Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001299897
Ethics application status
Approved
Date submitted
28/08/2020
Date registered
27/09/2021
Date last updated
23/11/2022
Date data sharing statement initially provided
27/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) pattern for Adhesive capsulitis patients.
Scientific title
Effectiveness of proprioceptive neuromuscular facilitation pattern on upper extremity and scapula along with conventional physiotherapy in patients with adhesive capsulitis.
Secondary ID [1] 302172 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adhesive capsulitis of shoulder 318830 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316838 316838 0 0
Physiotherapy
Musculoskeletal 320916 320916 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Proprioceptive Neuromuscular Facilitation Technique for Upper extremity:

Patient position: The patent will in a supine lying position with the arms beside their body. They will be asked to relax their shoulders.
Therapist position: The therapist will stand beside the affected side of the patient.
Technique: “Flexion-abduction-external rotation” (D2F pattern) with elbow straight pattern of PNF with “hold relax” technique. It is a relaxing tool based on isometric contractions against maximum resistance to improve passive ROM and decrease pain. Isometric contractions for 5-8 seconds will be performed against maximum resistance for not balking antagonist muscles to contract, including a rotation at the limitation point. The technique is repeated a few times at the edge limitation point and then, proceeded. While applying the D2F pattern with elbow straight pattern of PNF, the therapist will use his hand to hold the patient’s upper limb on the opposite side of the hip in a posture of shoulder extension/ adduction/internal rotation, elbow extension, and forearm pronation. The physiotherapist then asks the patient to raise his hand overhead. The patient will attempt to perform this movement, by doing shoulder flexion/abduction/external rotation. During these movements, the therapist will support the patient’s arm with his other hand.
Duration of treatment time: 5 to 7 minutes.
Repetitions: 5 repetitions Hold time: 5 seconds Rest time: 2 seconds
Treatment session: Total 4 weeks, 2 sessions per week.


2. Proprioceptive Neuromuscular Facilitation Technique for Scapula:

A) Anterior Elevation & Posterior Depression
Patient position: The patient lies on the unaffected side
Therapist Position: Standing behind the patient, placing one hand superior
border of scapula and other on inferior angle of the scapula
Procedure: The patient is instructed to Push up and Push down the scapula against the manual resistance given by the therapist.
Repetitions: 5 repetitions Hold time: 5 seconds
Rest time: 2 seconds Session/Day: 2 times per week

B) Posterior Elevation & Anterior Depression
Patient position: Patient lies on the unaffected side.
Therapist Position: Standing behind the patient, placing one hand on the superior border of the scapula and the other on the inferior angle of the scapula
Procedure: The patient is instructed to Push back and Push the front
of the scapula against the manual resistance given by the therapist.
Repetitions: 5 repetitions Hold time: 5 seconds
Rest time: 2 seconds Session/Day: 2 times per week

This group also will receive 8 sessions of 30 minutes of treatment. The total duration of the study will be 4 weeks.
Intervention code [1] 318475 0
Rehabilitation
Intervention code [2] 321518 0
Treatment: Other
Comparator / control treatment
The control group will receive only conventional physiotherapy like capsular stretching, Joint mobilization, IRR etc.
The graduate physiotherapist will provide the intervention.
The mode of delivery will be through physiotherapy sessions in the Physiotherapy outpatient unit.
This group also will receive 8 sessions of 30 minutes of treatment.
The total duration of the study will be 4 weeks.
The location of the intervention occurs will be the Outpatient Physiotherapy department, CRP, Savar, Dhaka-1343.
Control group
Active

Outcomes
Primary outcome [1] 328706 0
To find out the effectiveness of PNF pattern on upper extremity and scapula in Shoulder joint assessed by Shoulder Pain and Disability Index (SPADI)
Timepoint [1] 328706 0
1, 2, 3, 4 weeks of intervention
Secondary outcome [1] 386327 0
The severity of shoulder pain will be assessed using a Numeric pain scale.
Timepoint [1] 386327 0
1, 2, 3, and 4 weeks post-intervention commencement
Secondary outcome [2] 393786 0
Change in Range of Movement (ROM) will be assessed using Goniometer.
Timepoint [2] 393786 0
1, 2, 3, and 4 weeks post-intervention commencement
Secondary outcome [3] 393787 0
The functional performance will be assessed by Shoulder Pain and Disability Index (SPADI)
Timepoint [3] 393787 0
1, 2, 3, and 4 weeks post-intervention commencement

Eligibility
Key inclusion criteria
The inclusion criteria will be a patient diagnosed as unilateral
adhesive capsulitis; Pain in shoulder joint at least one month;
Subjects who are willing to participate in the study.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will be a history of shoulder surgery or manipulation under anesthesia; Neurologic deficits affecting shoulder functioning during daily activities; Pain or disorders of the cervical spine, elbow, wrist, or hand; Other pathological conditions involving the shoulder (rotator cuff tear, tendinitis etc.)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2021
Actual
1/10/2021
Date of last participant enrolment
Anticipated
Actual
22/04/2022
Date of last data collection
Anticipated
Actual
27/05/2022
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 22901 0
Bangladesh
State/province [1] 22901 0
Mymensingh & Savar.

Funding & Sponsors
Funding source category [1] 306596 0
Self funded/Unfunded
Name [1] 306596 0
Abid Hasan Khan
Country [1] 306596 0
Bangladesh
Primary sponsor type
Individual
Name
Abid Hasan Khan
Address
Bangladesh Health Professions Institute CRP-Chapain, Savar, Dhaka-1343.
Country
Bangladesh
Secondary sponsor category [1] 307127 0
None
Name [1] 307127 0
Address [1] 307127 0
Country [1] 307127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306781 0
BHPI Institutional Review Board
Ethics committee address [1] 306781 0
Ethics committee country [1] 306781 0
Bangladesh
Date submitted for ethics approval [1] 306781 0
13/06/2020
Approval date [1] 306781 0
20/06/2020
Ethics approval number [1] 306781 0
CRP-BHPI/IRB/06/2020/396

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104998 0
Dr Abid Hasan Khan
Address 104998 0
Department of Physiotherapy, BHPI. CRP - Savar, Chapain, Savar,
Dhaka-1343, Bangladesh.
Country 104998 0
Bangladesh
Phone 104998 0
+880 1787 378201
Fax 104998 0
Email 104998 0
[email protected]
Contact person for public queries
Name 104999 0
Ehsanur Rahman
Address 104999 0
Department of Physiotherapy, BHPI. CRP - Savar, Chapain, Savar,
Dhaka-1343, Bangladesh.
Country 104999 0
Bangladesh
Phone 104999 0
+880 1716 062263
Fax 104999 0
Email 104999 0
[email protected]
Contact person for scientific queries
Name 105000 0
Ehsanur Rahman
Address 105000 0
Department of Physiotherapy, BHPI. CRP - Savar, Chapain, Savar,
Dhaka-1343, Bangladesh.
Country 105000 0
Bangladesh
Phone 105000 0
+880 1716 062263
Fax 105000 0
Email 105000 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8994Informed consent form    380485-(Uploaded-28-08-2020-16-47-50)-Study-related document.pdf
8995Ethical approval    380485-(Uploaded-28-08-2020-18-32-50)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.