HivNCT05596123
Tui na for Peripheral Neuropathy Among People With HIV
A study testing Therapeutic Chinese foot massage in people with Hiv, run by University of Houston Downtown.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Therapeutic Chinese foot massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have confirmed HIV diagnosis
- self-report PN-related symptoms in their lower extremity, such as sharp, jabbing, throbbing, or burning pain, numbness, decreased sensation to pinprick, prickling or tingling feeling, lack of coordination and falling muscle weakness, and extreme sensitivity to touch
- are not taking any medications, including pain medicine, to alleviate PN
- age 18 years and older
- can communicate with researchers in English or Mandarin Chinese
- are not pregnant or lactating
- are not concurrently enrolled in other clinical trials.
Who cannot join
- 1) People who have received any non-pharmacological interventions, including massage to treat their PN symptoms in the past six months
About this study
Official title: Therapeutic Chinese Foot Massage for Peripheral Neuropathy Symptoms Among People With Human Immunodeficiency Virus: A a Randomized Controlled Trial
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.
Read the detailed description
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).
- Conditions
- Hiv
- Being tested
- Therapeutic Chinese foot massage, Placebo massage
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Chinese foot massageBehavioural
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.
Placebo massageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Therapeutic Chinese foot massage |
| The Placebo Massage Group | Placebo comparator | Six weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group. Receives: Behavioral: Placebo massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity pain
The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain.
Measured: 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.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston Downtown
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Ge, University of Houston Downtown
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596123
- Sponsor's protocol ID
- UHDowntown
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36908633
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Chinese Foot Massage for Peripheral Neuropathy Symptoms Among People With Human Immunodeficiency Virus: A a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05596123
- Acronym / sponsor ID
- UHDowntown
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Houston DowntownUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| therapeutic Chinese foot massage (TCFM) | Experimental | Behavioral: Therapeutic Chinese foot massageA 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 | Behavioral: Placebo massageSix weekly 25-minute TCFM sessions will be delivered to participants in the TCFM group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- have confirmed HIV diagnosis
- self-report PN-related symptoms in their lower extremity, such as sharp, jabbing, throbbing, or burning pain, numbness, decreased sensation to pinprick, prickling or tingling feeling, lack of coordination and falling muscle weakness, and extreme sensitivity to touch
- are not taking any medications, including pain medicine, to alleviate PN
- age 18 years and older
- can communicate with researchers in English or Mandarin Chinese
Key exclusion criteria (1 listed)
- 1) People who have received any non-pharmacological interventions, including massage to treat their PN symptoms in the past six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Chinese foot massageParticipants 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. | Behavioural | therapeutic Chinese foot massage (TCFM) |
| Placebo massageThe 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. | Behavioural | The Placebo Massage Group |
Primary outcome
Lower extremity pain
Time frame: at 6 months
The numeric pain scale has a score range between 0 and 10. A higher score indicates more pain.
Lower extremity functioning
Time frame: at 6 months
The lower extremity functioning scale has a score range between 0 and 80. A higher score indicates better functioning.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Derived from this study: PubMed 36908633Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Chinese foot massage in people with Hiv, run by University of Houston Downtown.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity pain (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05596123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.