Spinal Cord InjuriesNCT05558657
Effect of Acupressure on Constipation in Community-dwelling Spinal Cord Injury Patients: a Randomized Controlled Trial
A study testing Home-based, acupressure combined with nursing education and Home-based, manual light touch of the abdomen combined with nursing education in people with Spinal Cord Injuries and Traditional Chinese Medicine, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Spinal cord injury is a multi-sensory, motor and autonomic dysfunction, caused by various types of acute and chronic central nervous system injuries. And it will affect patient's ability to live normally and return to society. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Traditional Chinese Medicine
- What is being tested?
- Home-based, acupressure combined with nursing education and Home-based, manual light touch of the abdomen combined with nursing education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2023to 30 Sep 2024
- 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
- being Hong Kong residents between the ages of 18 or older,
- having an SCI diagnosis for over 6 months and living in the community,
- demonstrating the willingness and ability to learn and engage in acupressure (or having a caregiver to assist if self-operating is not feasible),
- experiencing difficulties with defecation or having concerns related to defecation.
Who cannot join
- currently undergoing other TCM treatments or receiving interventions related to defecation or bowel functions,
- being unable to attend the training sessions due to personal reasons,
- having a history of gastrointestinal organic disease,
- having severe metabolic diseases, cardiovascular, cerebrovascular, or mental illnesses
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The Hong Kong Polytechnic Unviersity
Hong Kong
About this study
Official title: Effect of Home-based Acupressure on Constipation in People with Spinal Cord Injury: a Study Protocol for a Randomized Controlled Trial with a Mixed-method Approach
Spinal cord injury is a multi-sensory, motor and autonomic dysfunction, caused by various types of acute and chronic central nervous system injuries. And it will affect patient's ability to live normally and return to society. Due to lack of physical activity and psychological and environmental factors, the feces remain in the intestine for too long, and there will be excessive water absorption and lead to dryness and difficulty in excretion and it will be constipation. Chinese medicine, acupuncture and acupressure are the treatments of constipation in Traditional Chinese Medicine. Acupressure is a non- invasive intervention which is easy to learn and apply. We have carried out a number of studies on spinal cord injury rehabilitation support and acupressure to solve chronic problems such as constipation and anxiety. And this study aims to investigate the effects of acupressure combined with nursing intervention on constipation and quality of life in community-dwelling spinal cord injury patients.
Read the detailed description
This study will use an open-label, double-group, randomized controlled trial to compare the effect of the intervention group with the control group. Study participants will be recruited from the "Hong Kong Direction Association for the Handicapped, a non-governmental organization dedicated to serving severely disabled Hong Kong people such as SCI. The sociodemographic data, disease status and outcome indicators of the study subjects were measured before the intervention, after the intervention and one month after the intervention. Research assistants (RA1) were trained to evaluate data and data, blinded to group assignments.
We will have the focus group interviews (semi-structured) with participants after the the intervention (post-intervention). The interviews will be conducted online to further understand the benefits and limitations of the research intervention.
- Conditions
- Spinal Cord Injuries, Traditional Chinese Medicine
- Being tested
- Home-based, acupressure combined with nursing education, Home-based, manual light touch of the abdomen combined with nursing education
- Keywords
- Spinal cord injury, Acupressure, Community-dwelling, Traditional Chinese Medicine
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based, acupressure combined with nursing educationOther
The intervention group will focus on 11 acupoints on the abdomen (RN12, RN4, ST25), back (BL20, BL21, BL22, BL23, BL24, BL25), and limbs (LI4, ST36). The participants or their caregivers can perform acupressure 30 minutes after meals and twice a day. Participants can choose between two sets of acupressure: (1) Acupressure of the abdominal and back acupoints in a seated position, or (2) Acupressure of the abdominal and limb acupoints in a supine position. Each session lasts approximately 15 minutes.
Besides, the intervention group will also receive nursing education on the basis of receiving acupressure intervention including (1) dietary guidance: help patients to formulate a reasonable diet plan, (2) cultivate regular defecation habits, (3) understand appropriate defecation environments and postures, and (4) Moderate exercise to increase gastrointestinal motility.
Home-based, manual light touch of the abdomen combined with nursing educationOther
Control group or their caregivers will apply the manual light touch to the abdomen in any direction or body position at home. In keeping consistent with the intervention group, abdomen touching will also be administered twice daily for approximately 15 minutes each for 10 days. Participants will also receive nursing education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive home-based acupressure and nursing education. Receives: Other: Home-based, acupressure combined with nursing education |
| Control group: Home-based sham group , acupressure combined with nursing interventions | Active comparator | The control group will receive home-based, manual light touch of the abdomen combined with nursing education. Receives: Other: Home-based, manual light touch of the abdomen combined with nursing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of constipation at baseline
Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
Measured: The severity of constipation will be assessed at baseline assessment.
