| CTRI Number |
CTRI/2024/12/078114 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
High intensity LASER effect on post operative rotator cuff tear. |
|
Scientific Title of Study
|
Effect of High Intensity Laser on Pain Joint Range of Motion and Functional Ability of patients with Post Operative Rotator Cuff Tear. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mirza Nauman Baig |
| Designation |
PG Scholar |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health and Allied Sciences
Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8527787307 |
| Fax |
|
| Email |
mirzanaumanbaig786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health and Allied Sciences
Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health and Allied Sciences
Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University Noida Sector 125 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Mirza Nauman Baig |
| Address |
Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University Noida Sector 125 Uttar Pradesh India |
| Type of Sponsor |
Other [[Self]] |
|
|
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 |
| Dr Jasobanta Sethi |
Amity Institute of Health and Allied Sciences |
Department of Physiotherapy Amity Institute of Health and Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9988600462
jsethi@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy,Amity Institute of Health and Allied Sciences, Amity University, Noida, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High intensity LASER. |
High-IntensityLaserTherapy (HILT) is a non-invasive treatment modality that utilizes high-energy light to go deep into tissues, aiming to accelerate the healing process and improve post-surgical outcomes. High intensity laser therapeutic may provide rapid and effective pain relief which could enable patient to participate more effectively in the rehabilitation exercises. Hilt may help to reduce inflammation and promote tissue healing, with the result decreasing painfulness allows for a greater function range of motion and facilitate a faster recovery process. For this activity itself, as pain level reduce along with range of motion there tend to be better functional outcomes that boost strength and especially endurance long-term leading back into day-to-day activities. The experimental group will receive HILT sessions 3 times per week for 4 weeks with standard rehabilitation exercises. The HILT will be given at the wavelength of 1064 nm having power of 5.00 watts with frequency of 10 hertz and dosage of 750 joules per cm square for 5 minutes. The exercises include shoulder isometrics (flexion, abduction, internal rotation and external rotation) 10 reps with 10 seconds hold. For range of motion, active assisted range of motion will be done with the help of a wand with the goal to reach upto 90â° flexion and abduction and upto 45â° external rotation. This will be given for a total duration of 4 weeks. |
| Comparator Agent |
Standard post operative rehab protocol including ROM exercises. |
Once the surgery is over, patients can be encouraged to take part in physical therapy and other activities. This is largely due to the availability of medications which suppress pain. Within the first month after surgery, complete bandage usage is essential to minimize inflammatory responses. Mobilizing the shoulder joint typically improves ROM. This is necessary for enhanced functionality without risks, such as capsular adhesion and frozen shoulder (adhesive capsulitis). Finally, in addition to pain relief and mobility recovery, functional recovery includes shoulder strength, endurance, and general functional recovery. In particular, patients should be able to carry out functional activities of the day such as lifting, carrying and reaching for objects. This is an important requirement for completing the normal day’s activities and getting back to work or engaging in other physical activities. The exercises include shoulder isometrics (flexion, abduction, internal rotation and external rotation) 10 reps with 10 seconds hold. For range of motion, active assisted range of motion will be done with the help of a wand with the goal to reach upto 90Ⱐflexion and abduction and upto 45Ⱐexternal rotation. Also placebo high intensity LASER will be given.
This will be given for a total duration of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
o Post-op rotator cuff tear, confirmed via imaging and surgical records.
o Completed rotator cuff repair surgery within the last 4-6 weeks.
o Ability to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
History of malignancy or systemic diseases that could affect healing.
o Inability to participate in physical therapy or follow-up assessments
o Pregnancy or recent childbirth
o Concurrent participation in other experimental therapies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, joint range of motion, functional abilities. |
Baseline, post second week, post fourth week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/12/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Common goals of post-operative rehabilitation following a repair to the rotator cuff include pain management, restoration of joint motion and, in time regaining functional use of the shoulder. The efficacy of current rehabilitation protocols may be limited and in some cases it produces incomplete functional recovery after long-term periods. HILT is a possible alternative treatment that could offer quick and effective relief from pain, improving function more rapidly than traditional joint-based therapy but this remains to be supported through further research. The current study fills this gap in knowledge regarding the efficacy of HILT when added to postoperative rehabilitation. Aim: The aim of the study is to find out the effectiveness of high-intensity LASER on pain, joint range of motion, and functional ability in patients with post operative rotator cuff tears. Objective: 1. To find out the effectiveness of high-intensity LASER on pain in patients with post operative rotator cuff tears. 2. To find out the effectiveness of high intensity LASER on joint range of motion in patients with post operative rotator cuff tears. 3. To find out the effectiveness of high intensity LASER on functional ability in patients with post operative rotator tears. Hypothesis – 1. Null Hypothesis: · There is no significant effect of high-intensity LASER on pain in patients with post operative rotator tears. · There is no significant effect of high-intensity LASER on joint range of motion in patients with post operative rotator tears. · There is no significant effect of high-intensity LASER on functional ability in patients with post operative rotator tears. 2. Alternate Hypothesis: · There is significant effect of high-intensity LASER on pain in patients with post operative rotator tears. · There is significant effect of high-intensity LASER on joint range of motion in patients with post operative rotator tears.. · There is significant effect of high intensity LASER on functional ability in patients with post operative rotator tears. |