Rheumatoid ArthritisNCT02110940
The Effect of Neurodynamic Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.
A study testing Neurodynamic mobilization exercise and Conservative Physiotherapy in people with Rheumatoid Arthritis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This clinical trial is the first study to apply neurodynamic mobilization, a nervous system specific therapeutic exercise, on patients with rheumatoid arthritis(RA). Objective of the study is to find out the effect of neurodynamic mobilization for joint inflammation in patients with RA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Neurodynamic mobilization exercise and Conservative Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2015to Aug 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria was considered as patients with rheumatoid arthritis; presence of inflammatory condition on the joints on upper and / or lower limbs; Rheumatoid Arthritis Pain Scale (RAPS) at least 10 points during activities of daily living; and adults (> 18 years of age) in either gender.
Who cannot join
- The exclusion criteria are: acute joint pain, physiotherapy or joint injections in the previous 3 months; change in corticosteroids in the previous month; and change in disease-modifying antirheumatic drugs in the previous 3 months; subjects with poor balance or significant pain which neurodynamic mobilization is unable to perform.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Chi ngai Lo, Master, +852 2766 6752, christ.lo@polyu.edu.hk
Chi ngai Lo, Master
About this study
Official title: The Effect of Neural Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.
This clinical trial is the first study to apply neurodynamic mobilization, a nervous system specific therapeutic exercise, on patients with rheumatoid arthritis(RA). Objective of the study is to find out the effect of neurodynamic mobilization for joint inflammation in patients with RA.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by generalized joints inflammation. With increasing investigation on the pathology, the treatment focus on the conditions shifted from a musculoskeletal point of view to a systemic approach. The awareness of holistic treatment was also increased.
Latest studies have found out the neurogenic inflammatory mechanism played an important role in the inflammatory process of RA, the pathological changes of neural tissues in RA were also noted.
This clinical trial is the first study to apply neurodynamic mobilization, a nervous system specific therapeutic exercise, on patients with RA. Objective of the study is to find out the effect of neurodynamic mobilization for joint inflammation in patients with RA.
Population Adults who are diagnosed with Rheumatoid Arthritis.
Intervention Neurodynamic Exercise
Comparison Standard conservative physiotherapy protocol
Outcome Rheumatoid Arthritis Pain Scale (RAPS) C-reactive protein (CRP) test
- Conditions
- Rheumatoid Arthritis
- Being tested
- Neurodynamic mobilization exercise, Conservative Physiotherapy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamic mobilization exerciseOther
The mobilization exercise is conducted with 10 repetitions for each action, the action is hold for 5 seconds when subjects had the stretch feeling. The series of exercise is told to perform 2 sets a day, daily practice.
Subjects' conditions will be reviewed at the end of 4th and 8th week. An exercise log book will be provided for each subject to record down the compliance of the exercise.
Conservative PhysiotherapyOther
The control group is assigned to received conventional treatment in the physiotherapy department with the standard rehabilitation protocol consisted of electrotherapy for pain relief, strengthening exercise to increase the strength of the thigh
| Study group | Role | What they receive |
|---|---|---|
| Conservative Physiotherapy | Active comparator | Subjects will be referred to the physiotherapy department to receive conventional physiotherapy treatment. Receives: Other: Conservative Physiotherapy |
| Neurodynamic mobilization exercise | Experimental | The experimental group will be given three neurodynamic mobilization exercises which focus more on lower limbs and the major innervating cutaneous nerves - saphenous nerve, sciatica nerve and femoral nerve.
Subjects will be instructed to practice everyday, each action repeat for 10 times. Receives: Other: Neurodynamic mobilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid Arthritis Pain Scale (RAPS)
Rheumatoid Arthritis Pain Scale (RAPS) will be used to rate the severity of the pain in subjects with RA; before, between and after the experimental period. The questionnaire consists of 24 items with a scale from 0-6 to quantify the severity of the Rheumatoid Arthritis
The test will be conducted in the baseline, at 4th week, and the end of the investigation at 8th week.
Measured: 8 weeks
Secondary outcomes (1)
C-reactive protein (CRP) test
C-reactive protein (CRP) is one of the most widely used measurements to indicate the severity of inflammation in rheumatoid arthritis. The choice of CRP is due to its cost effectiveness, reliability and reproducibility.