The severity of constipation at post-intervention
Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
Measured: The severity of constipation will be assessed after 10 days intervention.
The severity of constipation at one month follow-up
Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
Measured: The severity of constipation will be assessed after one month follow-up.
Secondary outcomes (9)
Quality of life at baseline
The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life.
Measured: Quality of life will be assessed at baseline assessment.
Quality of life at post-intervention
The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life.
Measured: Quality of life will be assessed after 10 days intervention.
Quality of life at one month follow-up
The Patient Assessment of Constipation Quality of Life Questionnaire will be used to measure the quality of life of Spinal cord injury participants. The scale investigates the quality of life of people in the past two weeks, using a 5-point Likert scale, assigning 0-4 points for various discomforts from "not at all" to "extremely". Each domain score and total score are the average scores of the domain items and all items, respectively. Higher scores indicate poorer quality of life.
Measured: Quality of life will be assessed after one month follow-up.
Psychosocial well-being at baseline
The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week.
Measured: Psychosocial well-being will be assessed at baseline assessment.
Psychosocial well-being at post-intervention
The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week.
Measured: Psychosocial well-being will be assessed after 10 days intervention.
Psychosocial well-being at one month follow-up
The Depression Anxiety Stress Scale (DASS) will be used to measure participants' psychosocial well-being. The scale investigates the negative emotional experience or the corresponding physiological response in the last week.
Measured: Psychosocial well-being will be assessed after one month follow-up
Bowel habit at baseline
Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week.
Measured: Bowel habit will be assessed at baseline assessment.
Bowel habit at post-intervention
Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week.
Measured: Bowel habit will be assessed after 10 days intervention.
Bowel habit at one month follow-up
Bowel habits will be assessed during each visit by recording the frequency of laxative and glycerine enema use, as well as the frequency and duration of defecation in the past week.
Measured: Bowel habit will be assessed after one month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Mar 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Model description
- We aim to have two study group, including the intervention group that receive acupressure combined with nursing interventions, and the control group that receive acupressure on sham acupoints combined with nursing interventions
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Li, Dr, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558657
- Sponsor's protocol ID
- P0035107
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2022
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
March, I.C.f.C.o.S.C.I.P.J.I., Global summary of spinal cord injury, incidence and economic impact. 2004.
Qiu J. China Spinal Cord Injury Network: changes from within. Lancet Neurol. 2009 Jul;8(7):606-7. doi: 10.1016/S1474-4422(09)70162-0. No abstract available.
PubMed 19539234Zhao JR, Chen W, Zhao N, Zhang H. Q, Zhu. B. Research Progress on Mechanism of Traditional Chinese Medicine in Treatment of Spinal Cord Injury, Chinese Archives of Traditional Chinese Medicine. (2020); 8:1-14.
Zhong C, Li YM. Overview of Chinese Medicine and Experimental Profiles on Spinal Cord Injury, Journal of Hunan University of Chinese Medicine. 2015; 35(10): 66-69.
Sun Y, Zhan D, Tan MS, Discuss treating the Spinal Cord injury from the dredge of the Governor Vessel Chinese Journal of Traditional Medical Traumatology & Orthopedics. 2018; (2): 64-66.
Sun Y. Study on the correlation between surgical treatment of atlantoaxial dislocation and nourishing qi and yang, Beijing University of Chinese Medicine. 2019.
Xu W, Hao M. Clinical study on abdominal Eight Diagrams Manipulation Maneuver combined with nursing intervention in the treatment of constipation in patients with spinal cord injury, China Health Industry. 2013; 10(26): 190-191.
Wong WK, Chien WT, Lee WM. Self-administered acupressure for treating adult psychiatric patients with constipation: a randomized controlled trial. Chin Med. 2015 Nov 3;10:32. doi: 10.1186/s13020-015-0064-7. eCollection 2015.
PubMed 26535053Liao CH, Xie ZL. Experience of traditional Chinese medicine nursing intervention on preventing constipation in bedridden patients with spinal cord injury experience, Chinese Community Doctors. 2012; 14(23): 299-300.
Su SY, Qian R, Wei SH. Clinical observation of acupoint sticking in the treatment of constipation due to spleen deficiency and qi stagnation, Nei Mongol Journal of Traditional Chinese Medicine. 2018; 37(6): 96-97.
Bengtsson M, Ohlsson B. Psychological well-being and symptoms in women with chronic constipation treated with sodium picosulphate. Gastroenterol Nurs. 2005 Jan-Feb;28(1):3-12. doi: 10.1097/00001610-200501000-00002.
PubMed 15738724De Giorgio R, Ruggeri E, Stanghellini V, Eusebi LH, Bazzoli F, Chiarioni G. Chronic constipation in the elderly: a primer for the gastroenterologist. BMC Gastroenterol. 2015 Oct 14;15:130. doi: 10.1186/s12876-015-0366-3.
