30 days immediately prior to study enrollment.
• Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
• Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study.
• Subjects with lack of effort as determined by the neurologist or physiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) first in order to exclude those with blatant exaggeration or malingering.

Sponsors & Collaborators

• United States Department of Defense: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

RECRUITING

Related Publications (12)

• Carlen PL, Wall PD, Nadvorna H, Steinbach T. Phantom limbs and related phenomena in recent traumatic amputations. Neurology. 1978 Mar;28(3):211-7. doi: 10.1212/wnl.28.3.211.

  PMID: 564474 BACKGROUND

• Sherman RA, Sherman CJ, Parker L. Chronic phantom and stump pain among American veterans: results of a survey. Pain. 1984 Jan;18(1):83-95. doi: 10.1016/0304-3959(84)90128-3.

  PMID: 6709380 BACKGROUND

• Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0.

  PMID: 7777055 BACKGROUND

• MacLachlan M, McDonald D, Waloch J. Mirror treatment of lower limb phantom pain: a case study. Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):901-4. doi: 10.1080/09638280410001708913.

  PMID: 15497919 BACKGROUND

• Jackson PL, Lafleur MF, Malouin F, Richards CL, Doyon J. Functional cerebral reorganization following motor sequence learning through mental practice with motor imagery. Neuroimage. 2003 Oct;20(2):1171-80. doi: 10.1016/S1053-8119(03)00369-0.

  PMID: 14568486 BACKGROUND

• Ramachandran VS, Altschuler EL, Stone L, Al-Aboudi M, Schwartz E, Siva N. Can mirrors alleviate visual hemineglect? Med Hypotheses. 1999 Apr;52(4):303-5. doi: 10.1054/mehy.1997.0651.

  PMID: 10465667 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

  PMID: 3670870 BACKGROUND

• Ochipa C, Rapcsak SZ, Maher LM, Rothi LJ, Bowers D, Heilman KM. Selective deficit of praxis imagery in ideomotor apraxia. Neurology. 1997 Aug;49(2):474-80. doi: 10.1212/wnl.49.2.474.

  PMID: 9270580 BACKGROUND

• Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.

  PMID: 8008411 BACKGROUND

• Katz J, Melzack R. Pain 'memories' in phantom limbs: review and clinical observations. Pain. 1990 Dec;43(3):319-336. doi: 10.1016/0304-3959(90)90029-D.

  PMID: 2293143 BACKGROUND

• Finn SB, Perry BN, Clasing JE, Walters LS, Jarzombek SL, Curran S, Rouhanian M, Keszler MS, Hussey-Andersen LK, Weeks SR, Pasquina PF, Tsao JW. A Randomized, Controlled Trial of Mirror Therapy for Upper Extremity Phantom Limb Pain in Male Amputees. Front Neurol. 2017 Jul 7;8:267. doi: 10.3389/fneur.2017.00267. eCollection 2017.

  PMID: 28736545 DERIVED

MeSH Terms

Conditions

Phantom Limb; Pain

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

Study Officials

• Jack W Tsao, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack W Tsao, MD

CONTACT

301-295-3643; jtsao@usuhs.mil

Richard L Witt, PA-C

CONTACT

202-782-8705; richard.witt@amedd.army.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 10, 2006
• Study Start: March 1, 2006
• Study Completion: June 1, 2008
• Last Updated: June 14, 2007

Record last verified: 2007-04

Locations

US (1)