Lower Extremity Splinting to Manage Pain and Sleep Disturbances Associated With HIV/AIDS Related Peripheral Neuropathy

NCT01419314 | Completed Results

• 1 other identifier: 16196
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

WHAT IS THE PURPOSE OF THIS STUDY? The investigators want to know if wearing a pair of splints at night works to bring the pain down and help you sleep better (in people living with HIV/AIDS related neuropathy). HOW MANY PEOPLE WILL PARTICIPATE? About 58 to 88 people will take part in this study at the Harris County Hospital District (HCHD). WHAT WILL HAPPEN DURING THIS STUDY? As a participant, you will be assigned to one of two treatment groups. In one group, you will be asked to wear leg splints at night and the other you will wear the liners of the splints only. You will be asked to answer questions about how well you sleep, how long you sleep, and about your discomfort at the legs. The researcher will be there to help, but the investigators want you to answer the questions on your own if you can. You will be asked to reach forwards standing next to a wall and to walk for 6 minutes after that. The tests will de done in random order. The sessions will be done at the beginning, at week three and week six. You should finish all of the testing and questionnaires in an hour or less, for a total of three hours over six weeks in the investigators clinic. You will receive instructions on how to use the splints with liners or the liners alone at home. You will be asked to wear them at night only for the next 6 weeks. Finally, the principal investigator will contact you weekly by phone, to discuss issues of comfort and your ability to adhere to the instructions provided.

Conditions

HIV; AIDS; Peripheral Neuropathy; Pain; Sleep

Keywords

Physical Therapy; Splint; Sleep; Pain; 6 min walk; forward reach; Function

Outcome Measures

Primary Outcomes (4)

• Pain Scores at Week 3

  A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.

  Week 3

• Pain Scores

  A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.

  Week 6

• Sleep Quality/Quantity Scores (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.

  week 3

• Sleep Quality/Quantity Scores (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.

  week 6

Secondary Outcomes (4)

• Function-Reach

  week 3

• Function-Reach

  week 6

• Function-Walking Distance

  week 3

• Function-Walking Distance

  week 6

Study Arms (2)

Splinting application

EXPERIMENTAL

Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.

Device: Splinting application to the lower extremities

Splint liner application

PLACEBO COMPARATOR

The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.

Device: Splint liner application

Interventions

Splinting application to the lower extremities DEVICE

Walkabout™ splints (Don Joy Orthopedics, Vista, CA, USA) will used in the splinting treatment. The Walkabout splint is a one-piece injection molded walking boot fitted with a rocker bottom allowing for ambulation. The participants will be fitted and instructed to wear the bilateral LE splints to sleep for the duration of the study (6 weeks).

Also known as: Walkabout splint

Splinting application

Splint liner application DEVICE

The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study (6 weeks).

Also known as: Walkabout liner

Splint liner application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult PLWA 18 and older, with a clinical diagnosis of symptomatic bilateral LE PN will be invited to participate.
• The participants will be on a stable pain and HIV/AIDS management regimen without foreseeable alterations or changes to said pharmacological regimen, which may include pain and or sleep medications.
• The participants will be community dwelling individuals, able to walk at or above a modified independence level with or without the need of an assistive device to ambulate, such as a cane or walker.
• Eligible participants will report at least one of the following clinical symptoms: paresthesia, dysesthesia, and report night cramps in the LE

You may not qualify if:

• Participants will be excluded if they have a clinical diagnosis of any of the following: significant cardiovascular or pulmonary disease (specifically, myocardial infarction within the past six months, angina, or dyspnea at rest), paraplegia, hemiplegia, other major neurological dysfunction, diabetes, absent pedal pulse during examination, sleep apnea, or are pregnant.
• Additionally, patients unable to read English, patients with changes to their pharmacological management during the study and or using any mechanical devices to assist in normalizing sleep will be excluded from this study.

Sponsors & Collaborators

• Texas Woman's University: lead
• Harris County Hospital District: collaborator
• DJO Incorporated: collaborator

Study Sites (1)

Thomas Street Health Center-HCHD

Houston, Texas, 77009, United States

Location

Related Publications (1)

• Sandoval R, Runft B, Roddey T. Pilot study: does lower extremity night splinting assist in the management of painful peripheral neuropathy in the HIV/AIDS population? J Int Assoc Physicians AIDS Care (Chic). 2010 Nov-Dec;9(6):368-81. doi: 10.1177/1545109710373828. Epub 2010 Nov 12.

  PMID: 21075912 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Peripheral Nervous System Diseases; Pain

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The contrast between the splinting group and liner group was statistically underpowered. The data was collected and analyzed by the primary investigator. The clinical diagnosis of peripheral neuropathy was not confirmed with EMG or punch skin biopsy.

Results Point of Contact

• Title: Roberto Sandoval PT
• Organization: Texas Woman's University

rsandoval@mail.twu.edu

713-859-9351

Study Officials

• Robert Sandoval, MS, PT

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 3, 2013
• Results First Posted: January 3, 2013

Record last verified: 2012-12

Locations

US (1)