The Effect of Neurodynamic Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Neurodynamic mobilization exercise
Conservative Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conservative Physiotherapy
Neurodynamic mobilization exercise
Arm Description
Subjects will be referred to the physiotherapy department to receive conventional physiotherapy treatment.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02110940
First Posted
April 8, 2014
Last Updated
February 23, 2016
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT02110940
Brief Title
The Effect of Neurodynamic Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.
Official Title
The Effect of Neural Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conservative Physiotherapy
Arm Type
Active Comparator
Arm Description
Subjects will be referred to the physiotherapy department to receive conventional physiotherapy treatment.
Arm Title
Neurodynamic mobilization exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurodynamic mobilization exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conservative Physiotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Rheumatoid Arthritis Pain Scale (RAPS)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
C-reactive protein (CRP) test
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi ngai Lo, Master
Phone
+852 2766 6752
Email
christ.lo@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Xia Guo, MD, PhD
Phone
+852 2766 6720
Email
Xia.Guo@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Ngai Lo, Master
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi ngai Lo, Master
Phone
+852 2766 6752
Email
christ.lo@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Chi ngai Lo, Master
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Neurodynamic Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.
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