| CTRI Number |
CTRI/2025/03/081565 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Proprioceptive neuromuscular facilitation] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of PNF exercises in non specific low back pain |
|
Scientific Title of Study
|
Effectiveness of proprioceptive neuromuscular facilitation exercises in decreasing pain severity, increasing range of motion, balance, proprioception and regional function in individuals with non specific low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhinakaran J |
| Designation |
Postgraduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), No.1 Ramachandra Nagar, Porur Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
8825839428 |
| Fax |
|
| Email |
dhinajeeva21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subbiah K |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), No.1 Ramachandra Nagar, Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Subbiah K |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), No.1 Ramachandra Nagar, Porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), No.1 Ramachandra nagar Porur Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Dhinakaran J |
| Address |
Sri Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be university), No.1 Ramachandra Nagar, Porur Chennai 600116 |
| 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 Dhinakaran J |
sri ramachandra faculty of physiotherapy sri ramachandra institute of higher education and research |
Physical Rehabilitation Department, Ground Floor New Block OPD Faculty of physiotherapy Sri Ramachandra Institute of Higher Education and Research(Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai- 600116
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
8825839428
dhinajeeva21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education And Research Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
general strengthening exercises |
The control group will be receiving general trunk exercise programme consisting of trunk curl-up, diagonal trunk curl and single-legged extension. The participants will attend three exercises lasting for about 30 min three times a week over three weeks. All exercises will be performed in three sets of 10 repetitions, with a 30 s rest between repetitions and a 60 s rest between sets. Total duraiton of 3 weeks. |
| Intervention |
Proprioceptive neuromuscular facilitation exercises |
Week one patient will be receiving Isometric contractions for trunk flexors and extensors against maximum resistance. Week two patient will be receiving Isometric concentric and eccentric contractions, 5-second resisted concentric trunk flexion, followed by 5-second isometric contraction in flexion and then a 5-second resisted eccentric contraction of trunk flexion. Week three Diagonal and spiral directions chop and lift against maximum resistance generated by the physical therapist. Exercises from week one are repeated in weeks two and three, while exercises from week two continue into week three. They will undergo 3 sets of 15 repetitions with rest interval of 30 seconds between the sets and 60 seconds after completing 15 repetitions. Total duration of 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non specific low back pain
Age from 18 to 50 years Both male and female |
|
| ExclusionCriteria |
| Details |
Previous history of spine surgery
Neurological deficits
Patient already received regular PNF training
Cancer
Specific LBP Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity(Numerical pain rating sacle) |
baseline,6weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proprioception (baseline inclinometer) |
Baseline, 6weeks |
| RMDQ |
Baseline, 6weeks |
| lumbar range of motion |
Baseline, 6weeks |
| balance |
Baseline, 6weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/03/2025 |
| 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="5"
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
|
A Quasi experimental study will be conducted in patients with Low back
pain. The sample will be recruited from patient attending physiotherapy
OPD in Sri Ramachandra Hospital. Individuals with low back pain of both
genders, an age between 18 to 50 years of age. The individuals will be
selected based on the inclusion and exclusion criteria. Written consent
forms will be obtained from the willing individuals. Among the two groups
the experimental group will be receiving PNF exercises whereas the
control group will be receiving conventional training for low back ache.
The participants in the experimental group will attend each individual
training session for three times a week . They will undergo 3 sets of 15
repetitions with rest interval of 30 seconds between the sets and 60 seconds
after completing 15 repetitions. The difference between the treatment and
the comparison group is measured using the following outcome measures
Proprioception (baseline digital inclinometer), RMDQ (Roland-Morris
Disability Questionnaire), NPRS, Range of motion, Balance postural sway
system. |