| CTRI Number |
CTRI/2024/01/061843 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bilateral versus unilateral training in shoulder pain |
|
Scientific Title of Study
|
Effectiveness of Bilateral sensorimotor training on upper quadrant function and quality of life in individuals with unilateral rotator cuff related shoulder pain - A randomized controlled trial |
| Trial Acronym |
BILAT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavitha Vishal |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy
Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi KARNATAKA 576101 India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs Kavitha Vishal |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy
Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi KARNATAKA 576101 India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
G Arun maiya |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy
Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9845350823 |
| Fax |
|
| Email |
garunmaiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education
Madhav Nagar
Manipal, Karnataka,India |
|
|
Primary Sponsor
|
| Name |
Kavitha Vishal |
| Address |
Department of Physiotherapy
Manipal College of Health professions
Manipal |
| 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 Kavitha Vishal |
Kasturba Hospital,Manipal |
Department of Physiotherapy
Hand therapy room
Outpatient Unit
Madhav Nagar
Manipal Udupi KARNATAKA |
9986526077
vishalkavitha84@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committtee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Exercises will be only given to the side of rotator cuff related shoulder pain
The sessions will include 10 supervised sessions for 12 weeks. Additionally, they will be provided a home program. Total duration of intervention is 12 weeks. |
| Intervention |
Experimental group |
Exercises will be given Bilateral sensorimotor training to both sides of the upper limb in individuals with unilateral rotator cuff related shoulder pain. Additionally, they will provided home exercise program.
The sessions will include 10 supervised sessions for 12 weeks. Total duration of intervention is 12 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Complains of shoulder pain unilaterally
Positive Hawkins kennedy
Positive Neer impingememt
Postive external rotation stress test |
|
| ExclusionCriteria |
| Details |
Bilateral shoulder pain
Adhesive capsultis
Recent surgery
Cardiopulmaory, inflammatory and neurological conditions affecting the upper extremity
Neck pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Upper limb function
Quality of Life |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
shoulder pain during rest and activity
Shoulder muscle strength
Pressure Pain thresholds
Shoulder proprioception
Shoulder function |
Baseline and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
03/02/2024 |
| 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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
Primary objective: To evaluate the effectiveness of a bilateral sensorimotor training program compared to standard training on upper quadrant function (DASH) and quality of life (WORC) in Individuals with unilateral RCRSP. Secondary objective: To compare the effectiveness of bilateral sensorimotor training compared to standard training on pain intensity (NPRS), pain sensitivity (PPT), active range of motion (ROM), shoulder muscle strength (isometric muscle strength), shoulder joint proprioception (passive to active joint position error), and shoulder function (CMS score). Interventions -both the groups Both the groups will undergo clinical examination including a thorough subjective and physical examination of the shoulder and the spine by the treating physiotherapist. Participants will be asked about the burden of shoulder pain using a semi- structured interview guide until thematic saturation. Data will be analyzed qualitatively using themes and subthemes. The interview will be conducted in English and Kannada. Themes derived will be used to understand the burden and lived experience of shoulder pain. The treatment protocol will be pragmatically delivered based on the clinical examination findings. The experimental group will receive bilateral sensorimotor training (exercises on the involved and the uninvolved side). The control group will receive standard training (exercises only on the involved side). In addition, both the groups will receive education, modalities (heat/cold) stretching exercises, posture correction and mobilization of the glenohumeral joint if indicated. To ensure uniformity in prescription of intervention both the groups will receive same number of sessions and dosages. Both groups will receive a total of 10 supervised sessions over the 12-week period, with each session lasting 45 minutes. The supervised sessions will be scheduled once per week for the first six weeks, followed by four additional sessions spread over the remaining six weeks. In addition to the supervised sessions, participants will perform a home exercise program independently once per day, six days a week, for 12 weeks as per their group assignment Experimental group Participants in the EG received bilateral sensorimotor training. They will perform strengthening, motor control, and proprioceptive exercises on the involved and the uninvolved side simultaneously. The exercise program will be structured into three progressive stages of increasing difficulty, determined by the degree of humeral elevation and greater activity of the RC. Each stage will have general strengthening, rotator cuff-specific strengthening, motor control training, and proprioceptive exercises. Control group Participants in the CG performed standard training on the involved side. The intervention will be usual care provided to patients with RCRSP, including strengthening and/or motor control exercise and proprioceptive exercises, based on the physical examination findings performed only on the involved side. Exercise prescription will be guided by the participant’s adaptive response and pain behaviour of the involved limb. Outcomes will be assessed at three time points, baseline, 6 weeks and 12 weeks |