The test will be coducted by nurses, a 3cc blood sample will be taken from the subject and sent to the laboratory to investigate the C-reactive protein level. The test will be conducted in the baseline, at 4th week, and the end of the investigation at 8th week.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LO CHI NGAI, The Hong Kong Polytechnic University
- Investigators
- Chi Ngai Lo, Master, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110940
- Sponsor's protocol ID
- HSEARS20140401001
- Status last verified
- Feb 2016
- First submitted
- 8 Apr 2014
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neural Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT02110940
- Acronym / sponsor ID
- HSEARS20140401001
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 10 Apr 2014 (estimated)
- 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.
This clinical trial is the first study to apply neurodynamic mobilization, a nervous system specific therapeutic exercise, on patients with rheumatoid arthritis(RA). Objective of the study is to find out the effect of neurodynamic mobilization for joint inflammation in patients with RA.
Detailed description
Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by generalized joints inflammation. With increasing investigation on the pathology, the treatment focus on the conditions shifted from a musculoskeletal point of view to a systemic approach. The awareness of holistic treatment was also increased.
Latest studies have found out the neurogenic inflammatory mechanism played an important role in the inflammatory process of RA, the pathological changes of neural tissues in RA were also noted.
This clinical trial is the first study to apply neurodynamic mobilization, a nervous system specific therapeutic exercise, on patients with RA. Objective of the study is to find out the effect of neurodynamic mobilization for joint inflammation in patients with RA.
Population Adults who are diagnosed with Rheumatoid Arthritis.
Intervention Neurodynamic Exercise
Comparison Standard conservative physiotherapy protocol
Outcome Rheumatoid Arthritis Pain Scale (RAPS) C-reactive protein (CRP) test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Physiotherapy | Active comparator | Other: Conservative PhysiotherapySubjects will be referred to the physiotherapy department to receive conventional physiotherapy treatment. |
| Neurodynamic mobilization exercise | Experimental | Other: Neurodynamic mobilization exerciseThe experimental group will be given three neurodynamic mobilization exercises which focus more on lower limbs and the major innervating cutaneous nerves - saphenous nerve, sciatica nerve and femoral nerve. Subjects will be instructed to practice everyday, each action repeat for 10 times. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria was considered as patients with rheumatoid arthritis; presence of inflammatory condition on the joints on upper and / or lower limbs; Rheumatoid Arthritis Pain Scale (RAPS) at least 10 points during activities of daily living; and adults (> 18 years of age) in either gender.
Key exclusion criteria (1 listed)
- The exclusion criteria are: acute joint pain, physiotherapy or joint injections in the previous 3 months; change in corticosteroids in the previous month; and change in disease-modifying antirheumatic drugs in the previous 3 months; subjects with poor balance or significant pain which neurodynamic mobilization is unable to perform.
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 |
|---|---|---|
| Neurodynamic mobilization exerciseThe mobilization exercise is conducted with 10 repetitions for each action, the action is hold for 5 seconds when subjects had the stretch feeling. The series of exercise is told to perform 2 sets a day, daily practice. Subjects' conditions will be reviewed at the end of 4th and 8th week. An exercise log book will be provided for each subject to record down the compliance of the exercise. | Other | Neurodynamic mobilization exercise |
| Conservative PhysiotherapyThe control group is assigned to received conventional treatment in the physiotherapy department with the standard rehabilitation protocol consisted of electrotherapy for pain relief, strengthening exercise to increase the strength of the thigh | Other | Conservative Physiotherapy |
Primary outcome
Rheumatoid Arthritis Pain Scale (RAPS)
Time frame: 8 weeks
Rheumatoid Arthritis Pain Scale (RAPS) will be used to rate the severity of the pain in subjects with RA; before, between and after the experimental period. The questionnaire consists of 24 items with a scale from 0-6 to quantify the severity of the Rheumatoid Arthritis The test will be conducted in the baseline, at 4th week, and the end of the investigation at 8th week.
1 secondary outcome
C-reactive protein (CRP) test
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- 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.
Chi Ngai Lo, Master principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodynamic mobilization exercise and Conservative Physiotherapy in people with Rheumatoid Arthritis, 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 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 25 Feb 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi ngai Lo, Master (+852 2766 6752, christ.lo@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rheumatoid Arthritis Pain Scale (RAPS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.