NCT02110940

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

April 8, 2014

Last Update Submit

February 23, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • C-reactive protein (CRP) test

    8 weeks

Study Arms (2)

Conservative Physiotherapy

ACTIVE COMPARATOR

Subjects will be referred to the physiotherapy department to receive conventional physiotherapy treatment.

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.

Other: Neurodynamic mobilization exercise

Interventions

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.

Neurodynamic mobilization exercise

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

Conservative Physiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Chi Ngai Lo, Master

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi ngai Lo, Master

CONTACT

Xia Guo, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 10, 2014

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations