| CTRI Number |
CTRI/2020/06/026241 [Registered on: 30/06/2020] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) pattern for Adhesive capsulitis patients. |
|
Scientific Title of Study
|
Effectiveness of proprioceptive neuromuscular facilitation pattern on upper extremity and scapula along with conventional physiotherapy in patients with adhesive capsulitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abid Hasan Khan |
| Designation |
Final Year Student |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Department of Physiotherapy,
BHPI.
CRP - Savar, Chapain, Savar, Dhaka, Bangladesh.
7no, Gohailkandi Jamtola, Sadar, Mymensingh, Dhaka, Bangladesh.
1343
Other |
| Phone |
8801787378201 |
| Fax |
|
| Email |
abidhasankhan1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ehasanur Rahman |
| Designation |
Assistant Professor |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Department of Physiotherapy,
BHPI.
CRP - Savar, Chapain, Savar, Dhaka.
1343
Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
ehsanurrahman09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ehasanur Rahman |
| Designation |
Assistant Professor |
| Affiliation |
Bangladesh Health Professions Institute |
| Address |
Department of Physiotherapy,
BHPI.
CRP - Savar, Chapain, Savar, Dhaka.
1343
Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
ehsanurrahman09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Outpatient Musculoskeletal Unit, Centre for the Rehabilitation of the Paralyzed, Savar, Dhaka, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Abid Hasan Khan |
| Address |
Bangladesh Health Professions Institute
CRP-Chapain, Savar, Dhaka-1343. |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ehsanur Rahman |
Centre for the Rehabilitation of the Paralyzed |
Department of Physiotherapy, Out patient Musculoskeletal Unit, CRP - Savar, Chapain, Savar, Dhaka-1343.
|
8801716062263
ehsanurrahman09@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| BHPI Institutional Review Board |
Approved |
| Change in Sample size |
Approved |
| Screen shot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PNF pattern on Upper extremity and Scapula |
In this study, the experimental group will be treated with PNF pattern on upper extremity and scapula in addition with conventional physiotherapy. Graduate physiotherapist will apply the PNF pattern on upper extremity and scapula and the conventional physiotherapies. This group also will get eight sessions of treatment. |
| Intervention |
Structural Diagnosis and Therapy (SDM) |
A common intervention program will be executed for both groups as conventional physiotherapy, it includes - Capsular stretching, Accessory movements, pendulum exercise, pulley exercise, Infra-red radiation and Ultrasound, which are the most frequently, used interventions.This group will receive eight sessions of treatment. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.)
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the effectiveness of proprioceptive neuromuscular facilitation pattern on upper extremity and scapula along with conventional physiotherapy in patients with adhesive capsulitis. |
4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To explore socio-demographic (age, gender, marital status, family type, living area, educational status) characteristics of patients with Adhesive capsulitis.
2. To evaluate severity of pain in patients with Adhesive capsulitis.
3. To measure Improvement of Range of Movement (ROM) for patients with Adhesive capsulitis.
4. To find out the functional performance for patients with Adhesive capsulitis.
|
4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
Study published at BMC Trials Journal. doi: https://doi.org/10.1186/s13063-025-08848-0 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
ABSTRACT Background: Adhesive capsulitis (AC) is a progressive
inflammatory condition of the shoulder that causes functional limitations and
leads to long-term disability. The study aimed to elicit the effectiveness of
Proprioceptive neuromuscular facilitation (PNF) compared to standard
physiotherapy approaches on AC. Methods: An
assessor-blinded single-centre Randomized control trial (RCT) was carried out
on 80 AC patients between May and December 2023 in Bangladesh. Random assigned
and concealed allocated patients were recruited equally (n=40) to each PNF and
conventional capsular stretching group. The experimental group received a PNF
approach, and the control group received capsular stretching to the affected
shoulder for 24 sessions in 6 weeks. Both groups received electrical modalities
as standard treatment. The primary
outcome was pain measured by the Numeric pain rating scale (NPRS) and range of
motion in a universal goniometer. The secondary outcome was functional
limitation measured by the Shoulder pain and disability index (SPADI). As per
the distribution of data, non-parametric tests were employed to analyse the
superiority between and within groups with intention-to-treat analysis. Results: Baseline compatibility was noted in all the key
variables (p > 0.05). Both PNF and
capsular stretching had a decrease in pain compared to baseline in all capsular
pattern positions (p <0.001), and
PNF had more significant improvement compared to control (p < 0.001). Both groups had equal improvement in shoulder ROM (p < 0.001) except abduction (p < 0.05). Both groups had
improvements in disability (p < 0.05),
and PNF had statistical superiority of improvement (p < 0.001).
Conclusions: The findings of this study support the potential of
PNF intervention for 6 weeks as a treatment for shoulder Adhesive capsulitis,
showing improvements in pain, ROM, and functional disability. However, further
multicentre trials with a follow-up design are needed to fully understand the
superiority of PNF on shoulder AC, encouraging continued engagement in this
area of research. |