| CTRI Number |
CTRI/2018/09/015659 [Registered on: 07/09/2018] Trial Registered Prospectively |
| Last Modified On: |
27/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Transcutaneous Electrical Nerve Stimulation (TENS) Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
new thrapy (TENS) for shoulder pain |
|
Scientific Title of Study
|
Effect of Transcutaneous Electrical Nerve Stimulation therapy on pain and functional disability level among patients with Rotator Cuff Disease:A Randomized Control Trial. |
| Trial Acronym |
TENS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PUSHPA RANI |
| Designation |
M.Sc. Nursing student |
| Affiliation |
AIIMS, Rishikesh, Uttarakhand |
| Address |
Room no. 1, 3RD floor, colllege of nursing, AIIMS, Rishikesh, Uttarakhand.
Room no. 1, 3rd floor, college of nursing, AIIMS, Rishikesh, Uttarakhand.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9266686770 |
| Fax |
|
| Email |
gahlawat.pushpa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasantha Kalyani |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh, Uttarakhand |
| Address |
Room no. 1, 3rd floor, college of nursing,AIIMS, Rishikesh, Uttarakhand.
Room no. 1, 3rd floor, college of nursing,AIIMS, Rishikesh, Uttarakhand.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9266686770 |
| Fax |
|
| Email |
vasantharaj2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PUSHPA RANI |
| Designation |
M.Sc. Nursing student |
| Affiliation |
AIIMS, Rishikesh, Uttarakhand |
| Address |
Room no. 1, 3rd floor, college of nursing,AIIMS, Rishikesh, Uttarakhand.
Room no. 1, 3rd floor, college of nursing, AIIMS, Rishikesh, Uttarakhand.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9266686770 |
| Fax |
|
| Email |
gahlawat.pushpa@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
pushpa rani |
| Address |
Room no. 1, 3rd floor, college of nursing,AIIMS, Rishikesh, Uttarakhand. |
| Type of Sponsor |
Other [] |
|
|
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 |
| pushpa rani |
AIIMS, Rishikesh |
orthopedics OPD, room no- 111, ground floor,
Dehradun
UTTARANCHAL |
09266686770
gahlawat.pushpa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M754||Impingement syndrome of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional therapy |
conventional therapy of treating rotator cuff disease include use of pain killers and ROM exercises. |
| Intervention |
TENS Therapy |
transcutaneous electrical nerve stimulation therapy is used for pain management that works on principal of pain gate theory. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to accept Transcutaneous Electrical Nerve Stimulation therapy.
2. Available for five consecutive days.
|
|
| ExclusionCriteria |
| Details |
1. Patients with age less than eighteen years and greater than sixty-five years.
2. Those who are contraindicated for Transcutaneous electrical nerve stimulation therapy.
3. Those who are already diagnosed with other orthopaedic problems
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain and functional disability level
|
after five days of transcutaneous electrical nerve stimulation therapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2018 |
| Date of Study Completion (India) |
01/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/01/2019 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Effect of transcutaneous electrical nerve stimulation therapy on pain and functional disability among patients with rotator cuff disease. Objectives of study is to assess the effectiveness of tens therapy over the conventional therapy. SPADI Scale will be used to assess pain and functional disability. |