The Effect of Neurodynamic Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis Clinical Trial

Official title:

The Effect of Neural Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02110940
• Other study ID #: HSEARS20140401001
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2014
• Last updated: February 23, 2016
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: The Hong Kong Polytechnic University
• Contact: Chi ngai Lo, Master
• Phone: +852 2766 6752
• Email: christ.lo[@]polyu.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Neurodynamic mobilization exercise
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 Physiotherapy
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

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Secondary	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.	8 weeks	Yes