| CTRI Number |
CTRI/2024/06/068592 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare the outcome of manipulation and hydrodilatation in adhesive capsulitis shoulder |
|
Scientific Title of Study
|
Comparison of the clinical outcome between manipulation and hydrodilatation among patients with adhesive capsulitis of shoulder receiving intra-articular steroid injection - A Randomised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anitha A |
| Designation |
Post graduate Junior Resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Orthopaedics, Pondicherry Institute of Medical Sciences campus, Kalapet, Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9443630565 |
| Fax |
|
| Email |
dranithamgm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prince Solomon |
| Designation |
Professor and Head of the department |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Orthopaedics, Pondicherry Institute of Medical Sciences campus, Kalapet, Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9489390335 |
| Fax |
|
| Email |
princesolomon_80@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prince Solomon |
| Designation |
Professor and Head of the department |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Orthopaedics, Pondicherry Institute of Medical Sciences campus, Kalapet, Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9489390335 |
| Fax |
|
| Email |
princesolomon_80@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics,
Pondicherry Institute of Medical Sciences, Pondicherry- 604303 |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences,
Ganapathichettikulam, Pondicherry-604303 |
| Type of Sponsor |
Private medical college |
|
|
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 Anitha A |
PONDICHERRY INSITUTE OF MEDICAL SCIENCES |
NO 101, Department of Orthopaedics, Pondicherry Institute of Medical Sciences,Kalapet, Pondicherry.
Pondicherry
PONDICHERRY |
9443630565
dranithamgm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra-articular steroid Injection in hydrodilatation and manipulation |
GROUP B: Patient will be receiving intra- articular steroid injection and hydrodilatation-(A mixture of 1 ml of 40mg/ml triamcinolone acetonide, 2ml bupivacaine and 30 ml saline) the injection site was determined by palpating coracoid process. Injection site was marked 2cm inferior and lateral to coracoid process and a needle tip was inserted at this site and directed towards glenohumeral joint.Duration of the procedure will be 30 to 45 mins |
| Intervention |
Intra-articular steroid Injection in hydrodilatation and manipulation |
Patient will be randomized into two groups of 26 patients each by computer generated random numbers obtained after institutional ethical committee clearance
GROUP A: Patient will be receiving Intra- articular steroid injection (A mixture of 1 ml of 40mg/ml triamcinolone acetonide and 2ml of bupivacaine )the injection site was determined by palpating coracoid process. Injection site was marked 2cm inferior and lateral to coracoid process and a needle tip was inserted at this site and directed towards glenohumeral joint. and manipulation of shoulder sequentially through range of forward flexion, external rotation, external rotation, Abduction and internal rotation under anaesthesia. Duration of the procedure will be 30 to 45 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Unilateral frozen shoulder
2) Primary frozen shoulder, with no relief after physiotherapy and analgesics for a period of 3 months.
3) Loss of passive motion of the glenohumeral joint of 30 degree in at least 2 directions ( Flexion, extension, external rotation, internal rotation , abduction, adduction )
4) Patient more than 18 years of age |
|
| ExclusionCriteria |
| Details |
1)Secondary frozen shoulder
2)Patient with any injury in the ipsilateral shoulder joint
3)Rotator cuff tear / tendinitis
4)Previous history of intra articular steroid injection within three months
5)Patient with glenohumeral joint arthritis – Confirmed with xrays
6) Skin lesions over shoulder region
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the pain outcome using VAS score, shoulder disability by SPADI score |
Pain and disability is assessed on 3 weeks, 6 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the improvement in disability in patient suffering from adhesive capsulitis |
Disability is assessed on 3 weeks, 6 weeks and 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2024 |
| 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="2"
Months="0"
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
|
This study will be carried out after getting approval from institutional research and ethical committee. 52 patients undergoing manipulation under anaesthesia who fulfils the inclusion and without any exclusion criteria will be randomized into two groups using computer generated random numbers. .A pre anaesthetic evaluation will be done for all the patients. The informed and written consent will be obtained after explaining the procedure to all patients. Patient were then divided into two groups using block randomization. Case assigned to group A will receive intra articular steroid and manipulation under anaesthesia whereas in group B will receive intra-articular steroid injection and hydrodilation using normal saline. In both the group of patient the VAS and SPADI score were recorded at the time of presentation and post the intervention. Both the groups will undergo Physiotherapy and home exercise programme. And participants will be followed up by recommendation of usage of home diary for ensuring the adherence of physiotherapy exercises. Follow up of the case will be done post operatively, 3 weeks, 6 weeks and 12 weeks.
|