PubMed 26467668Li HM, Gao JH. Clinical study of raw potato juice combined with abdominal Bagua massage in the treatment of spinal cord injury and constipation, Nei Mongol Journal of Traditional Chinese Medicine. 2014; 33(13): 37-38.
Zhang D, Xia ZW. Rome III criteria for functional constipation, Chinese Journal of Medicine. 2008; 43(12): 63-64.
Chang HC et al., Study on the effect of acupressure on constipation in nursing home residents, Journal of Yuanpei University. 2010; (17): 53-64.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home-based Acupressure on Constipation in People with Spinal Cord Injury: a Study Protocol for a Randomized Controlled Trial with a Mixed-method Approach
- ClinicalTrials.gov ID
- NCT05558657
- Acronym / sponsor ID
- P0035107
- Conditions
- Spinal Cord Injuries, Traditional Chinese Medicine
- Keywords
- Spinal cord injury, Acupressure, Community-dwelling, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 28 Sep 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.
Spinal cord injury is a multi-sensory, motor and autonomic dysfunction, caused by various types of acute and chronic central nervous system injuries. And it will affect patient's ability to live normally and return to society. Due to lack of physical activity and psychological and environmental factors, the feces remain in the intestine for too long, and there will be excessive water absorption and lead to dryness and difficulty in excretion and it will be constipation. Chinese medicine, acupuncture and acupressure are the treatments of constipation in Traditional Chinese Medicine. Acupressure is a non- invasive intervention which is easy to learn and apply. We have carried out a number of studies on spinal cord injury rehabilitation support and acupressure to solve chronic problems such as constipation and anxiety. And this study aims to investigate the effects of acupressure combined with nursing intervention on constipation and quality of life in community-dwelling spinal cord injury patients.
Detailed description
This study will use an open-label, double-group, randomized controlled trial to compare the effect of the intervention group with the control group. Study participants will be recruited from the "Hong Kong Direction Association for the Handicapped, a non-governmental organization dedicated to serving severely disabled Hong Kong people such as SCI. The sociodemographic data, disease status and outcome indicators of the study subjects were measured before the intervention, after the intervention and one month after the intervention. Research assistants (RA1) were trained to evaluate data and data, blinded to group assignments.
We will have the focus group interviews (semi-structured) with participants after the the intervention (post-intervention). The interviews will be conducted online to further understand the benefits and limitations of the research intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We aim to have two study group, including the intervention group that receive acupressure combined with nursing interventions, and the control group that receive acupressure on sham acupoints combined with nursing interventions
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Home-based, acupressure combined with nursing educationThe intervention group will receive home-based acupressure and nursing education. |
| Control group: Home-based sham group , acupressure combined with nursing interventions | Active comparator | Other: Home-based, manual light touch of the abdomen combined with nursing educationThe control group will receive home-based, manual light touch of the abdomen combined with nursing education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being Hong Kong residents between the ages of 18 or older,
- having an SCI diagnosis for over 6 months and living in the community,
- demonstrating the willingness and ability to learn and engage in acupressure (or having a caregiver to assist if self-operating is not feasible),
- experiencing difficulties with defecation or having concerns related to defecation.
Key exclusion criteria (4 listed)
- currently undergoing other TCM treatments or receiving interventions related to defecation or bowel functions,
- being unable to attend the training sessions due to personal reasons,
- having a history of gastrointestinal organic disease,
- having severe metabolic diseases, cardiovascular, cerebrovascular, or mental illnesses
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 |
|---|---|---|
| Home-based, acupressure combined with nursing educationThe intervention group will focus on 11 acupoints on the abdomen (RN12, RN4, ST25), back (BL20, BL21, BL22, BL23, BL24, BL25), and limbs (LI4, ST36). The participants or their caregivers can perform acupressure 30 minutes after meals and twice a day. Participants can choose between two sets of acupressure: (1) Acupressure of the abdominal and back acupoints in a seated position, or (2) Acupressure of the abdominal and limb acupoints in a supine position. Each session lasts approximately 15 minutes. Besides, the intervention group will also receive nursing education on the basis of receiving acupressure intervention including (1) dietary guidance: help patients to formulate a reasonable diet plan, (2) cultivate regular defecation habits, (3) understand appropriate defecation environments and postures, and (4) Moderate exercise to increase gastrointestinal motility. | Other | Intervention group |
| Home-based, manual light touch of the abdomen combined with nursing educationControl group or their caregivers will apply the manual light touch to the abdomen in any direction or body position at home. In keeping consistent with the intervention group, abdomen touching will also be administered twice daily for approximately 15 minutes each for 10 days. Participants will also receive nursing education. | Other | Control group: Home-based sham group , acupressure combined with nursing interventions |
Primary outcome
The severity of constipation at baseline
Time frame: The severity of constipation will be assessed at baseline assessment.
Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
The severity of constipation at post-intervention
Time frame: The severity of constipation will be assessed after 10 days intervention.
Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
The severity of constipation at one month follow-up
Time frame: The severity of constipation will be assessed after one month follow-up.
Constipation Assessment Scale (CAS) will be used to measure the severity of constipation of the Spinal cord injury participants, 0 indicated no problem, 1 indicated some problem, 2 indicated severe problem. High scores will indicated the more severe condition of constipation.
9 secondary outcomes
Quality of life at baseline
Time frame: Quality of life will be assessed at baseline assessment.
Quality of life at post-intervention
Time frame: Quality of life will be assessed after 10 days intervention.
Quality of life at one month follow-up
Time frame: Quality of life will be assessed after one month follow-up.
Psychosocial well-being at baseline
Time frame: Psychosocial well-being will be assessed at baseline assessment.
Psychosocial well-being at post-intervention
Time frame: Psychosocial well-being will be assessed after 10 days intervention.
Psychosocial well-being at one month follow-up
Time frame: Psychosocial well-being will be assessed after one month follow-up
Bowel habit at baseline
Time frame: Bowel habit will be assessed at baseline assessment.
Bowel habit at post-intervention
Time frame: Bowel habit will be assessed after 10 days intervention.
Bowel habit at one month follow-up
Time frame: Bowel habit will be assessed after one month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- BackgroundMarch, I.C.f.C.o.S.C.I.P.J.I., Global summary of spinal cord injury, incidence and economic impact. 2004.
- Background: PubMed 19539234Qiu J. China Spinal Cord Injury Network: changes from within. Lancet Neurol. 2009 Jul;8(7):606-7. doi: 10.1016/S1474-4422(09)70162-0. No abstract available.
- BackgroundZhao JR, Chen W, Zhao N, Zhang H. Q, Zhu. B. Research Progress on Mechanism of Traditional Chinese Medicine in Treatment of Spinal Cord Injury, Chinese Archives of Traditional Chinese Medicine. (2020); 8:1-14.
- BackgroundZhong C, Li YM. Overview of Chinese Medicine and Experimental Profiles on Spinal Cord Injury, Journal of Hunan University of Chinese Medicine. 2015; 35(10): 66-69.
- BackgroundSun Y, Zhan D, Tan MS, Discuss treating the Spinal Cord injury from the dredge of the Governor Vessel Chinese Journal of Traditional Medical Traumatology & Orthopedics. 2018; (2): 64-66.
- BackgroundSun Y. Study on the correlation between surgical treatment of atlantoaxial dislocation and nourishing qi and yang, Beijing University of Chinese Medicine. 2019.
- BackgroundXu W, Hao M. Clinical study on abdominal Eight Diagrams Manipulation Maneuver combined with nursing intervention in the treatment of constipation in patients with spinal cord injury, China Health Industry. 2013; 10(26): 190-191.
- Background: PubMed 26535053Wong WK, Chien WT, Lee WM. Self-administered acupressure for treating adult psychiatric patients with constipation: a randomized controlled trial. Chin Med. 2015 Nov 3;10:32. doi: 10.1186/s13020-015-0064-7. eCollection 2015.
- BackgroundLiao CH, Xie ZL. Experience of traditional Chinese medicine nursing intervention on preventing constipation in bedridden patients with spinal cord injury experience, Chinese Community Doctors. 2012; 14(23): 299-300.
- BackgroundSu SY, Qian R, Wei SH. Clinical observation of acupoint sticking in the treatment of constipation due to spleen deficiency and qi stagnation, Nei Mongol Journal of Traditional Chinese Medicine. 2018; 37(6): 96-97.
- Background: PubMed 15738724Bengtsson M, Ohlsson B. Psychological well-being and symptoms in women with chronic constipation treated with sodium picosulphate. Gastroenterol Nurs. 2005 Jan-Feb;28(1):3-12. doi: 10.1097/00001610-200501000-00002.
- Background: PubMed 26467668De Giorgio R, Ruggeri E, Stanghellini V, Eusebi LH, Bazzoli F, Chiarioni G. Chronic constipation in the elderly: a primer for the gastroenterologist. BMC Gastroenterol. 2015 Oct 14;15:130. doi: 10.1186/s12876-015-0366-3.
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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.
Yan Li, Dr principal investigator
School of Nursing, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based, acupressure combined with nursing education and Home-based, manual light touch of the abdomen combined with nursing education in people with Spinal Cord Injuries and Traditional Chinese Medicine, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Oct 2024. 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 Hong Kong. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The severity of constipation at baseline (time frame: The severity of constipation will be assessed at baseline assessment.). The study lists 3 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 NCT05558657, which also lists 36 linked publications.
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 10 Oct 2024.