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Trial record 23 of 2723 for:    Rheumatoid Arthritis

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

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ClinicalTrials.gov Identifier: NCT02110940
Recruitment Status : Unknown
Verified February 2016 by LO CHI NGAI, The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
First Posted : April 10, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
LO CHI NGAI, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Neurodynamic mobilization exercise Other: Conservative Physiotherapy Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Neural Mobilization Exercise on Lower Limb Pain in Patients With Rheumatoid Arthritis.
Study Start Date : August 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conservative Physiotherapy
Subjects will be referred to the physiotherapy department to receive conventional physiotherapy treatment.
Other: 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

Experimental: Neurodynamic mobilization exercise

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.

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.





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. C-reactive protein (CRP) test [ Time Frame: 8 weeks ]

    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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110940


Contacts
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Contact: Chi ngai Lo, Master +852 2766 6752 christ.lo@polyu.edu.hk
Contact: Xia Guo, MD, PhD +852 2766 6720 Xia.Guo@polyu.edu.hk

Locations
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Hong Kong
The Hong Kong Polytechnic University Recruiting
Hong Kong, Hong Kong
Contact: Chi ngai Lo, Master    +852 2766 6752    christ.lo@polyu.edu.hk   
Principal Investigator: Chi ngai Lo, Master         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Chi Ngai Lo, Master

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Responsible Party: LO CHI NGAI, Mr., The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02110940     History of Changes
Other Study ID Numbers: HSEARS20140401001
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases