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Peripheral neuropathy (PN) is a common neurological complication in people with human immunodeficiency virus (PHIV) with no Food and Drug Administration-approved treatment. Medications commonly used to treat HIV-related PN are not effective and have many side effects. HIV-related PN symptoms may be alleviated or treated with therapeutic Chinese foot massage (TCFM), a non-invasive, relatively safe, non-pharmacological intervention.
This is a prospective, two-arm, double-blinded, randomized controlled trial. Aim: This trial aims to assess the effectiveness of TCFM on HIV-related PN in people with HIV (PHIV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapeutic Chinese foot massage (TCFM) | Experimental | A one-to-one ratio will be used to randomly assign participants to the TCFM group or the placebo massage group. |
|
| The Placebo Massage Group | Placebo Comparator | Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Chinese foot massage | Behavioral | Participants in the TCFM group will receive six weekly 25-minute TCFM sessions by a therapist. Each session will start with an assessment of the legs and toes of the affected extremity for broken skin and lesions, which the therapist will try to avoid. The participant will be positioned with support to their foot and legs, with the sole directed downward and the therapist directly in alignment with the soles of the foot. The therapist will sequentially perform the following four steps for each TCFM session. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower extremity pain | The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain. | at 6 months |
| Lower extremity functioning | The lower extremity functioning scale has a score range between 0 and 80. A higher score indicates better functioning. | at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
1) People who have received any non-pharmacological interventions, including massage to treat their PN symptoms in the past six months
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36908633 | Derived | Zhu X, Ge S, Dune L, Yang C, Tian C, Wang Y. Tui Na for painful peripheral neuropathy in people with human immunodeficiency virus: A randomized, double-blind, placebo-controlled trial protocol. Front Neurol. 2023 Feb 23;14:1113834. doi: 10.3389/fneur.2023.1113834. eCollection 2023. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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This is a prospective, two-arm, double-blinded, randomized controlled trial. A one-to-one ratio will be used to randomly assign participants to the TCFM group or the placebo massage group. Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group. Six weekly 25-minute sessions of placebo massage will be delivered to participants in the placebo massage group.
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Participants, the outcome assessors, and the statistician will be unaware of the group assignment.
|
| Placebo massage | Behavioral | The same therapist will give six weekly 25-minute placebo massage sessions to participants in the placebo massage group. These sessions will include assessing the affected extremity's legs and toes for lesions and broken skin in order to avoid them during the massage, as well as gentle foot and toe rubbing without any point stimulation or other TCFM techniques. |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |