Peripheral NeuropathyNCT05379140
Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV
A study testing Three Weekly Therapeutic Chinese Massage Sessions in people with Peripheral Neuropathy, run by University of Houston Downtown at 1 site in United States.
Trial summary
Background: Peripheral neuropathy (PN) occurs in half of the people with human immunodeficiency virus (PHIV). Currently, there is no Food and Drug Administration-approved treatment for HIV-related PN. Only half of PHIV who take medications report a significant reduction in pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Three Weekly Therapeutic Chinese Massage Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 10 Nov 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of HIV and peripheral neuropathy have self-reported PN-related pain in lower extremity are not taking any kind of medications to alleviate PN symptoms age at least 18 years old not pregnant or lactating
Who cannot join
- have received any kind of massage in the past three months Can not give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Houston-Downtown
Houston, Texas, 77002
About this study
Official title: Using Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With Human Immunodeficiency Virus: A Randomized Control Trial Pilot Study.
Background: Peripheral neuropathy (PN) occurs in half of the people with human immunodeficiency virus (PHIV). Currently, there is no Food and Drug Administration-approved treatment for HIV-related PN. Only half of PHIV who take medications report a significant reduction in pain. Therapeutic Chinese Massage, structured palpations or movements of soft tissues of the body, is a promising non-harmful, and non-costly intervention that can potentially alleviate or even treat PN but relevant research is limited.
Method: Investigators conducted a single centered, two-arm, single-blinded randomized controlled trial pilot study to examine if a series of three weekly 25-minute therapeutic Chinese massage sessions by a therapist of therapeutic Chinese massage, compared with placebo massage, could reduce PN-related pain and improve lower extremity functioning in PHIV. Twenty PHIV were recruited from the AIDS Foundation Houston, Inc in Texas. Pain, lower extremity functioning, and health-related quality of life were assessed for both groups prior to and post-massage.
- Conditions
- Peripheral Neuropathy
- Being tested
- Three Weekly Therapeutic Chinese Massage Sessions, Three Weekly Placebo Massage Sessions
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three Weekly Therapeutic Chinese Massage SessionsBehavioural
Participants in the therapeutic Chinese massage group received three weekly 25-minute therapeutic Chinese massage sessions. The intervention included acupressure to points along the distal lower extremity acupuncture points of the Gall Bladder Channel (GB 40 and then 34). Further Chinese Massage incorporates kneading, rolling, movement of the ankle, rotating, pulling, and scrubbing to the lower extremity.
Three Weekly Placebo Massage SessionsBehavioural
The placebo massage group received three weekly 25-minute placebo massage that included gentle rubbing to the foot and toes without point stimulation or other techniques of Chinese Massage. The control group had the opportunity to receive the treatment after the study was completed.
| Study group | Role | What they receive |
|---|---|---|
| The Therapeutic Chinese Massage Group | Experimental | Participants in the therapeutic Chinese massage group received three weekly 25-minute therapeutic Chinese massage sessions. The intervention included acupressure to points along the distal lower extremity acupuncture points of the Gall Bladder Channel (GB 40 and then 34). Further Chinese Massage incorporates kneading, rolling, movement of the ankle, rotating, pulling, and scrubbing to the lower extremity. Receives: Behavioral: Three Weekly Therapeutic Chinese Massage Sessions |
| The Placebo Massage Group | Placebo comparator | The placebo massage group received three weekly 25-minute placebo massage that included gentle rubbing to the foot and toes without point stimulation or other techniques of Chinese Massage. The control group had the opportunity to receive the treatment after the study was completed. Receives: Behavioral: Three Weekly Placebo Massage Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of this study design
recruitment and completion rates, patient safety, and treatment adherence and compliance
Measured: through study completion, an average of one year
Secondary outcomes (3)
Change in Peripheral neuropathy related pain at the third visit
It will be measured by the Numeric Pain Scale
Measured: Through study completion, an average of one year
Change in health related quality of life at the third visit
It will be measured by the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)
Measured: Through study completion, an average of one year
Change in lower extremity functioning at the third visit
It will be measured by the Lower Extremity Functioning Scale
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start10 Sep 2021
- Primary completion10 Aug 2022 (estimated)
- Study completion10 Nov 2022 (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 Peripheral NeuropathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
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
- NCT05379140
- Sponsor's protocol ID
- CPHS #44-21
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ge S, Dune L, Liu M, Fu G, Ma H, Hu J, Lin X, Li J. Feasibility of therapeutic Chinese massage (tui na) for peripheral neuropathy among people with human immunodeficiency virus: findings of a pilot randomized controlled trial. Front Neurol. 2023 Dec 1;14:1148150. doi: 10.3389/fneur.2023.1148150. eCollection 2023.
