| CTRI Number |
CTRI/2020/04/024509 [Registered on: 08/04/2020] Trial Registered Prospectively |
| Last Modified On: |
29/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The benefits of traction and upper limb nerve stretches on patients with radiating neck pain. |
|
Scientific Title of Study
|
Efficacy of Mechanical Traction and Upper Limb Tension Test in Patients with Cervical Radiculopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shabnam Joshi |
| Designation |
Assistant Professor GJUST Hisar |
| Affiliation |
Guru Jambheswar University of Science and Technology, Hisar |
| Address |
Department of Physiotherapy, Guru Jambheswar University of Science and Technology, Hisar, Haryana
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alka Pawalia |
| Designation |
Assistant Professor GJUST Hisar |
| Affiliation |
Guru Jambheswar University of Science and Technology, Hisar |
| Address |
Department of Physiotherapy, Guru Jambheswar University of Science and Technology, Hisar, Haryana
Hisar
HARYANA
125001
India |
| Phone |
9468349944 |
| Fax |
|
| Email |
alkapawalia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alka Pawalia |
| Designation |
Assistant Professor GJUST Hisar |
| Affiliation |
Guru Jambheswar University of Science and Technology, Hisar |
| Address |
Department of Physiotherapy, Guru Jambheswar University of Science and Technology, Hisar, Haryana
HARYANA
125001
India |
| Phone |
9468349944 |
| Fax |
|
| Email |
alkapawalia@gmail.com |
|
|
Source of Monetary or Material Support
|
| kalpana
MPT student
Department of Physiotherapy
Guru Jambheswar University of Science and Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Department of Physiotherapy Guru Jmbheswar University of Science and Technology Hisar Haryana |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kalpana Saroha |
Department of Physiotherapy |
Room No. 4 and 5 OPD of Department of Physiotherapy Guru Jambheswar University of Science and Technology,Hisar Haryana
Hisar
HARYANA |
7494828720
kalsaroha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, (2) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mechanical Traction |
Mechanical traction will be applied in supine position by manually adjusted mechanical traction equipment with 10 sec pull and 5sec rest for 10 min in a single session.Traction force will be equal to 10-15 % of body weight of each subject and calculated prior to intervention. |
| Comparator Agent |
Upper limb tension tests |
Median Nerve: Glenohumeral abduction, wrist extension,
supination, glenohumeral lateral rotation, elbow extension, neck lateral
bending to opposite side.
Radial Nerve: Glenohumeral depression, elbow extension, whole arm internal rotation, wrist flexion Ulnar Nerve: Wrist extension, forearm pronation elbow flexion,
glenohumeral lateral rotation, glenohumeral depression, shoulder abduction |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Both males and females with Cervical
Radiculopathy.
2.Positive Spurling test
3.Positive cervical distraction test |
|
| ExclusionCriteria |
| Details |
1.Subjects with cervical or thoracic surgery
2. Subjects with Rheumatoid Arthritis/OA
3. Subjects with history of trauma
4. Neck pain without radiculopathy
5. Subjects with neurological disorders
6. Subject with mental retardation
7. Patients without informed consent will be
excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index
Patient Specific Functional Scale
|
Pre reading 0 week
post reading 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale |
Pre reading 0 week
Post reading 4 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical radiculopathy is a common neuromusculoskeletal disorder causing pain
and disability. Pain perceived as arising in the arm caused by the irritation of
cervical spinal nerves or its roots is considered as radicular pain and termed as
radiculopathy, and 1 out of 1000 individuals suffer from cervical radiculopathy.
Cervical disk herniation and osteophyte are the main causes of cervical
radiculopathy. Cervical disk herniation usually causes the inflammation
compressing the nerve root which may result in radicular symptoms in the
ipsilateral extremity. Symptoms may vary according to the affected nerve root,
sensory, motor, and autonomic branches of the peripheral nerve. Patients with
cervical radiculopathy mostly seek treatment for neck pain, numbness, tingling
sensation, reduced grip strength, and overall weakness on the upper extremity
muscles. In the advanced disease, cervical muscles, which particularly contribute
to the mechanical stability of the cervical region at a rate of 80% is
affected. Cervical radiculopathy (CR) is an important subgroup of neck disorders.
Although less prevalent than mechanical neck pain, CR leads to more severe pain
and disability. Recently, neck stabilization exercises have gained popularity among therapeutic
exercises, although studies frequently included patients with mechanical neck
pain Cervical traction combined with exercise therapy has the additional
effects in reducing pain, and function, while managing neck pain conservatively.
There are studies which shows that the combined effect of intermittent
mechanical traction and neural mobilization are effective in cervical
radiculopathy. But there is no study which evaluate the effectiveness of
intermittent cervical traction over ULTT (upper limb traction tests). Hence, the
purpose of our study is to determine the efficacy of mechanical traction and ULTT on Pain, ROM, Disability.
|