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

Pain Clinical Trial

Official title:

A Pilot Study to Assess the Efficacy of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00301444
• Other study ID #: DCI P05-A008
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2006
• Last updated: June 13, 2007
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: April 2007
• Source: Walter Reed Army Medical Center
• Contact: Jack W Tsao, MD
• Phone: 301-295-3643
• Email: jtsao[@]usuhs.mil
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

A total of forty-eight (48) subjects with be enrolled - twenty-four (24) with any unilateral lower limb amputation and twenty-four (24) with any unilateral upper limb amputation. Subjects will be randomized for assignment into three treatment conditions: eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use mental visualization of foot or hand movements, eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use an open mirror- box to visualize the reflected image of their intact foot or hand, and eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use a closed mirror- box (unable to visualize a reflected image). Subjects will use their assigned therapy for 20 minutes daily. Subjects using the closed mirror-box or mental visualization treatments will be switched to mirror therapy if they have not significantly improved following 4 weeks. The subjects for this study will be recruited from the Walter Reed Army Medical Center Amputee clinic. Up to sixty (60) subjects will be recruited and screened according to the inclusion and exclusion criteria since we expect that some may not qualify or drop-out sooner than the scheduled 4-month completion time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation
• Pain
• Phantom Limb

Intervention

Device:
• mirror-box treatment

Behavioral:
• Mental visualization

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (11)

Carlen PL, Wall PD, Nadvorna H, Steinbach T. Phantom limbs and related phenomena in recent traumatic amputations. Neurology. 1978 Mar;28(3):211-7. — View Citation

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

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. — View Citation

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. — View Citation

Katz J, Melzack R. Pain 'memories' in phantom limbs: review and clinical observations. Pain. 1990 Dec;43(3):319-36. Review. — View Citation

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. — View Citation

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-7. — View Citation

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. — View Citation

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):217-26. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant decrease in the level of phantom limb pain at 4 weeks.
Secondary	Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.