PubMed 38107641
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With Human Immunodeficiency Virus: A Randomized Control Trial Pilot Study.
- ClinicalTrials.gov ID
- NCT05379140
- Acronym / sponsor ID
- CPHS #44-21
- Conditions
- Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Houston DowntownUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Aug 2022 (estimated)
- Study completion
- 10 Nov 2022 (estimated)
- First posted
- 18 May 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.
Background: Peripheral neuropathy (PN) occurs in half of the people with human immunodeficiency virus (PHIV). Currently, there is no Food and Drug Administration-approved treatment for HIV-related PN. Only half of PHIV who take medications report a significant reduction in pain. Therapeutic Chinese Massage, structured palpations or movements of soft tissues of the body, is a promising non-harmful, and non-costly intervention that can potentially alleviate or even treat PN but relevant research is limited.
Method: Investigators conducted a single centered, two-arm, single-blinded randomized controlled trial pilot study to examine if a series of three weekly 25-minute therapeutic Chinese massage sessions by a therapist of therapeutic Chinese massage, compared with placebo massage, could reduce PN-related pain and improve lower extremity functioning in PHIV. Twenty PHIV were recruited from the AIDS Foundation Houston, Inc in Texas. Pain, lower extremity functioning, and health-related quality of life were assessed for both groups prior to and post-massage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Therapeutic Chinese Massage Group | Experimental | Behavioral: Three Weekly Therapeutic Chinese Massage SessionsParticipants in the therapeutic Chinese massage group received three weekly 25-minute therapeutic Chinese massage sessions. The intervention included acupressure to points along the distal lower extremity acupuncture points of the Gall Bladder Channel (GB 40 and then 34). Further Chinese Massage incorporates kneading, rolling, movement of the ankle, rotating, pulling, and scrubbing to the lower extremity. |
| The Placebo Massage Group | Placebo comparator | Behavioral: Three Weekly Placebo Massage SessionsThe placebo massage group received three weekly 25-minute placebo massage that included gentle rubbing to the foot and toes without point stimulation or other techniques of Chinese Massage. The control group had the opportunity to receive the treatment after the study was completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of HIV and peripheral neuropathy have self-reported PN-related pain in lower extremity are not taking any kind of medications to alleviate PN symptoms age at least 18 years old not pregnant or lactating
Key exclusion criteria (1 listed)
- have received any kind of massage in the past three months Can not give informed consent
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 |
|---|---|---|
| Three Weekly Therapeutic Chinese Massage SessionsParticipants in the therapeutic Chinese massage group received three weekly 25-minute therapeutic Chinese massage sessions. The intervention included acupressure to points along the distal lower extremity acupuncture points of the Gall Bladder Channel (GB 40 and then 34). Further Chinese Massage incorporates kneading, rolling, movement of the ankle, rotating, pulling, and scrubbing to the lower extremity. | Behavioural | The Therapeutic Chinese Massage Group |
| Three Weekly Placebo Massage SessionsThe placebo massage group received three weekly 25-minute placebo massage that included gentle rubbing to the foot and toes without point stimulation or other techniques of Chinese Massage. The control group had the opportunity to receive the treatment after the study was completed. | Behavioural | The Placebo Massage Group |
Primary outcome
Feasibility of this study design
Time frame: through study completion, an average of one year
recruitment and completion rates, patient safety, and treatment adherence and compliance
3 secondary outcomes
Change in Peripheral neuropathy related pain at the third visit
Time frame: Through study completion, an average of one year
Change in health related quality of life at the third visit
Time frame: Through study completion, an average of one year
Change in lower extremity functioning at the third visit
Time frame: Through study completion, an average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 38107641Ge S, Dune L, Liu M, Fu G, Ma H, Hu J, Lin X, Li J. Feasibility of therapeutic Chinese massage (tui na) for peripheral neuropathy among people with human immunodeficiency virus: findings of a pilot randomized controlled trial. Front Neurol. 2023 Dec 1;14:1148150. doi: 10.3389/fneur.2023.1148150. 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three Weekly Therapeutic Chinese Massage Sessions in people with Peripheral Neuropathy, run by University of Houston Downtown at 1 site in United States.
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 1 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Feasibility of this study design (time frame: through study completion, an average of one year). 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 NCT05379140, 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 18 May 2022.